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On Serious Healthcare, Some Bizarre Decisions

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On August 04, 2016, it was widely reported by the media that the Union Minister of Chemicals and Fertilizers – Mr. Anant Kumar, would launch a new digital initiative of the National Pharmaceutical Pricing Authority (NPPA), named, “Search Medicine Price”, on August 29, 2016.

This is an app developed by the National Informatics Centre, for android smartphones ‘that will enable patients to check the prices of essential medicines on-the-go’. It will be an extension of NPPA’s “Pharma Jan Samadhan” web-portal facility. The Indian price regulator believes that wide use of this app would successfully reduce the instances of overcharging the consumers by the pharma companies and retail chemists, especially for lifesaving, and other expensive medicines. 

India’s drug pricing watchdog is planning to introduce this app to enable the patients check the prices of essential medicines on-the-go, and expects that this measure will hold drug companies and medicine retail outlets more accountable to patients.

In the test version of the app, which has since been released for stakeholder feedback, patients can search for the ceiling price of all medicines under the National List of Essential Medicines (NLEM), on the basis of its generic name and the state they’re buying it from.

The Chairman of NPPA, reportedly, further said, “Consumers can use the app before paying for a medicine to ensure that they get the right price. At present, whatever action we take against the companies, including recoveries, the consumer does not get back the overcharged amount he or she has paid.”

Good intent with a basic flaw:

The intent of the Government in this regard is indeed laudable. However, the initiative seems to underscore the blissful ignorance of the prevailing ground realities in India.

The media report highlights that with this app, the patients can search for the ceiling price of all medicines featuring in the NLEM on the basis of their generic names.

Whereas, the ground reality to make any meaningful use of this app is quite different. This is primarily because, in the Indian Pharmaceutical Market (IPM), over 90 percent of drugs are branded generics. An overwhelming majority of the doctors, as well, follow this trend while writing prescriptions for their patients, in general. For any single ingredients or Fixed Dose Combination (FDC) formulation, there are as many as even 30 to 40 brands, if not more. 

In that case, when the prescriptions given to patients are mostly for branded generic drugs, how would that person possibly get to know their generic names, to be able to check their ceiling prices with the help of the new “Search Medicine Price” app?

Not just a solitary example: 

This is just not a solitary instance of ignorance of the Government decision makers on the realities prevailing in the country.

With an admirable intent of making drugs more affordable for increased access, especially, to all those patients incurring out-of-pocket health expenditure, the Government has been taking several such measures, and is also trying to create a hype around these. Unfortunately, most of these efforts, miss the core objective of increasing access to drugs at the right price, by miles. 

Another recent example: 

This particular example, in my view, is even more bizarre.

It happened on February 29, 2016, the day when the Union Budget proposal for the financial year 2016-17 was presented before the Parliament of India.

In this budget proposal, the Union Finance Minister announced the launch of ‘Pradhan Mantri Jan-Aushadhi Yojana (PMJAY)’. 3,000 Stores under PMJAY will be opened during 2016-17.

Many consider this scheme as a repackaged old health care initiative, only adding the new words ‘Pradhan Mantri’ to it.

Just to recapitulate, Jan-Aushadhi is an ongoing campaign launched by the Department of Pharmaceuticals in 2008, in association with Central Pharma Public Sector Undertakings (PSU), to provide quality medicines at affordable prices to the masses.

Under this scheme, Jan Aushadhi Stores (JAS) are being set up to provide generic drugs, which are available at lesser prices, but are equivalent in quality and efficacy as expensive branded drugs.

The Department of Pharmaceuticals had initially proposed to open at least one JAS in each of the 630 districts of the country, so that the benefit of “quality medicines at affordable prices” is available to at least one place in each district of India.

If the initiative becomes successful, based on its inherent merit and the cooperation of all stakeholders, the scheme was to be extended to sub divisional levels as well as major towns and village centers by 2012. However, after 5 years, i.e. up to February, 2013, only 147 JAS were opened, and out of those only 84 JASs are functional. 

More recently, according to a June 02, 2015 report, “under the new business plan approved in August 2013, a target of opening 3,000 Jan Aushadhi stores during the 12th plan period i.e. from 2013-14 to 2016-17 was fixed. As per the Standing Committee on Chemicals and Fertilizers report in March 2015, till date only 170 JAS have been opened, of which only 99 are functional.”

Tardy progress:

The tardy progress of the scheme was largely attributed to:

  • A lackluster approach of State governments
  • Poor adherence to prescription of generic drugs by doctors,
  • Managerial/ implementation failures of CPSU/ BPPI.
  • Only 85 medicines spread across 11 therapeutic categories were supplied to the stores and the mean availability of these drugs was found to be 33.45 percent, with wide variations across therapeutic categories. 

There is no doubt, however, the intent of ‘Pradhan Mantri Jan-Aushadhi Scheme’ of 2016 is as laudable as the earlier “Jan-Aushadhi Scheme”, launched by the Department of Pharmaceuticals in 2008, was at that time. But, the moot question that comes at the top of mind:  Is it robust enough to work effectively in the present situation? 

Why it may not fetch the desired outcome?

Besides strong support from the State Governments, and other factors as enlisted above, making the doctors prescribe drugs in generic names would be a critical issue to make the “Pradhan Mantri Jan-Aushadhi scheme’ a success, primarily to extend desirable benefits to a sizeable section of both the urban and rural poor. Another relevant question that comes up now, how would the Government ensure that the doctors prescribe drugs in the generic names?

A critical challenge:  

Since, the generic drugs available from ‘Jan Aushadhi’ retail outlets are predominantly prescription medicines, patients would necessarily require a doctor’s physical prescription to buy those products.

Despite some State Government’s circulars to the Government doctors for generic prescription, and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, that states: “Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs”, the doctors, in India, prescribe mostly branded generics. It includes even many of those prescriptions, generated from a large number of the Government hospitals.

The legal hurdle for generic substitution:

In a situation such as this, the only way the JAS can sell more for greater patient access to essential drugs, if the store pharmacists are allowed to substitute a high price branded generic with exactly the same generic molecule that is available in the JAS, without carrying any brand name, but in the same dosage form and strength, just as the branded ones. 

However, this type of substitution would be grossly illegal in India. This is because, the section 65(11)(c) in the Drugs and Cosmetics Rules, 1945 states as follows:

“At the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed. 20[(11A) No person dispensing a prescription containing substances specified in 21[Schedule H or X] may supply any other preparation, whether containing the same substances or not in lieu thereof.]” 

Thus, I reckon, the most important way to make ‘Jan Aushadhi’ drugs available to patients for greater access, is to legally allow the retailers substituting the higher priced branded generic molecules with their lower priced equivalents, sans any brand name.

A move that did not work:

Moving towards this direction, the Ministry of Health had reportedly submitted a proposal to the Drug Technical Advisory Board (DTAB) to the Drug Controller General of India (DCGI), for consideration.

In this proposal, the Health Ministry reportedly suggested an amendment of Rule 65 of the Drugs and Cosmetics Rules, 1945 to enable the retail chemists substituting a branded drug formulation with its cheaper equivalent, containing the same generic ingredient, in the same strength and the dosage form, with or without a brand name.

However, in the 71st meeting of the DTAB held on May 13, 2016, its members reportedly turned down that proposal of the ministry. DTAB apparently felt that given the structure of the Indian retail pharmaceutical market, the practical impact of this recommendation may be limited.

Conclusion:

Considering all this, just as ‘Pradhan Mantri Jan Aushadhi Yojana’, the likes of ‘Search Medicine Price app’, apparently, are not potentially productive health care related initiatives, if not just one-offs, ‘feel good’ type of schemes for the general population. 

These are not robust enough either, to survive the grueling of reality, impractical for effective implementation, and thus, seriously handicapped to fetch any meaningful benefits for the patients, on the ground.

It is, therefore, still unclear to me, how would the needy patients, and the Indian population at large, could derive any benefit from such bizarre decisions, on so serious a subject as health care.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

NCDs: Any Wolf Around, In Sheep’s Clothing? 

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Noncommunicable Diseases (NCDs), such as, cancer, cardiovascular disease, diabetes and chronic respiratory disease, are now the leading cause of death in the world, accounting for 63 percent of annual deaths. Over 80 percent of NCDs occur in lower or middle income countries.

Moreover, wide prevalence of NCDs and inadequate patients’ access to related drugs have a profound negative impact on the economic progress of any country. According to various reports, the increase of around just one year of a country’s average life expectancy, could increase its GDP growth by around four percent.

Since long, the global drug industry has been contributing immensely to discover and bring to the market various amazing medicines to effectively treat a spectrum of NCDs. It is still happening, but with a stark different impact on the majority of the patients, across the world. 

There are many important aspects to NCDs, such as, public and private initiatives in their prevention, continuous screening, proper diagnosis, providing most effective treatment, and population’s lifestyle management for more effective disease control. However, in this article, I shall focus only on modern drug pricing, as one of the key barriers for patients’ access to modern drugs for the treatment of these ailments.

Saying something, and doing something else:

In this context, some large pharma lobby groups pontificate that the drug industry recognizes the economic and social impact of NCDs. Many of them also try to widely publicize, that they are working with various stakeholders, such as, the Governments, other payers and patients’ groups, as an active solution partner in lessening this burden. 

Yes, some of them do actively support some programs, mostly to prevent, screen and diagnose these chronic ailments. There are also instances when they try to showcase some of their occasional and complicated, so called ‘patient access’ programs.

Interestingly, a global major even wanted to reap a rich harvest by highlighting one such initiatives to win a patent litigation in the Supreme Court of India. As many would know, the Apex Court of the country did not take cognizance of its real value to patients, as projected by the concerned company, while dictating its final judgement on the Glivec case.

To many independent experts, these could most probably be part of a grand façade to justify the high drug prices, which most of the patients can’t afford, and also is an attempt to manage their fast eroding overall public image. On the other hand, they ‘religiously’ continue to keep increasing the drug prices arbitrarily, including those of NCDs. I shall dwell on it below.

Impeding patient access to modern drugs:

Despite all these developments, the issue of general affordability of most effective available drugs, even by the payers, such as, many Governments and the health insurance companies, are seriously impeding the patient access to these medicines.

Such exorbitant treatment costs with modern and more effective drugs is creating almost an impregnable barrier for access to these medicines, mostly for those patients incurring Out-of-Pocket (OoP) expenditure on health care. In a situation like this, where the volume sales do not increase significantly, to maintain the business growth the manufacturers of these drugs further hike up their product prices to a jaw dropping level, as perceived by both the patients and the payers.

This overall pricing environment is now posing a major challenge to many even in many developed countries of the world, including the United States.

Even the sky is not the limit:

Today, for a drug price increase not even the sky is the limit. Recently, the Census Bureau, Commerce Department of the United States (US) announced May 2016 sales of merchant wholesalers of various industries in the country. According to this report, the total pharma sales by manufacturers to pharmacies, hospitals, and others in the distribution chain reflected a buoyant increase of a hefty 11.3 percent from a year ago, especially when most other sectors showed sluggishness in growth.

The obvious question, therefore, that comes up, are the Americans now consuming more pharmaceutical products than in the past? The answer, however, is negative, though not very surprising to many.

In that case, is this increase in growth coming primarily from price increases of drugs, which are mostly used for the treatment of chronic ailments? The answer now will be an affirmative one. 

How much price increase is enough?

This question becomes quite relevant, when a large section of even Americans starts raising their voices against high drug price, as it is adversely impacting their access to those drugs. 

If this question is put slightly differently, such as, when Apple Inc. can take an annual price increase of around 10 percent for its iPhones in the Unites States (US), how much drug price increases the pharma companies are possibly taking every year in the same country? This interesting point was deliberated in an article published in The Wall Street Journal (WSJ) on July 14, 2016. 

Price increases driving growth:

According to this article, pharmaceutical prices in the US rose by 9.8 percent from May 2015 through May 2016. This is the second-highest increase among the 20 largest products and services tracked by the Bureau of Labor Statistics’ Producer Price Index, with investment services ranking first.

Majority of pharma companies keeps increasing prices also for a large section drugs used in the treatment of NCDs, which require almost lifelong therapy for the patients to lead a normal and meaningful life.

I am trying to give below a flavor of such drug price increases, both for NCDs and communicable diseases, quoting a few examples from the above WSJ article:

  • Biogen Inc. reported a 15 percent increase to US$ 744.3 million in US sales of its Multiple Sclerosis (MS) drug Tecfidera in the first quarter, primarily due to price increases. The local revenue for Biogen’s other biggest-selling products, Avonex, used in the relapsing form of multiple sclerosis, and Tysabri used in multiple sclerosis and Crohn’s disease, also benefited from higher prices.
  • The sales of Giliead Science’s Truvada, used as a preventive treatment for HIV rose 16 percent in the quarter, on the back of higher prices, and also increased use as a preventive treatment for HIV.
  • Global sales of Amgen Inc.’s anti-inflammatory drug Enbrel rose 24 percent in the first three months of the year, driven primarily by a higher net selling price.
  • US sales for AbbVie Inc.’s anti-inflammatory drug Humira rose 32 percent in the first quarter, due to price increases and higher prescription volume. 
  • Pfizer Inc.’s US price increases and, in some cases greater prescription volume, helped drive higher revenue for nine drugs representing US$2 billion in US revenue.

Payers have started reacting:

Responding to this development, Express Scripts’ National Preferred Formulary (NPF) of the US, which is one of the most widely used drug list in the United States, providing prescription drug coverage guidelines for 25 million Americans, has excluded many drugs from its 2017 list. This exclusion covers some brands, such as, Novo Nordisk’s blockbuster GLP-1 diabetes drug Victoza and two of its top-selling insulins.

Similarly, another large American retail and health care company CVS Health’s 2017 formulary does not feature, among many other drugs, Sanofi’s blockbuster insulin Lantus along with its follow-up Toujeo, making it the largest commercial product ever excluded from a formulary. 

‘The playbook used for a number of years is over’:

In an article of August 04, 2016 titled, “Drug lobby plans a counterattack on prices”, a senior director of the public affairs firm APCO Worldwide, which represents several drug companies, and a former HHS official under President George W. Bush was quoted saying, in the context of pharma companies and their lobby groups that, the reality, the message and the playbook used for a number of years is over. The industry can no longer defend high drug prices by pointing to the pricey research and development that goes into innovative medicines. They have to move on, he added.

Indian scenario:

The Indian scenario is much worse, with OoP expenditure on drugs being around 70 percent of the total treatment cost. It could be even more, if only NCDs are considered. This situation raises a red flag, especially considering the WHO report released on January 20, 2015 that highlights NCDs are estimated to have accounted for 60 per cent of the deaths in India in 2014.

Some of the examples are as follows:

  • An ICMR-INDAIB study, published in September 2011, on diabetes prevalence in India indicate that the epidemic is progressing rapidly across the nation, and has already affected a total of 62.4 million persons in 2011. With proper diagnosis and screening this figure may increase to a dangerous level in India.
  • According to WHO, almost 2.6 million Indians are predicted to die due to coronary heart disease (CHD), which constitutes 54.1 percent of all CVD deaths in India by 2020. 
  • A March 2012 ‘The Lancet’ study found that nearly six lakh Indians die of cancer every year, with 70 percent of these deaths between the ages of 30-69 years.
  • A report titled “Dementia in Asia Pacific Region” released in November 2014, at the 17th Asia Pacific Regional Conference of Alzheimer’s Disease International (ADI) states that by 2050, the number of people in India suffering from dementia will rise to over 12 million.

Carefully assessing the enormous pharma business opportunity, mainly due to increasing health awareness and fast growing per capita income in the country, pharma players operating in India have become very active in the NCD area, in different ways. However, one strategy remains unchanged, which is continuous increase in modern drug prices, even at the cost of volume increase, frequently taking them beyond affordability of a large section of patients in India. 

Indian Government also reacted:

Recognizing, and basically to address this critical problem, just as what has is now happening in other parts of the globe too, the Union Ministry of Health was compelled to take strong measures, especially in the absence of Universal Health Care (UHC) in India. The Government recently revised the National List of Essential Medicines (NLEM) by adding many more modern drugs for NCDs in the list, to facilitate bringing them under the drug price control mechanism of the country.

Many company’s evading drug price control:

The Union Chemicals and Fertilizers minister Mr. Ananth Kumar informed the Rajya Sabha of the Indian Parliament on July 28, 2016 that various drug price regulatory measures taken by the government have helped consumers save Rs 4,988 crore over the last two years.

This saving may well be just on the paper. On the ground, have the consumers been really benefited out of these measures, and if so, to that much extent? 

The answer wouldn’t be too ferret out, when one takes into account the reply of the Minister of State for Chemicals and Fertilizers, Mr. Hansraj Gangaram Ahir to the Lok Sabha of the Parliament on March 08, 2016. The Minister informed the lawmakers that the National Pharmaceutical Pricing Authority (NPPA) is trying to recover a whopping Rs 4,551 crore, including interest, from various pharma companies for overcharging as of February 2016. Out of this total amount, Rs 3,698.32 crore, representing about 82 per cent of the total outstanding amount, is under litigation in various High Courts and Supreme Court spreading across 1,389 cases, the Minister further said.

The question, therefore, arises, how much benefit of the drug price control of essential medicines is actually benefitting the patients, and how much is being evaded by the pharma players?

Price increases driving Indian pharma industry growth:

In India too, a large number of pharma companies are increasing prices, including a large proportion of those drugs, which are used in the treatment of NCDs, requiring almost lifelong therapy for the sufferers to lead a normal and meaningful life.

The exorbitant treatment cost for many NCDs, with the modern and more effective drugs, is seriously impeding the patient access. As a cascading effect, the manufacturers of these drugs are further jacking up their prices to a much higher level for achieving their business growth objectives. This is very similar to what is happening also in the developed countries, including the US. 

That price increases are primarily driving the growth of the Indian Pharmaceutical Market (IPM) is vindicated by the following table, which has been compiled from the monthly retail audit reports of the well-reputed organization AIOCD Pharmasofttech AWACS Private Limited:

IPM growth through price increases versus volume (July 2015 to June 2016):

Growth % Jun 16 May April Mar Feb Jan 16 Dec 15 Nov Oct Sept Aug July 15
Price 3.8 5.0 4.5 5.1 5.4 5.1 5.2 1.0 13.2 9.9 13.2 12.9
Volume -0.6 -4.4 3.2 -5.3 3.7 1.3 2.8 5.0 5.5 1.4 1.6 3.3

Source: Monthly Retail Audit of AIOCD Pharmasofttech AWACS Pvt. Ltd

Conclusion:

Around the world, arbitrary drug price increases almost on a continuous basis, including in the low inflation countries that may now include India, has sparked-off a raging global debate. Even the Presidential nominees for the forthcoming general election in the United States are taking keen interest on the subject.

As highlighted in a recent issue of the magazine Politico, powerful pharma lobby groups are also gearing up to spend hundreds of millions of dollars to counter this ‘threat’, as perceived by them.

A number of hectic activities in this area, apparently, have started in India too, mainly to divert the focus of the stakeholders from arbitrary drug price increases to other important areas such as, NCDs. This usually happens by making the vested interests eulogizing how much good work these pharma companies are doing in this particular area, only to serve the patients’ health interest. 

Many global pharma players seem to still believe that the same old message from the same old playbook would work even today, at least in India, to defend high drug prices on the contentious ground of pricey R&D that goes into innovative medicines. I reckon, almost gone are those days, even in India.

NCDs need to be fought, unitedly, with effective public, private initiatives and without any self-serving agenda of any participants. The issue needs to deliberated not in the five-star hotels, neither in front of a captive audience, nor with an intent of getting favorable media coverage, but on the real ground, along the general population, both in the urban and the hinterlands of India.

These initiatives would appear praiseworthy to many, when the ultimate aim of any stakeholder, including the doctors and the pharma players, won’t be to make the consumers consume more of high priced medicines, in many cases even by selling their frugal assets. The key aim, I believe, should be to facilitate prevention, screening, diagnosis and treatment with affordable modern medicines, and finally to help manage the ailments well, through the rest of the life of any sufferers.

In the battle against NCDs, it is also important to know well and segregate, if there is any wolf around, in sheep’s clothing.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Drugs & Devices: Chasing Never-Enough Profit And Price Control

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On July 20, 2016, the Union Ministry of Health of India announced the addition of Coronary Stents to the National List of Essential Medicines (NLEM) 2015 with immediate effect, bringing them under the Drug Price Control Order.

Reacting sharply to this development, the medical device industry commented, with an undertone of threat, that this price cap could stop manufacturers from introducing technologically advanced stents in India.

However, without contributing to any further knee-jerk reaction, let me try to analyze in this article, whether the never-enough profit motive of the imported stent manufacturer prompted the Government to resort to price control for these life saving devices.

The use of stent:

In the treatment of coronary artery diseases, cardiac stents are now widely preferred in India, just as many other countries of the world. These are small expandable tubes, usually made of metal mesh, and are used to treat narrowed or weakened arteries in the body. 

One of its most extensive usages is in patients with Coronary Heart Disease (CHD), caused by the buildup of plaque, where stents are used to open narrowed arteries and help reduce the symptoms, such as, chest pain or angina, or to help treat a heart attack. This procedure of a percutaneous coronary intervention (PCI) is called angioplasty. 

According to the report of an experts’ sub-committee formed by the Government in October 2015, around 25 percent of deaths in India is attributed to Cardio Vascular Disease (CVD). Coronary Artery disease (CAD) is the commonest CVD accounting for 90-95 percent of all CVD cases and related deaths.

However, for a large majority of the Indian population, the cost of angioplasty is prohibitively high. A patient may have to shell out anywhere between around Rs. 60,000 and Rs. 150,000 for a stent coated with drugs, called Drug Eluting Stent (DES), to curb restenosis, according to published reports.

Even for most Government staff, the cost of angioplasty could well be several times more than their maximum reimbursable limit fixed for angioplasty. Thus, only around 3 out of 1000 needy coronary heart disease patients are treated with angioplasty in India, as compared to 32 in the United States.

An opportunity to shape up:

Despite DES being notified as drugs under the Drugs and Cosmetics Act, 1940, the coronary stents did not feature in the National List of Essential Medicines (NLEM) prior to the above notification, and therefore, were not covered by the Drug Price Control Order (DPCO), so far.

For a long time, this situation offered an important opportunity to the imported stent manufacturers to shape up with responsible pricing…but did they?

Why is angioplasty cost so high?

While trying to find out a credible answer to the above question, the following details on DES of Abbott Healthcare are worth looking at. This information was sourced from a Maharashtra FDA report, and referenced by Rema Nagarajan in her article published in the Times of India on September 25, 2014 to highlight why is DES so expensive for patients in India.

Although, pricing details are of 2014, nevertheless, it gives a flavor of the prevailing situation:

Cost Break-Up/Unit Cost per Unit (Rs.)
DES imported into India at 40,710
Sold to Distributor Sinocare at 73,440
Distributor Sold to Hinduja Hospital 1,10,000
Patient charged 1,20,000 (threefold increase of import price)

(Source: Maharashtra FDA report)

The saga of ‘Market driven pricing’:

Both the drug and the device companies apparently make valiant efforts to package such ‘arbitrary’ pricing as so called ‘Market Driven’ ones, though such price tags keep crippling many cardiac patients financially too. Ironically, the saga still continues.

Taking advantage of the free-pricing environment in India for Coronary Stents, to attain market dominance many global majors, possibly believe that they can print any Maximum Retail Price (MRP) on their import cost. It was happening even when the Government does not levy any customs duty on stents. Do these companies ignore its optics too? Who knows? 

Like most drugs, market forces do not play any significant role in the medical device pricing too, globally.

In June 2013, a research study published in the ‘American Heart Journal (AHJ)’, compared the use of Bare-Metal Stents (BMS), Drug-Eluting Stents (DES), and Balloon Catheters according to company presence in the hospital. It concluded that Medical Representative (MR) presence was associated with increased use of the concerned company’s stents during percutaneous coronary interventions. The effect was more pronounced with the use of DES, and resulted in the higher procedural cost of US$ 250 per patient.

In this particular study, it was found that DESs were used in about 56 percent of the cases, when the MRs concerned were at the hospital, against 51 percent when they weren’t there.

The situation is not terribly different in India too, where also the medical choices are often influenced by the drugs and device makers through, much discussed, dubious means.

The market:

According to a market research report of ‘Future Market Insights (FMI)’ dated May 09, 2016, the coronary stent market of India was of US$ 481 million in 2015, and by the end of 2016 is expected to reach at US$ 531 growing at a CAGR of 14.0 percent over the forecast period of 2016 – 2026.

This study segmented the market on the basis of the following product types:

  • Drug Eluting Stent (DES)
  • Bare Metal Stent (BMS)
  • Bioresorbable stent (BVS) 

DES segment is expected to exhibit the highest growth and the BMS segment a stable growth, during the forecast period. This is mainly attributed to the emergence of new and more effective stents in the market, the report highlights. 

The market is dominated by the imported stents. Abbott, Medtronics, Meril Lifesciences and Boston Scientific, hold together around 60 percent share of the Indian market.

In India, nine of the 11 domestic stent manufacturers are located in Surat and Vapi of Gujarat. These stents are picking up the market share currently hovering around 30 percent, costing even less than half, as compared to the imported ones.

The Government stepped in:

When the industry did not seem to shape up, despite the regulatory opportunity available to keep the stents out of the NLEM, the media started writing about it, strongly and quite frequently. These were intended to bring some sanity into the imported and advanced Coronary Stent pricing system. Still nothing changed, and the Government had to step in.

Ultimately, in October 2015, the Union Ministry of Health constituted a sub-committee of expert cardiologists under the chairmanship of Prof. Y.K. Gupta, Head of the department of pharmacology, All India Institute of Medical Sciences (AIIMS). The mandate of this sub-committee was to examine the issues relating to the essentiality of coronary stents, and recommend whether the coronary stents should be included in the NLEM.

Accordingly, after a series of in-depth discussion with various stakeholders, which included stent manufacturers and the patient groups, the sub-committee recommended the inclusion of two categories of coronary stents, namely the DES and BMS in the NLEM. This suggestion was in response to “the enormous need of percutaneous coronary intervention, or angioplasty with stent.”

By a notification on July 20, 2016, the Ministry of Health announced that the sub-committee has submitted its report to the Government, and after thorough examination of the report, its recommendations have been accepted for implementation with immediate effect.

This decision of the Government is expected to set the stage for the National Pharmaceutical Pricing Authority (NPPA) to work out ceiling prices, which are expected to be 40 percent to 70 percent less than the current prices for these stents.

Conclusion:

For the last several years, many stakeholders, including the media and the Government, have been expressing grave concern over the exorbitant prices of the Coronary Stents.

Earlier in 2015, following a petition, even the Delhi High Court directed the Government to monitor the prices of stents in the market.

Indian drug price regulator, the NPPA, and some state FDAs too flagged the point that although locally manufactured stents are much cheaper, doctors and hospitals continue to use the imported ones, for various commercial and other reasons. As a result, the situation remained the same, adversely affecting the health of a large number of cardiovascular patients in India.

The last week’s decision of the Indian Government for inclusion of coronary stents in the NLEM, needs to be viewed under the backdrop of steep increase in the incidence of CHD in India. It clearly poses a significant public health hazard, where the cost of stents becomes a key treatment barrier for the majority of the patients incurring out-of-pocket health expenditure.

Price control of drugs and devices may not be the best way to improve their access to the most of the Indian population. Nevertheless, considering the high out-of-pocket expenditure for health care in the country, instead of behaving responsibly, doesn’t the drug and the device makers’ mindless chase after ‘never-enough profit’ objectives, often prompt the imposition of regulatory price control?

The fact that many global drug and device manufacturers, even after posting over 30 percent standalone net profit growth in India, continue cribbing incessantly about the stifling Regulatory and Intellectual Property Right (IPR) environment in the country, vindicates the above point well, possibly beyond any reasonable doubt.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

 

An Emerging Yo-Yo Syndrome With Biosimilar Drugs

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Competition from Biosimilar drugs poses a threat of a combined revenue loss of estimated US$ 110 billion of those pharma players who are still enjoying market monopoly with patented biologic brands. This is expected to surely happen, in the long run, if the signals picked up from the evolving scenario continue to stay on course.

Simply speaking, generic versions of original biologic drugs are termed as Biosimilars. These are large protein molecules, created from living organisms following complex processes. Thus, it is significantly more expensive to develop and market biosimilar drugs, as compared to any small molecule generic chemical ones. 

Hurdle creation and the core intent: 

Despite these complexities, for quite some time, global original biologic drug players had initiated intense campaign to create tough hurdles in the process of regulatory and marketing approval for biosimilar drugs, predominantly raising safety concerns. A simultaneous campaign was also launched among doctors and the payers in the developed countries, stoking the same fear, to forestall the overall acceptance of biosimilar drugs.

When drug regulators of different countries are solely responsible to ensure patient safety of any drug, why are the global pharma companies, and their trade associations are continually shouting from the roof top expressing concerns in this regards? It is often seen that such campaigns become more intense, when it comes primarily to block or delay the entry of biosimilar, many generic drugs and some IP related issues in a country. Umpteen number of such examples are available from India, Europe, United States and many other countries. Many would agree that in such cases, the core intent is as important as the issue.

I discussed on those hurdle creating campaigns in my article in this Blog, on August 25, 2014, titled, “Scandalizing Biosimilar Drugs With Safety Concerns”. Hence won’t dwell on that again here.

The campaign yielded results:

This campaign of global bio-pharma majors to restrict the entry of lower priced biosimilar drugs into the market, immediately after patent expiry, has been successful to a great extent, so far. Let me now give below a recent example, from credible sources, to vindicate this point.

Although, the world’s number 1 drug in sales – Humira (Adalimumab), with a turnover of US$ 15 Billion in 2015 (IMS Health), is going off patent in December 2016, no biosimilar version of Adalimumab is ready, just yet, to compete with this profit churning blockbuster biologic brand, in the United States. More interestingly, according to another report dated July 14, 2016 of the Wall Street Journal (WSJ), even on the verge of its product patent expiration this year, U.S. sales of Humira rose 32 percent to US$ 2.2 billion in the first quarter this year, with over 16 percent jump in its prescription volume.

It is worth noting, Humira was first approved in 2002, and has long been one of the most profitable drugs, globally, contributing around 60 percent of Abbvie’s total revenue even in the last year.

The industry may well argue, in a situation like this, how can a pharma company possibly decide to remain within the ambit of just patent protection, even if it leads to sacrificing other stakeholders’ interest? That’s a ‘business ethics’ issue, and is beyond the scope of this article.

The beginning of a yo-yo syndrome:

At the very outset, let me mention that the term ‘yo-yo syndrome’ has been coined to refer to something that moves up and down quickly, or something that changes repeatedly between one level and another.

Keeping this into perspective, some of the big bio-pharma companies, such as, Amgen, which have been, reportedly, trying hard to block the on-time entry of biosimilar drugs, through litigations and lobbying, could stand as good examples in this area.

For instance, Amgen, on the one hand, seem to be vigorously shielding its over US$10 billion of annual biologic sales from the biosimilar competition through powerful lobbying. Whereas, on the other, it commenced developing its own biosimilar drugs, to reap a rich harvest from the available opportunities.

According to an Associated Press report on July 12, 2016, a panel of Food and Drug Administration advisers of the United States has voted unanimously in favor of Amgen’s version of AbbVie’s Humira. While not binding, the recommendation could help the USFDA approval of the knockoff drug.

According to reports, the companies now working on Humira biosimilars, include Novartis, Mylan and Baxter.

India did it, but a tough road ahead:

On December 9, 2014, international media flashed across the world a great news item from the Indian pharma industry: “The first biosimilar of the world’s top-selling medicine Humira (adalimumab) of AbbVie has been launched in India by Zydus Cadila.” That said, let me hasten to add that Humira does not have a valid product patent protection in India.

Yet another good news is, according to a Press Release of Biocon dated July 15, 2016, its India made Insulin – Glargine was launched in Japan on the same day by its partner FUJIFILM Pharma Co., Ltd. (FFP).

These are excellent developments, and music to many ears. However, on the flip side, intense legal battle on various regulatory grounds against the Indian biosimilar drug players, by the makers of original biologic to protect their own turf of market monopoly, has also commenced with associated acrimony.

Earlier, the Swiss drug major – Roche had objected to Biocon’s referring to Herceptin at an international scientific conference, related to clinical trial results of its own ‘biosimilar’ version Herclon (trastuzumab).

On April 2016, responding to Roche’s complaint, the Delhi High Court ordered changes to the packaging labels of the brands sold by Biocon, and other bio-pharma companies in India, such as, Reliance Life Sciences and Mylan. The court also raised questions about the DCGI’s approval processes for biosimilars, and restrained the companies from using Roche’s data related to the manufacturing process, safety, efficacy and tests.  

More recently, this issue between Roche and Biocon, over breast cancer drug trastuzumab has reportedly taken another acrimonious turn with both the companies approaching the Delhi High Court on charges of contempt of court.

Roche reportedly also alleged contempt over Biocon using the name ‘Herceptin’ in the approval process of its trastuzumab drug in the United States. According to reports, Biocon is currently conducting Phase III clinical trials for marketing approval of its trastuzumab in the U.S.

Thus, to carve out a niche in the biosimilar space of the world, Indian pharma has made some good progress. Alongside, taking note of many contemporary factors and development in this area, a lurking apprehension too did creep in. It raises an awkward and uncomfortable question – do the Indian companies have pockets deep enough to overcome the expensive legal and regulatory challenges thrown by the global biologic drug makers to protect their market monopoly status for expensive drugs, much longer than what they deserve?

Let me keep my fingers crossed.

Critical global speed-bumps for biosimilar entry:

Besides, many other hurdles, as I highlighted in my article of August 25, 2014, the intricate patent shield beyond original patent expiry, is a major speed bump for biosimilar drugs’ smooth global market entry. 

Maintaining the same example of Humira, a well crafted patent-shield strategy was implemented to extend market monopoly of this brand, at least for another decade. Although, the main patent of Humira expires in December 2016, it is reportedly well shielded, at least, with 70 other patents till 2027, as many reports indicate.

This is possible because, according to a January 19 2016 report by Bloomberg, the U.S. patent office in the same month rejected Amgen’s effort to knock out two patents on AbbVie’s anti-inflammatory bestseller Humira. Amgen hoped to get its Humira competitor to market by 2017. This is a bad news for other biosimilar drug makers too.

Nevertheless, the good news is, in May 2016, the Patent Trial And Appeal Board (PTAB) announced that it would embark on a review of Coherus’ challenge of Humira’s ’135 methods patent. Experts believe, even if it the PTAB upturns Humira’s IP shield, AbbVie could appeal, which could take another year or so.

Recent status:

So far, after the biosimilar guidelines were put in place for the first time in the United States, a Novartis version of Amgen’s Neupogen, got USFDA approval in March 2015, only after so many delays and protracted litigations. Novartis is also trying to to do the same for Amgen’s Enbrel. Pfizer too won the U.S drug regulator’s approval in April 2016 for a version of Johnson & Johnson’s Remicade, but the product is still not available for sale.

Currently, some constituents of Big Pharma, such as, Amgen, Novartis and Pfizer have started warming up for manufacturing copycat versions of blockbuster original biologic drugs of other companies.

High quality biosimilars:

These new biosimilars are of top quality. Even USFDA could not find any meaningful differences in the key parameters, such as, efficacy, safety, potency and purity, between the original biologic drugs and their biosimilar versions.

According to a July 12, 2016 Bloomberg report, in several cases USFDA finds the clinical results of biosimilar drugs are robust enough to support ‘extrapolation’. This could support approval of these biosimilar drugs for all indications that the original biologic brands treat, without requirement of separate clinical trials for each, facilitating the approval process and accelerating their market entry.

With these developments, the high voltage lobbying campaigns of the original biologic makers, and their trade associations, both to the drug regulators and doctors, are expected to lose steam, if not ultimately die down altogether. 

However, the protracted and fierce legal battles of the originators, creating various intricate patent shields, to enjoy a brand monopoly for a much longer period, are expected to continue, if not turn fiercer.

The question of price advantage with biosimilars:

Currently the cost advantage provided by the biosimilar drugs over the original biologics, does not come anywhere near to what we see for small molecule generic drugs, post patent expiry. 

For example, Zarexio of Novartis has been priced 15 percent less than the original Neupogen of Amgen. It is generally believed that in the united states this difference would continue to be around 15 to 30 percent, in the near future. Whereas in Europe, the difference is higher, as the governments regulate their prices.

In India too, the difference in the pricing trend is currently, more or less, similar. 

Nonetheless, the above report of Bloomberg had quoted the global CEO of Novartis Joe Jimenez saying that biosimilar drugs would eventually cost 75 percent less than the original biologics. 

Let’s hope so.

Conclusion:

The powerful constituents of Big Pharma who decided to delay, if not stall the entry of biosimilar drugs for vested interest, have now started adopting a dual strategy. They did not have any other choice either, after President Obama’s fulfillment of his election promise with the ‘Affordable Care Act’, which, among others, facilitated charting the regulatory pathway for entry of biosimilar drugs in the United States, for the first time ever. 

Thus, on the one the one hand, these companies continued crafting robust patent-shields to extend market monopolies, even beyond the original patent expiries, through protracted and complicated litigations. While, on the other, started moving with great speed to develop biosimilar versions of the original blockbuster biologic drugs of other players, as they go off patent. This is mainly to cash-in the golden opportunities, which otherwise would go to different players.

India has made an entry into this space, but would still require a lot to do, including winning the expensive legal battles, in order to be recognized as a global force to reckon with, in the biosimilar segment.

To facilitate rapid growth, and universal acceptance of biosimilar drugs, for patients’ interest across the world, it will be interesting to follow the spread of the ‘yo-yo syndrome’ of the original biologic drug makers, as we move on.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Patented Drugs: A Dangerous Pricing Trend Impacting Patient Access

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The upcoming trend of jaw dropping high prices for new patented drugs sends a ‘storm signal’ to many stakeholders, especially for its adverse impact on patient access. Even more intriguing, such high and insane prices are being fixed rather arbitrarily, without any valid reason whatsoever. 

It has now been well established, very clearly, that this trend has no linkages with the necessity of keeping the wheel of cost-intensive new drug development initiatives moving, uninterruptedly.

Many believe that this dangerous inclination of the global pharma players picked up, in a major way, with the launch of sofosbuvir (Sovaldi), costing around US$ 1,000 per pill in the United States. This new drug has no relationship with Gilead’s own R&D initiatives, just as many other high priced patented drugs belonging to this genre.

Additionally, the current brand pricing strategy of even those pharma companies who are developing new drugs in-house, is equally intriguing, as those drug prices too have no direct or indirect relationship with R&D expenditures incurred by the respective players. As I discussed that issue in my Blog on August 18, 2014 in an article titled, “Patented Drug Pricing: Relevance To R&D Investments”, I am not arguing on those points here again.

Nevertheless, these unholy practices did not go unnoticed. Anguish against irresponsible pricing, adversely impacting patient access, started gaining momentum, all over. A raging debate has also kick-started on this issue within a wide spectrum of stakeholders, including various Governments and other payers.

They all are questioning, should the Governments, health insurance companies and other payers support such windfall profits of the so called ‘research based’ pharma companies’?

In this article, I shall deliberate on this issue, just when the voices of disgust against this unholy trend have started multiplying.

A palpable disgust expressed in a recent article: 

Against this arbitrary drug pricing trend, a good number of doctors have started raising their voices, with a discernible disgust. 

“We’re all paying a high price for drug company profiteering”, thundered Dr. Daniel J. Stone, an internal medicine and geriatric medicine specialist, in an Op-Ed published in ‘The Los Angeles Times’ on July 6, 2016. 

Dr. Stone further reiterated, “The drug companies are ripping us off, pill by pill, shot by shot. Instead of working to earn reasonable returns by relieving our suffering and saving lives, they now focus on profits above all. Their main targets are insurance companies. But when insurance companies take a hit, they bump up premiums to employers or the government. So we all pay - in taxes, reduced take-home pay, copayments and deductibles.”

Windfall profits:

The article focuses on this new trend in the global pharma industry, adversely affecting access to, especially, the new drugs to a vast majority of the patients. The author unambiguously highlighted that this dangerous pricing strategy got a major thrust from Gilead Sciences Inc. with its acquisition of sofosbuvir’s (Sovaldi) developer – ‘Pharmasset’ in 2011, for US$ 11 billion.

According to Dr. Stone, ‘Pharmasset’s chief executive made an estimated US$ 255 million on the deal, and its 82 employees each averaged around US$ 3.3 million, before Sovaldi came to the market. Thereafter, it’s a history. Gilead took a double markup on the drug, charging enough not just to more than cover the high cost of acquisition of ‘Pharmasset’, but also for making windfall profits.

The reason behind irresponsible pricing:     

The question, therefore, arises, how do the global pharma players dare to go for such irresponsible pricing in many countries of the world?

It is possible for them because the payers, especially the health insurance companies, usually find it difficult to out rightly ignore any unique and new life saving patented medicine for various reasons. As a result, the concerned companies, allegedly effectively use these payers, and also a large section of doctors who can prescribe these brands, facilitating them to make huge profits at the cost of patients.

The justification:

To justify such pricing, these pharma companies and their trade associations are apparently using fear as the key. Through various types of communications, they keep trying to convey that any attempt to restrict their so called ‘reasonable’ prices of these medicines would seriously jeopardize the innovative drug development process, jeopardizing the long term needs of the patients.

More recently, serious attempts were made to also establish Sovaldi’s so called ‘reasonable’ pricing, and its cost effectiveness, in an interesting way.

The company highlighted that Sovaldi is cost effective, not just in comparison to paying for other health care services that the drug might prevent, it also helps avoid cost intensive liver transplant, in many cases. With those costs not being incurred with Sovaldi, the patients, on the contrary, make some savings on the possible alternative treatment cost to fight this deadly disease.

Is it not an atrocious argument?

However, according to Dr. Stone, “This argument is a lot like a plumber billing a customer US$ 20,000 to fix a leaky pipe under the sink. Considering the costs of a possible flood, it might seem defensible. In the real world, any plumber charging based on ‘what you saved’ by preventing a potential catastrophe would lose business to competitors.”

A warning sign:

The above article also highlights, Sovaldi like drug price tag is an unmistakable warning sign, and the emerging trend of patented drug pricing system is a danger to the health of any nation. According to the author:

  • Reforming the financing of drug development will require more creativity.
  • The government should consider subsidizing research and development to reduce the industry’s risk, in return for oversight on pricing that would allow reasonable returns on investment. 

Not possible without many doctors’ active support:

Though it is encouraging to see that some doctors, such as, Daniel J. Stone are raising their voices and arguing against this practice, a large number of other doctors are being actively influenced by the pharma companies to prescribe such products.

This is vindicated by the latest release from the Open Payments database of the Government of the United States. It shows that the drug and device makers of the country incurred a mind boggling expenditure of US$ 2.6 billion towards payment to doctors related to speakers’ fees, meals, royalties and other payments, in 2015. Under the Physician Payments Sunshine Act of America, this is the second full year of the disclosure. 

The total payment made by the drug and device makers to doctors and medical institutions for the year was shown as US$ 7.52 billion.

The point to ponder:

That said, the question that surfaces, if Gilead had to sell its drugs to individuals incurring ‘out of pocket’ health expenditure, how many Sovaldi like drugs would it sell with equivalent to around US$ 80,000 treatments cost?

It won’t be too difficult to ferret out its answer, if we look at the countries, like India, with very high ‘out of pocket’ expenditure on health care, in general, and medicines in particular. 

A possible solution:

According to an article published by the World Health Organization (WHO) on February 8, 2007, Voluntary Licensing (VL)’ practices in the pharmaceutical sector could possibly be a solution to improving access to affordable medicines.

The Section 3 (d) of the Indian Patents 2005, which is generally applicable to ‘me too’ type of new products, could place India at an advantage. In the absence of a grant of evergreen type of product patents, many global companies would ultimately prefer to offer VL to Indian generic manufacturers, under specific terms and conditions, mainly to salvage the situation.

However, such a VL is unlikely to have any potential value, if the IPO refuses to grant patents to those products falling under the above section. In that case, generic competition would possibly further bring down the prices.

Has it started working in India?

Just to recapitulate, starting with a flash back to the year 2006, one can see that Gilead followed the VL strategy for India, probably for the first time, for its patented product tenofovir, used in the treatment of HIV/AIDS.

At that time Gilead announced that it is offering non-exclusive, voluntary licenses to generic manufacturers in India for the local Indian market, along with provision for those manufacturers to export tenofovir formulations to 97 other developing countries, as identified by Gilead. The company had signed a voluntary licensing agreement with Ranbaxy for tenofovir in 2006.

Interestingly, by that time Cipla had started selling one of the two versions of tenofovir, not licensed by Gilead. Cipla’s generic version was named Tenvir, available at a price of US$ 700 per person per year in India, against Gilead’s tenofovir (Viread) price of US$ 5,718 per patient per year in the developed Markets. Gilead’s target price for tenofovir in India was US$ 200 per month, as stated above.

Following this strategy, again in 2014, Gilead announced, “In line with the company’s past approach to its HIV medicines, the company will also offer to license production of this new drug to a number of rival low-cost Indian generic drug companies. They will be offered manufacturing know how and allowed to source and competitively price the product at whatever level they choose.”

Accordingly, on September 15, 2014, international media reported that Cipla, Ranbaxy, Strides Arcolab, Mylan, Cadila Healthcare, Hetero labs and Sequent Scientific are likely to sign in-licensing agreements with Gilead to sell low cost versions of Sovaldi in India. 

It was also announced, just as tenofovir, that these Indian generic manufacturers would be free to decide their own prices for sofosbuvir, ‘without any mandated floor price’.

Once again, in July 2016, it was reported that a drug called Epclusa – the latest breakthrough treatment for Hepatitis C virus could soon be available in India following Gilead Sciences’ getting its marketing approval from the US FDA.

Press Trust of India (PTI) reported, as part of its effort to offer affordable treatment, Gilead Sciences, together with its 11 partners in India, are pioneering a VL model that transfers technology and Intellectual Property for the latest treatments and cures for viral Hepatitis and HIV.

Some other pharma majors of the world also seem to be attempting to overcome the safeguards provided in the Indian Patents Act, which serves as the legal gatekeeper for the patients’ interest. Their strategy may not include VL, but also not so transparent ‘Patient Access Programs’, and the so called ‘flexible pricing’. All these mostly happen when the concerned companies sense that the product patents could fail to pass the scrutiny of the Indian Patents Act.

That said, I have not witnessed the global pharmaceutical companies’ issuing a flurry of VLs in India, as yet.

Another possible solution for India:

Another possible solution for India, although was scripted in Para 4. XV of the National Pharmaceutical Pricing Policy 2012 (NPPP 2012) and notified on December 07, 2012, unfortunately has not taken shape even after four years.

On ‘Pricing of Patented Drugs’, NPPA 2012 categorically states as follows:

“There is a separate committee constituted by the Government Order dated February 01, 2007 for finalizing the pricing of Patented Drugs, and decisions on pricing of patented Drugs would be based on the recommendation of this committee.”

To utter disappointment of many, a strong will to make it happen, even by the new Government is still eluding, by far.

Conclusion:

Without having adequate access to new life-saving drugs, the struggle for life in the fierce battle against dangerous ailments, has indeed assumed an alarming dimension. This is being fuelled by the absence of Universal Health Coverage, and ‘out of pocket expenditure’ on medicines in India being one of the highest in the world.

It would continue to remain so, up until the global pharma majors consider entering into a VL agreement with the Indian pharma majors, just as Gilead. Otherwise, the Government in power should demonstrate its strong will to act, putting in place a transparent model of ‘patented drugs pricing’, without succumbing to any power play or pressures of any kind from vested interests.

Sans these strong initiatives, the dangerous trend of patented drug pricing will continue to deny access of many new medicines to a vast majority of the population to save precious lives.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Leveraging 3D Printing In Pharma, For Cost Containment And Patient-Centricity

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Today, although a number of new and state of the art drugs is regularly being developed, and brought to the market at a reasonably rapid pace, their access to the majority of the global population has still remained a huge challenge. One of the key access barriers continue to remain exorbitant prices of these drugs.   

Keeping commensurate pace with gradual improvement in the pinpointed diagnosis of various diseases with modern diagnostics, processes, devices and techniques, fueled by increasing health awareness within a sizeable section of the population, more patients are now aspiring for access to a better quality of life, and greater productivity at work. This is happening all over the world, though with varying degree and magnitude. 

Consequently, there has been a sharp increase in the demand for healthcare, which has caused a huge bottleneck in the overall healthcare delivery process, for various reasons. The huge gap between the availability of high-tech drugs/healthcare services, and their access to the general population, mostly due to affordability reasons, is going north at a rapid pace. 

Two-pronged cost containment pressure:

This unfettered ascending trend is creating primarily the following two types of cost containment pressure: 

  • Being driven purely by the economical reasons, the Governments and other payers have started taking stringent cost-containment measures, bringing huge pricing pressure, especially on the drugs and medical device manufacturers.
  • In countries, such as, India, where the ‘Out of Pocket’ expenditure on healthcare in general, and the medicines in particular, is hovering around 70 percent, the patients, several Governments have started announcing drug price control policy to protect the health interest of patients. 

However, currently, only some piecemeal measures are being initiated, including in India, where a holistic approach for all, such as, Universal Health Care (UHC) and several other similar options, are long overdue.

Three different remedial measures:

In my view, consideration of either of these three following approaches, or an innovative blend of these, would enable the Governments to address this pressing issue, remove the existing bottle neck, and thereby bridge the healthcare access gap, holistically:

A. Fast implementation of Universal Health Care (UHC).

B. Closer look at the entire Pharmaceutical Value Chain with a resolve to work out innovative, game-changing solutions to reduce cost of each of its critical components, significantly.

C. Effectively addressing the emerging need of Patient-Centricity.

A. Fast implementation of Universal Health Care (UHC):  

I have already discussed UHC in one of my articles titled, “Universal Health Coverage: The Only Alternative To Drug Price Control in India?”, published in this Blog on November 9, 2015.

B. Cost containment with 3D printing:

A report of IMS Health, published on November 18, 2015, forecasts the increase of  total global spend for pharmaceuticals by US$ 349 billion on a constant-dollar basis, compared with US$182 billion during the past five years. It also indicated, more than half of the world’s population will live in countries where the use of medicine will exceed one dose per person per day by 2020, up from 31 percent in 2005, as the “medicine use gap” between the developed and the emerging markets narrows. 

This steep ascending trend would eventually affect the pharma ‘Value Chain’ in a significant way, throwing open several path-breaking high-technology based options, with impressive favorable impact on the general costs of medicines. 3D-printing technology is expected to play a significant role in this initiative.

Before proceeding further, let me zero-in on a few critical components, as follows, of the pharma ‘Value Chain’, as I see visualize these: 

  • Drug innovation (R&D)
  • Manufacturing
  • Marketing
  • Supply Chain

According to my understanding, at least in 3 of the above 4 ‘Value Chain’ components, there is an immense potential of leveraging 3D printing technology effectively, and in a big way.

In my article of January 11, 2016, published in this Blog, titled “3D Printing: An Emerging Game Changer in Pharma  Business”, I have already discussed the game changing impact of 3D Printing technology on the drug discovery process, drug manufacturing strategy, and supply Chain effectiveness in the pharma business. 

Hence, I prefer not to dwell on those areas, yet again, here. Instead, I shall briefly deliberate on the application of 3D Printing technology to effectively address the emerging need of ‘Patient-Centricity’ with an interesting and a very recent example. 

C. Improving ‘Patient-Centricity’ with 3D printing: 

At this stage, there is a need to understand what exactly is the ‘’Patient-Centricity’. It seems to be a popular buzzword now with the health care related companies, primarily to give an impression that they are really focusing on ‘Patient-Centricity’.

However, there does not seem to exist any universally accepted definition of this terminology, just yet. Nevertheless, one appropriate definition could well be: “A focused and transparent approach to providing maximum possible benefits to a patient from a drug, device, technology, or health care services.” 

I briefly focused on a part of this basic issue in my article titled, “‘Disease Oriented Treatment’ to ‘Patient Oriented Treatment’- An evolving trend’, published in this Blog on January 7, 2013.

As I said before, in this article, to explain ‘Patient-Centric’ approaches with 3D printing, I would quote from a very recent, and a path-breaking work in this area.

On May 25, 2016, ‘The Straits Times’ reported, the researchers at the National University of Singapore have found a way to use 3D printers to create low-cost tablets. With the help of this technology a tablet can be so personalized to respond to individual patient’s needs that the drug can be customized to take on different release profiles, such as, constant release, pulsed release, increasing or decreasing release, and any arbitrary interval as required by the patient. However, the most striking is, different drugs with different release profiles can also be combined in a single pill.

Once administered, the tablet dissolves layer by layer over a period of time, releasing the drug at a controlled rate. The duration can be altered by changing the chemical composition of the liquid.

It is worth noting here that the conventional tablets are only capable of a constant rate of release, requiring the patient to manually control the dosage and release rate, by taking doses according to a prescribed schedule, given by the doctor. In this scenario, if a patient requires different drugs with different dosages and intervals, it can become inconvenient to keep track and potentially dangerous, especially when the patient misses a dose, the report highlighted. 

The commercially available printer used in the project costs just S$2,000.

The Assistant Professor Soh Siow Ling, who leads the project, reportedly, expects that the low cost will allow it to be used in hospitals and neighborhood clinics. He further explained, “Every single person is different, based on many factors such as genetics, age, body mass and so on. Different people also have different activity levels and consumption habits, which affect their needs. It is, (therefore), not desirable to use the same drug to treat different illnesses which have similar apparent symptoms.”

The report indicated that in October, 2015, these findings were published in an issue of Advanced Materials, which is a peer-reviewed materials science journal.

A patent for the tablets was filed last year, and they are currently in talks with multinational corporations, and medical professionals to identify potential applications, the article highlighted. 

Changing role of doctors:

From the above developments, it appears that unleashing the full potential of 3D printing technology in the pharma industry, would also enable the medical profession to move further towards ‘Patient-Centricity’, in its true sense.

This technology would empower them offering to each patient, the right drug or drug combinations, with most suitable drug delivery system, and exactly the way individual patients would prefer, with a very high degree of precision.

Thus, from overall disease treatment perspective, especially with medicines, this approach offers a great potential to be significantly more effective, and convenient to individual patients, as compared to the conventional approaches. 

I reckon, over a period of time, professional competitiveness would drive the doctors further honing their effectiveness in the disease treatment process, and that too with a high degree of precision. In that situation, many doctors may decide to setup on-demand 3D drug-printing facilities even at their clinics.

The gradual embodiment of this brilliant technology by the doctors, is expected to throw open new vistas of opportunity, also to personalize the shapes, colors and flavors of any medicine, according to individual patient’s choice. This, in turn, would improve patient compliance, ensure a predictable relief from the disease, and demonstrate ‘Patient-Centricity’ of a high order by the medical profession, in general. 

Conclusion:

For the first time ever, with Aprecia Pharmaceuticals in the United States getting approval of the US-FDA on August 3, 2015 for the market launch of a 3D printed prescription drug for oral use by the epilepsy patients, dawns a new paradigm in the global pharma business horizon.

Effective application of this ‘disruptive innovation’ could well be a game changer not just in the ‘value chain’ of conventional pharma business models, across the world, but also for taking a giant leap towards ‘Patient-Centricity’. The doctors are also expected to be very much an integral part of this process. 

Besides all the above benefits, 3D printing can also encourage low-volume production, whenever required, and a wide variety of Active Pharmaceutical Ingredients, to meet any immediate demand, mostly for use in research and developmental work. 

Thus, noting the ongoing significant progress in this area, I reckon, leveraging 3D printing technology in pharma, not just to address the cost containment pressure, effectively, but also to ensure a tangible and visible move towards ‘Patient-Centricity’, in true sense. All-round success in the innovative application of this cutting-edge technology in the global pharma industry, would eventually separate men from boys in pursuit of business excellence. 

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

The Next Frontier: Frugal Innovation For High-Tech Drugs

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Should drug innovation models remain as expensive as what these are claimed to be now by the global pharma industry, in general?

Finding a credible, appropriately quantifiable, and generally acceptable answer to this question is critical. It won’t, then, just be a myth-buster for billions of dollar price tag, that is now being attached to drug innovation and development initiatives, by the global pharma industry, as a justification for arbitrarily fixing high new drug prices. If the upcoming and new startups with frugal models for even high-tech drug innovation succeed with flying colors, the patients and the payers would also possibly breathe a huge sigh of relief, from the increasing burden of disease and the cost of medicines.

I believe, it would eventually happen, may not be overnight, but over a period of time. I shall discuss in this article about some bright sparks, already visible in that direction.

The facade of high cost of drug innovation: 

At the very outset, to avoid any possibility of misunderstanding, let me confess up front, just as many others, I also strongly believe that drug innovation is extremely important. It needs to be encouraged, protected and rewarded reasonably.

That said, let me also give the right perspective of how the cost of ‘drug innovation’ is being often misused as a facade for keeping the drug prices high, if not exorbitant.

According to a contentious study of ‘Tufts University Center for the Study of Drug Development’, the total cost of innovation of a new drug and bringing it to market, has increased more than double from US$ 1.22 billion in 2003 to US$ 2.6 billion in 2014. 

Despite these numbers being vehemently challenged in credible journals, many global pharma majors still keep justifying the high new drug prices on the same old pretext. As a diversionary tactic, they relentlessly argue that innovation has to be adequately rewarded to keep its wheels moving in perpetuity, though no one challenges this basic fact, not even remotely.

The moot questions:

The moot questions, therefore, are: how expensive is the drug innovation and how does the global drug industry establish its relationship with high new drug prices? The answers to these queries must be clear, specific, quantifiable and credible, and not ethereal, if not airy-fairy.

In this context, my article titled, “How Expensive Is Drug Innovation?” found an echo in a globally reputed journal. An analysis published in the BMJ in May 2016 titled, “Propaganda or the cost of innovation? Challenging the high price of new drugs”, expressed deep concern on the rising prices of new medicines. It reiterated that this trend is set to overwhelm health systems around the world.

The above BMJ article also put forth similar questions: “What does it really cost to bring a new medicine to the market, and do these costs justify the high price?”

The authors pointed out that the pharmaceutical market is not actually a “free market” based on supply and demand with minimal government intervention through taxes, subsidies, or regulation. On the contrary, the pharma market is highly manipulated, and not focused on achieving the best prices, or even fair prices for essential and life saving medicines. 

No linear link between high drug price and innovation cost: 

As I discussed this subject in my previous article titled, “Arbitrary Pricing of Essential Drugs Invites State Intervention”, it has been well established by now that there is no linear, or any relationship between high drug prices and cost of drug innovation.  Since long, this argument is being misused just as a façade to keep the cost of medicines high, and making high profits even at the cost of lower sales volume.

The façade has started crumbling:

In India too, the pharma MNCs often use the same façade to keep the prices of also their branded generics much higher than the comparable formulations manufactured by larger domestic pharma manufacturers. However, the façade has started crumbling in many countries, across the world. This gradually increasing general realization is welcoming. 

The Governments in many countries, have now started acting. They are increasingly forcing the drug makers to eye for volume growth, by reducing the fat margin, and improving patients’ access to high-priced drugs.

Just to draw an example, I would quote a very recent development in this area, outside India. On May 20, 2016, the Chinese health authorities announced price cuts of up to two-thirds to three patented drugs, in their latest move to reduce the cost of healthcare for patients. It is noteworthy that this happened in the world’s second-biggest economy, after the United States.

Why is arbitrary drug pricing continuing?

It appears, the only reason for the majority of the drug players to continue keeping the new drug prices high is because they can still make huge money through a small segment of patients who can afford their brands. What about the rest? This doesn’t seem to matter to them, at all, unless compelled to, in various ways.

Need to totally demolish the façade of innovation:

Thus, there is a compelling need is to demolish the façade of innovation, decisively, for keeping medicine prices high.

To move towards this direction, some flickers of a sound possibilities, are now visible in the horizon. The ‘Frugal’ or the ‘Silicon Valley’ type startups for high-tech drug innovation models, especially in the biotech sector, have shown high potential to be a game changer in this area.                                                                

Frugal innovation models for high-tech drugs:

The quest to find a pathway towards this direction continues. Recently, Professor Atul Butte, Director of the University of California Institute of Computational Health Sciences, highlighted that like other Silicon Valley startups, almost anyone can bring a drug to market from their garage with just a computer, the internet, and freely available data. Professor Butte, students, and research staff have already explored various methods and approaches of scientifically utilizing this data in search for new medicines. 

As reported in the May 5, 2016 issue of ‘The Conversation’, Professor Butte outlined this process for an audience of local and international scientists and medics in a talk given at the Science on the Swan conference held in Perth in May 2016.

Professor Butte outlined several models of ‘Frugal Innovation’, especially for new biotech drugs or finding new indications for existing drugs.

A. The search for a new target:

There could be several approaches to the search of a new biotech drug. An example of one such, that Butte’s team is reportedly engaged in, is the construction of a map of how the genetic profiles of people with particular diseases are related to each other. The team looked for diseases with very similar genetic profiles.

Some may argue, this process of discovering other uses of drugs, conventionally termed as “drug repositioning”, is in the strictest sense is not exactly a novel one. They may attempt to establish it by drawing an example from Viagra, which was originally developed for treatment of cardiovascular conditions. However, the major difference is that Viagra’s repositioning for erectile dysfunction is an outcome triggered by its side-effects in patients taking the drug for its original cardiovascular disease treatment. 

B. Desk research and discovery:

The primary desk research can start from the freely available enormous published genetic data, based on thousands of studies on humans, mice and other animals. The publications’ websites are also highly credible, such as, National Institute of Health and the European Molecular Biology Laboratory. Thus, as a result of abundantly available high quality genetic data, the cost of genetic sequencing, using gene chip technologies, is also coming down quite rapidly.                                                                                                 

C. Animal testing:

After the potential drug discovery in the garage, there is a need to test the drugs on animals. 

As Professor Butte suggests, this process also can be made much less expensive. For this purpose, he recommends the internet and the websites, such as, Assay Depot. This site is structured like Amazon, from which a researcher can order an experiment to be carried out to test a drug on a range of animal models, as the report states.

Butte finds this Internet based process very useful for ‘choosing the experiment type the researcher wants, adding it to a shopping cart, paying by credit card and getting the experimental results mailed back in a few weeks’ time.’ Such websites also offer wide choices to the researchers, even regarding the laboratory they would like to use, including the country where the laboratory is located. 

D. Human Trial:

As ‘The Conversation’ article indicates, once a new use for a drug has been shown to work in an animal model, the next step would be to test the drug on human volunteers, get approval for the use of the drug for that condition, and then finally take the drug to market.

This purpose could involve spinning out startups with money from investors. In California, Professor Butte and his students have already followed this process after discovery of new uses for several drugs.

As Professor Butte epitomizes, none of this would be possible without sharing data. The ‘Frugal innovation’ models also highlight, how the growth of availability of open research data will be able to discover a range of uses, that would not have been foreseen, when the individual experiments were being carried out.

Would Big Pharma gobble up these startups?

If ‘Big Pharma’ starts gobbling up these startups paying exorbitant prices, the expectations of lower prices of novel drugs may possibly not come to fruition. Nevertheless, the facade of innovation for high drug prices would crumble. But, surely some other different and well-orchestrated pretext would surface, to maintain their stubbornness to continue with the same business model of very high margin and lesser volume sales, with cash register ringing, as ever.

Here is an example. ‘The Huffington Post’, in an article of May 10, 2016, reported on Big Pharma’s betting on a cancer drug startup.                                                 

The May 2016 article said, the pharmaceutical giant AbbVie acquired a startup named ‘Stemcentrx’ in a deal that values it at as high as US$10 billion.

The startup Stemcentrx has found out a unique approach, though somewhat controversial, for treating several forms of cancer. While most of today’s treatments view cancer as a result of unchecked cell growth, wherein any cell is capable of becoming cancerous, Stemcentrx believes that cancer primarily sprouts from only one cell type: cancer stem cells.

Conclusion:

Be that as it may, hopefully, the evolving models of ‘Frugal innovation’, development and commercialization of high-tech drugs, are expected to be the game changer for quickly bringing a number of new drugs, or existing drugs for new indications to the market, for many disease conditions, at very affordable cost.

Big Pharma may not allow it happen so easily, just for vested interest, but the pressure group must keep a close vigil on this development, and more importantly, must prevail.

Thus, the next frontier of pharma research and development, would possibly shift to small startups of ‘Frugal Innovation’, especially for affordable high-tech drugs, extending their access to the majority of the patients, the world over. 

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Arbitrary Pricing of Essential Drugs Invites State Intervention

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Arbitrary drug pricing has now become a subject of a raging debate, all over the globe. It involves both patented and generic drugs, as we have recently witnessed in the largest pharma market in the world – the United States.

In many countries the same issue is inviting the direct intervention of the Government to protect health interest of a vast majority of the populations. India, I reckon, belongs to this group of countries. 

In this article, I shall discuss this issue, citing examples from both the global and local recent developments.

Most high drug price increases defy logic: 

Published in March 2016, the ‘Express Scripts 2015 Drug Trend Report’ points out, in the perspective of the United States, that over the last 30 years more and more dollars are spent on specialty, rather than on traditional medications.

Most drug development and spend in the late ‘80s and early ‘90s, used to be on traditional, mostly small-molecule oral solid drugs, used to treat conditions, such as, peptic ulcer, depression, hypertension and diabetes. Today, 37.7 percent of drug spends go for specialty medications, with the number expected to increase to 50 percent by 2018, and continue to grow further, thereafter. 

The report also states that there are 7,000 potential drugs in development, with most aimed at treating the high-use categories of oncology, neurologic disorders and infectious diseases.

High-cost therapies for non-orphan conditions, particularly for cancer, high cholesterol and Alzheimer’s disease, will continue to increase the population of patients with high annual drug expenditures.

‘Express Scripts Exclusive Prescription Price Index’ reveals a brand-price inflation in the United States, nearly doubled between 2011 and 2015, with the greatest impact seen in more recent years. Compared to 2014, brand prices in 2015 were 16 percent higher. Brand medications have increased in price by 164 percent between 2008 and 2015, the report highlighted.

Similar trend, though may not be of similar magnitude and proportion, has commenced in India too. In this emerging situation, the patients with high ‘out of pocket’ expenditure on medicines have started feeling the pinch too. This is becoming more intense as the disease pattern has started shifting from short-term infectious and parasitic diseases to almost lifelong non-infectious chronic ailments.

The pressure started building up:

The drug industry is likely to come under increasing scrutiny on product pricing, to alleviate the ‘pressure cooker’ situation for the patients, in general, especially during chronic and life-threatening disease conditions. 

May 10, 2016 issue of ‘Bloomberg’, in an article titled, “Mutual Fund Industry to Drug makers: Stand Up and Defend Yourself”, reported: “In a sign of how U.S. political pressure to rein in drug pricing is weighing on pharmaceutical companies and their investors, a group of major funds called an unusual meeting with top biotech and pharma lobbyists, urging them to do a better job defending their industry.” This is indeed unusual, and I reckon, should happen in India too. 

The article also states: “Investors are stepping up pressure on pharma lobbyists at a critical time for the industry, as drug pricing has become a potent political issue on the presidential campaign trail and in Congress. Democratic candidate Hillary Clinton sent biotech stocks tumbling last year when she first talked about ‘price gouging,’ and Donald Trump has suggested that Medicare should negotiate with manufacturers.”  

It also reported that responding to this emerging pressure situation, the global pharmaceutical lobbying organizations, such as, PhRMA in the Washington, DC has already set up a dedicated webpage called “Costs in Context” with infographics and fact sheets. It has also tried to peg responsibility on insurance companies for making it hard for patients to access medicines. 

Patients’ can no longer be taken for granted:

That patients’ can no longer be taken for granted with costly drugs, backed by high profile marketing campaigns, is evident from a recent study.

In May 2016, Harvard T.H. Chan School of Public Health, published a poll result on “Americans’ Attitudes About Changing Current Prescription Drug & Medical Device Regulation”. 

Among many other related issues, the study reflected that around 57 percent of the poll participants believe that pharmaceutical companies should no longer be allowed to advertise prescription drugs on television. This is because of interesting reasons. The respondents believe that ads for prescription medicines sometimes encourage and persuade the patients to ask for costlier drugs that may not be appropriate for them. 

In this context, it is worth recapitulating that on November 17, 2015 the American Medical Association (AMA) also called for a ban on direct-to-consumer advertising of prescription drugs and medical devices, including television advertisements. 

According to a statement released by the group, “member physicians are concerned about a growing proliferation of ads driving demand for expensive treatments, despite the clinical effectiveness of less costly alternatives.” 

Hence, the bottom-line is, even the American patients, most of whom are covered by health insurance of different kinds, are now feeling the bite of increasing medicine prices.

Many patients seem to be realizing that such unfair price increases, driven by the respective pharma manufacturers, are avoidable. This serious concern may assume a snowballing effect, notwithstanding high voltage lobbying and campaigns to negate these general stakeholders’ feelings by the top global pharma lobbying organizations, across the world, India included.

Premium pricing of MNCs’ branded generics arbitrary?

One gets its reflection even in the Indian branded generic market, where the MNCs usually market their generic single molecule or FDC brands at a huge premium price. Such high priced products are backed by intense marketing of all kinds. The MNCs’ justification of charging a high premium stand on the promise of adherence to world-class drug quality standards, unlike many domestic generic manufacturers.

There are not enough evidences either to accept or ignore this claim. However, it has received a big jolt even recently, raising similar suspicion as I briefly raised in my article titled, “Ease of Doing Pharma Business in India: A Kaleidoscopic View”, published in this blog on March 28, 2016. 

On May 12, 2016 Reuters reported that Central Drugs Standard Control Organization (CDSCO) of India, in the notices posted on its website in February and also in April, has made it public that it has found some batches of Sanofi’s ‘Combiflam’ (FDC of paracetamol and ibuprofen) to be “not of standard quality”, as they failed disintegration tests. 

According to the US-FDA, this particular test is used as an integral part of quality-assurance measure in pharmaceuticals, and its non-conformance makes the drug ‘sub-standard’. 

Hence, huge premium charged for all those branded generics, which are outside DPCO, and mostly by the MNCs, may be construed by many as baseless and arbitrary.

Premium pricing, with payment to doctors is a winner?

This has again been vindicated in a recent study.

A paper, published in the May 09, 2016 issue of JAMA Internal Medicine, establishes that: ‘Pharmaceutical industry payments to physicians may affect prescribing practices and increase costs, if more expensive medications are prescribed.’

Although no such credible study has been published in the Indian context, it is widely believed, the prevailing situation in this regard, within the country, is no different. Nevertheless, arbitrarily high drug pricing, even for the branded generics, is considered as a winning strategy by many pharma companies. 

When the Government steps in:

It happened in India recently, yet again.

As we know, the ‘National List of Essential Medicines 2011 (NLEM 2011)’ came under intense public criticism, as it did not include many modern drugs for chronic and lifesaving diseases under its fold, for inclusion in the drug price control order of the Government.

The Experts Committee formed for this purpose recommended addition of a number of drugs for a variety of serious diseases, such as, cancer, hepatitis C, diabetes, cardiovascular, and HIV in the NLEM, to make them more affordable to patients. 

Acting on this proposal, the Union Ministry of Health replaced the NLEM 2011 by NLEM 2015 in December 2015. This increased the span of drug price control from 684 to 875 medicines.

According to the well-reputed pharma market research organization – AIOCD Pharmasofttech AWACS Pvt Ltd., with NLEM 2015, still only 18 percent of Indian Pharmaceutical Market (IPM) by value will now come under price control, against 17 percent with NLEM 2011. 

On May 12, 2016 the ‘National Pharmaceutical Pricing Authority (NPPA)’ started with revising prices of 54 recently included essential medicines in the NLEM 2015, in some cases bringing them down up to 55 percent, in conformance with the DPCO. Again on May 19, 2016 another set of 27 formulations,  which, among others, include the treatment for epilepsy, infections and diabetes, were brought under price control.

Does ‘free market economy’ work in pharma industry?

As the NPPA has articulated a number of times, with umpteen number of examples, that arbitrary and wide variation in pricing for the same kind of branded generics is a result of ‘market failure’.

We all are living in a unique situation, where the consumers are unable to participate in the process of an affordable drug selection, much unlike any other consumer goods in a ‘free economy’. 

I deliberated this issue in my article titled, “Does ‘Free-Market Economy’ Work For Branded Generic Drugs In India?”, published in this Blog on April 27, 2015.

Conclusion: 

Arbitrary drug pricing is increasingly attracting the ire of many Governments, other payers, patients and even some important investors, as we have seen in the United States. Most Indian fund houses and other investors are probably taking stock of the possible emerging situation. A large number of them are, by and large, going by the same old and traditional way of evaluating a pharma business.                                                                                 

Pharma companies, across the world, instead of trying to find out an innovative way to douse this fire for the benefit of all concerned, are getting more and more desperate to rationalize their arbitrary drug pricing, in whatever way they possibly can.

The approach taken by them is convincing none, instead, adding further fuel to the fire. Getting favorable views from some handful of seemingly spoon-fed write-ups, would possibly not help resolve this raging issue or protect public health interest, in any way. 

All concerned should try to realize that a utopian ‘free market economy for medicines’, with patients exercising their informed choices, backed by active support from the treating doctor, does not exist in the real world, not just yet. 

Thus, arbitrary pricing for essential drugs, where market competition is made irrelevant by many drug makers, allegedly by unethically influencing the prescribers in various ways, merits state intervention, unquestionably, solely to protect patients’ health interest.

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.