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Marketing Off-label Use of Drugs: A Path Much Abused?

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As many would know, prescribing any medicine for disease conditions that are not approved by the drug approving authorities while granting its marketing approval, is generally termed as ‘off-label’ use of drugs.

It is also a usual practice in most of the regulated markets of the world that once the drug regulators give marketing approval of a medicine, which is indication-specific, physicians are free to prescribe these as they deem necessary. However, the drug manufacturers can seek prescription support from the doctors only for the indications as approved by the appropriate government authorities.

Even the USFDA had articulated, “the best way to address any concerns that the information about those (off-label) uses is not reaching medical practitioners is to get those uses in the labeling. We believe that the risks of allowing drug companies to distribute journal articles and other information about off label uses far outweigh any benefits.”        

Since long, most of the drug regulators across the world, including the Drug Controller General of India (DCGI) have prohibited the sales promotion for unapproved uses of drugs to doctors. Nevertheless, the practice continues ignoring its serious consequences.

Monitoring of ‘off-label’ use is challenging: 

Monitoring of off-label use of medicines is quite challenging too by the drug regulators, especially in India, where post marketing surveillance is generally just on paper.

In this regard, a recent research study that I shall refer to below in this article, has quite appropriately suggested, “Future electronic health records should be designed to enable post market surveillance of treatment indications and treatment outcomes to monitor the safety of on and off-label uses of drugs.”

As India intends to move towards the ‘Digital’ space, this suggestion would be quite implementable by the DCGI, as the ‘Smart Cities’ start coming up.

Some examples of extensive off-label usages: 

According to the study done by a team of experts in medical information – Iodine, using the top drugs by number of monthly prescriptions, the following is a list of 4 medications with surprising off-label uses:

Drug Approved Indication Off-label Indication
Abilify (Aripiprazole) Schizophrenia, Bipolar Disorder, Major Depressive Disorder (adjunctive), Autism-related Irritability, Agitation associated with Schizophrenia or Bipolar Mania, other Insomnia
Lyrica (Pregabalin) Management of: neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, fibromyalgia, neuropathic pain associated with spinal cord injury; adult patients with partial onset seizures (adjunctive) Anxiety
Namenda (Memantine) Moderate to severe dementia of the Alzheimer’s type ADHD, OCD
Synthroid (Levothyroxine) Low thyroid hormone levels, some types of goiters, management some types of thyroid cancers Depression

Off-label use and increasing risks of drug safety: 

In its November 02, 2015 online issue, JAMA Internal Medicine published an article titled, “Association of Off-Label Drug Use and Adverse Drug Events (ADE) in an Adult Population.” The objective of this study was to monitor and evaluate off-label use of prescription drugs and its effect on ADEs in an adult population.

This particular study assumes importance, as off-label use of prescription drugs without strong scientific evidence has been identified as an important contributor to preventable Adverse Drug Events (ADEs), especially in children. However, despite concerns in this regard, no systematic investigation on the effects of off-label drug use in adult populations is being performed, regularly.

The detail analysis of this study reveals that not only is the benefit of off-label prescription is uncertain, but the risks of ADEs could make the ‘risk-benefit ratio’ quite unfavorable. So much so that in a large number of cases, no drug treatment will be a much better option.

According to the authors, the risk for ADEs grew as the number of prescription drugs the patient used increased. For example, patients using eight or more drugs had more than a 5-fold increased risk for ADEs compared with patients who used one to two drugs.

The study involving 46,021 adult patients, receiving 151,305 prescriptions between January 2005 and December 2009 was done in Canada. Of those prescriptions, more than 10 percent were prescribed for off-label use. Interestingly, out of that group, more than 80 percent prescriptions were for off-label uses without any robust scientific evidence supporting the use.

Based on the findings the researchers concluded that off-label use of prescription drugs is associated with ADEs.

The article suggested:

  • Caution should be exercised in prescribing drugs for off-label uses that lack strong scientific evidence.
  • Future electronic health records should be designed to enable post market surveillance of treatment indications and treatment outcomes to monitor the safety of on and off-label uses of drugs.

Pharma industry strongly opposes off-label use, when it suits them:

Interestingly, pharma industry vehemently opposes off-label use of drugs, when it suits them.

To give just a couple of examples, recently a new law that permits prescribing of drugs for off-label uses in France has reportedly been strongly opposed by the pharmaceutical industry in Europe.

Pharma trade associations argue, “the above move of France is directly in opposition to European Union’s laws that prohibit member states from supporting off-label use for economic purposes, and is a trend that undermines the current regulatory framework and could put patients’ health at risk.”

Besides France, they have also submitted a complaint against Italy to the European Commission over the country’s new off-label rules.

Common methods followed for off-label marketing:

The other side of the story is that, reportedly many pharma companies continue promoting off-label uses of drugs aggressively, for significant commercial gains.

According to ‘The Centers for Medicare & Medicaid Services (CMS) – a federal agency within the United States Department of Health and Human Services, some of the off-label drug promotion methods of the pharmaceutical companies are as follows:

• Paying incentives to sales representatives based on sales for off-label use

• Paying kickbacks to physicians to prescribe drugs for off-label use

• Disseminating misleading posters promoting off-label use

• Paying physicians:

- To pretend to be the authors of articles about off-label uses when the articles were actually written by manufacturers’ agents

- To serve as members of “advisory boards” promoting off-label use

- To travel to resort locations to listen to promotions about off-label use

- To give promotional lectures in favor of off-label use to fellow practitioners

• Publicizing studies showing efficacy of off-label uses, while suppressing studies showing no efficacy.

Even the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) of the Government of India does not allow such sales and marketing practices. But these all continue to happen, unabatedly.

A path much abused?

Although most of the drug companies publicly advocate self regulation to avoid unethical marketing practices, the situation on the ground is much different, across the world. 

The following are just a few examples of serious business consequences faced by some of the well-known global pharma and biotech majors, besides many others, from the United States Department of Justice, for alleged off-label promotion of drugs: 

  • On November 4, 2013, Johnson & Johnson (J&J) was asked to pay more than US$ 2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promoting for uses not approved as safe and effective by the USFDA and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  
  • On July 30, 2013, Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer, Inc. in 2009, agreed to pay US$490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the USFDA. 
  • On December 19, 2012, Amgen Inc. pleaded guilty and paid US$762 million to resolve criminal liability and false claims allegations.
  • On July 2, 2012 GlaxoSmithKline LLC (GSK) pleaded guilty and paid US$3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices. This resolution is the largest health care fraud settlement in the US history and the largest payment ever by a drug company, so far. 
  • On May 7, 2012, Abbott Laboratories Inc. pleaded guilty and agreed to pay US$1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the USFDA.  This resolution is the second largest payment by a drug company and includes a criminal fine and forfeiture totaling US$700 million and civil settlements with the federal government and the states totaling US$800 million.  Abbott also was reportedly subjected to court-supervised probation and reporting obligations for Abbott’s CEO and Board of Directors.
  • On October 21, 2011, Pfizer Inc. agreed to pay US$14.5 million to resolve false claims allegations related to its marketing of the drug Detrol. 
  • On June 10, 2011, Novo Nordisk was asked to pay US$25 million to resolve allegations of off-label promotion of Novoseven.
  • On September 30, 2010, Novartis agreed to pay US$422.5 million to settle criminal and civil investigations into the marketing of the anti-seizure medicine Trileptal and five other drugs. The government accused Novartis of mislabeling, paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. 

Hence, it appears that the path followed by many pharma players to inform the doctors about the judicious off-label use of drugs only in circumstances where approved treatments have failed, is being much abused. 

A conflict of interest? 

Many doctors believe that there is also a distinct upside for off-label use of drugs, as flexibility of a physician to prescribe drugs off-label offers important advantages too, especially in circumstances where approved treatments have failed. This is indeed true and indisputable.

However, the reality is, many pharma industry, in general, actively encourage off-label use of drugs for commercial benefits through expanded use of their respective brands.

Aggressive drug promotion for various off-label uses, reportedly being so widespread and indiscriminate, many physicians can’t even remember the approved indications of drugs. Hence, they do not necessarily go for off-label use only when approved treatments have failed.  In this context, on November 23, 2015, ‘The Wall Street Journal (WSJ)’ in an article titled, “Risk of Off-Label Uses for Prescription Drugs” reported as follows:

“A 2009 study published in the journal Pharmacoepidemiology and Drug Safety found that 1,199 physicians in a national survey were able to identify the FDA-approved indication of 22 drugs only about 55% of the time. The physicians surveyed included primary-care doctors and psychiatrists.” 

On the other hand, the patients generally expect that the prescribed drugs will be safe. They want to administer evidence based approved medicines. Some of them have even started expressing that these evidences must also be disclosed to them.

Hence, there seems to exist a clear conflict of interest in this matter between the patients, drug manufacturers and perhaps the doctors, as well.

Conclusion:

The magnitude of general off-label use of drugs is reportedly increasing and is likely to increase further, exposing patients to increased risks of ADEs.  Although the business consequences of getting engaged in this unwanted process indiscriminately could at times be quite adverse, in the balance of probability between slim chances of getting caught, and expected creamy return, many pharma players continue to feel that this risk is worth taking.

Therefore, the moot question that needs a pragmatic answer is, for patients’ safety, when the global and local pharma majors talk about prescriptions of only impeccable evidence based medicine, do they walk the talk?

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.

 

Should India allow use of Compulsory License as a common tool to improve access to medicines?

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Compulsory License (CL) is generally considered a very important provision in the Patent Act of a country to protect public health interest not only by the governments, but also by a large number of experts across the globe and the intelligentsia within the civil society.

The key objectives:

The key objectives of the CL provisions in the statute are to:

  • Rectify any type of market failure
  • Discourage abuse of a patent in any form by the patent holder

WHO hails CL provisions:

‘The World Health Organization (WHO)’ says that ‘the provision for Compulsory Licenses (CL) is a critical element in a health-sensitive patent law’. It emphasized that CL constitutes an effective mechanism to:

-     Promote competition

-     Increase affordability of drugs, while ensuring that the patent owner obtains compensation

for the use of the invention

-     Lack or insufficiency of working of patent

-     Remedy of anti-competitive practices

-     National emergency

-     Government use for non-commercial purpose

-     Other public interest grounds

WHO also recommends the use of CL for any “abuse of patent rights”. This is primarily to ensure that drug prices remain consistent with local purchasing power.

Even ‘UNAIDS’ have recommended the use of CL, as provided under the TRIPS Agreement, where countries have the right to issue such licenses.

Views of R&D based pharma companies:

It is well known that the provisions for the grant of CL other than national emergencies have been generally opposed by the research-based pharmaceutical industry on the grounds that they discourage investments on R&D.

Despite such opposition, most developed countries have CL provisions in their law, which the respective governments can use to promote competition and access to medicines.

Provisions for CL in TRIPS Agreement:

While TRIPS agreement does not limit the grounds or reasons for granting CL, countries can only use those grounds which are allowed by their own national legislation. The development of appropriate national legislation is therefore crucial.

TRIPs further states that the conditions under which a compulsory license is granted should be regulated in accordance with the TRIPs Agreement (Article 31), under a number of conditions aimed at protecting the legitimate interests of the right holder.

Examples of CL provisions in some important countries:

China: Quite close on the heel of grant of Compulsory License (CL) to Bayer AG’s expensive Kidney and Liver cancer drug Sorafenib Tosylate to the domestic Indian manufacturer Natco by the Indian Patent Office, as provided in the Indian Patent Law, China amended its own Patent Law allowing Chinese pharmaceutical manufacturers to make cheaper generic equivalent of patented medicines in the country not only during ‘state emergencies’, but also in ‘unusual circumstances’ or ‘in the interests of the public’.

U.S: Patent law does not provide for CL, which is allowed under the antitrust law. US has been granting CL to remedy anti-competitive practices and for governmental use, including national security.

Canada:  The country introduced CL for drugs, way back in 1923. Canada has granted number of CLs and a robust generic pharmaceutical industry exists in that country.

France: French law authorizes CL when medicines are “only available to the public in insufficient quantity or quality or at abnormally high prices”.

Israel: In Israel a CL can be granted, “if it is necessary to assure the public of a reasonable quantity of a product capable of being used as a medicament, to manufacture a medicament or a patented process for manufacturing a medicament.”

Brazil:  The country will grant CL in cases of “national emergency or public interest, declared by the Federal Executive Authorities. A temporary nonexclusive compulsory license can be granted if necessary. Brazil defines Public Health interest to include “public health protection, satisfying nutritional requirements, protection of the environment and other areas of fundamental importance to the technological or social and economic development of the country.”

Very few CLs granted between 1995-2012:

Despite having the provisions for the grant of CL in many countries, not many CLs have been granted across the world from 1995 to date. The details are as follows:

Country Medicine CL granted in
Israel Hepatitis B Vaccine October 1995
Italy Imipenem (antibiotic) June 2005
Italy Sumatripan Succinate (migraine) February 2006
Canada Oseltamivir (influenza) July 2006
Brazil Efavirenz (HIV/AIDS) May 2007
Thailand Erlotinib, Docetaxel (cancer) January 2008
India Sorafenib Tosylate (cancer) March 2012

Source: DNA, March 9, 2012

India joins the league in 2012:

Indian Patent Office granted a Compulsory License (CL) for Sorafenib Tosylate (Nexavar of Bayer Corporation) to Hyderabad based Natco Pharma Limited under the provisions of Section 84 of the Indian Patents Act. Nexavar is used for treatment for liver and kidney cancer.

The Compulsory License, first of its kind granted in India, enables Natco to sell the drug at a price not exceeding Rs. 8880 (US$ 178 approx.) for a pack of 120 tablets (one month’s therapy) against Rs. 284,428 (US$ 5,690 approx.) being the cost of Nexavar sold by Bayer before the CL was granted to Natco. The license is valid till the expiry of the patent on 2021.

The order on CL also makes it obligatory for Natco to supply the drug free of cost to at least 600 needy and deserving patients per year.

The grant of CL generated adverse impact from many developed nations of the world, as was expected by many.

However, welcoming the order Natco reportedly commented, “This opens up a new avenue of availability of life savings drugs at an affordable price to the suffering masses in India.”

Does grant of CL for non-NLEM products make sense in India?

Currently all government healthcare initiatives in India are focused on ‘The National List of Essential Medicines 2011 (NLEM 2011)’, be it drug price control, free distribution of medicines to all through government hospitals/health centers or even much hyped, ‘Universal Health Coverage’ proposal.

In this situation, another school of thought says that by granting CL to Natco for Sorafenib Tosylate (Nexavar of Bayer), which does not fall under NLEM 2011, hasn’t India diluted its focus on essential drugs? More so, when NLEM 2011 features quite a good number of anti-cancer drugs, as well.

The other side of the argument: Is CL a viable solution to improve access in the developing nations?

International Policy Network (IPN) in an article titled, “Compulsory licensing no solution to health problems in poor countries – say experts from India, Argentina, Canada and South Africa” stated that patents and other forms of Intellectual Property (IP) are an essential component in economic development of any emerging economy, which needs to be well protected by the governments.

The article further opines that any form of interference with IP by the grant of CL or even price controls will undermine investments and cause more harm than good. The paper, therefore, calls for stronger protection of IP across the world.

Yet another paper  titled, “The WTO Decision on Compulsory Licensing – Does it enable import of medicines for developing countries with grave public health problems”, states that flexibility of innovator companies to adjust prices according to purchasing power of the people of different countries is constrained by the following two reasons:

  • A genuine risk that medicines sold at lower prices in the developing countries will be re-exported to high income markets.
  • Many high income developed countries also regulate the prices of medicines at the national level. There is a high risk that these countries will use prices in the developing markets as external reference pricing.

Thus, the author argues, in both the above situations, patented medicine prices will be undermined in the most important markets, making it difficult for the research-based companies to use prices only of high income countries to fund R&D costs for the discovery of new medicines.

Fostering innovation in India:

The healthcare industry in general and the pharmaceutical sector in particular have been experiencing a plethora of innovations across the world, not only to cure and effectively manage ailments to improve the quality of life, but also to help increasing overall disease-free life expectancy of the population with various types of treatment and disease management options.

Innovation being one of the key growth drivers for the knowledge economy, the creation of an innovation friendly ecosystem in India calls for a radical change in our mind-set.

From process innovation to product innovation, from replicating molecules to creating new molecules- a robust ecosystem for innovation is the wheel of progress of any nation, and India is no exception. It is encouraging to hear that the Government of India is working towards this direction in a more elaborate manner its 12th 5 year plan.

However, the question that is being raised now: will frequent grant of CL vitiate the attempt of the government to create an innovative culture within the pharmaceutical industry in India. 

CL will not arrest increasing ‘OoP’ for healthcare in India:

While India is making reasonable strides in its economic growth, the country is increasingly facing constraints in proving healthcare benefits to a vast majority of its population with ballooning ‘Out of Pocket (OoP)’ expenditure of around 78 per cent of its population.

This is mainly because of the following reasons:

  1. Absence of ‘Universal Health Coverage’
  2. Lack of proper healthcare financing and insurance system for all strata of society
  3. Difficulty in managing the cost of healthcare even when the country is providing generic drugs for a sizable part of the world market

One finds some good initiatives though, for population Below the Poverty Line (BPL) and hears about the success of ‘Rashtriya Swasthya Bima Yojna (RSBY)’ and other health insurance schemes through micro health insurance units, especially in rural areas. It has been reported that currently around 40 such schemes are active in the country.

As the disease pattern is undergoing a shift from acute to chronic non-infectious diseases, OOP on healthcare will increase further.

Currently health insurance schemes only cover expenses towards hospitalization. Ideally, medical insurance schemes in India should also cover domiciliary or in-patient treatment costs and perhaps loss of income too, along with hospitalization costs, if India wants to bring down the OoP for its population or at least till such time the ambitious ‘Universal Health Coverage’ project gets translated into reality.

Greater focus of the Government in these areas, many believe, will help increasing access to essential medicines very significantly in India, rather than frequently granting CL, as is being envisaged by many, especially for drugs, which are outside NLEM 2011.

Access to patented medicines unlikely to be addressed effectively despite frequent grant of CL: 

As we know, access to healthcare comprises not just medicines but more importantly healthcare infrastructure like, doctors, paramedics, diagnostics, healthcare centers and hospitals . In India the demand for these services has outstripped supply. There is a huge short fall in ‘Healthcare Manpower’ of the country as demonstrated in the following table:

Target

Actual

Shortfall %
Doctors

1,09,484

26,329

76
Specialists

58,352

6,935

88
Nurses

1,38,623

65,344

53
Radiographers

14,588

2,221

85
Lab Technicians

80,308

16,208

80

Source: Rural Health Statistics 2011 in 12th Plan draft chapter

Thus, there is an urgent need to have a holistic approach with the ‘Universal Healthcare’ in developing adequate healthcare infrastructure, efficient delivery system for medical supplies and creation of a talent pool of healthcare professionals and paramedics, to ensure access to healthcare for all the citizens of the country.

Without all these how will the diseases be diagnosed and the patients be treated for ailments, frequent grant of  CL not withstanding? 

Conclusion:

Be that as it may, the prices of medicines in general and the patented drugs in particular will continue to remain highly sensitive in most parts of the world, if not all, which some astute Global CEOs of the pharmaceutical majors have already contemplated.

One of these Global CEOs very aptly commented, “Pharmaceutical industry, too, on its part, needs to metamorphose to strike a balance in delivering affordable and innovative medicines. It is unacceptable to hear of the US$1billion cost to develop a drug, which includes the cost of failure. We need to fail less often and succeed more often.”

He reiterated, “Pharma companies need to understand that just because you have a patent, people don’t suddenly have money in their pockets, or can afford American prices.”

In the same context another Global CEO said, “Our strategy is really to have affordable medicines because in emerging markets you do not have government reimbursement. So you have to have medicines that people can afford to pay for.…I do not want us to be a colonial company with a colonial approach where we say we decide on the strategy and pricing. If you have to compete locally then the pricing strategy cannot be decided in Paris but will have to be in the marketplace. People here will decide on the pricing strategy and we have to develop a range of products for it.”

Keeping all these developments in view, as I said before, the contentious issue of the price of medicines cannot just be wished away across the world, which is perhaps more relevant now than ever before.

This is irrespective of the fact whether the country provides likes of ‘Universal Health Coverage’ or is driven by OoP expenditure by the majority of its population. Gone are those days, as articulated by the above Global CEOs, when a single global price for a product will be acceptable by all the nations across the world. India seems to be moving to this direction cautiously but steadily. 

It appears, responsible pricing and effective working of patents are the only answers to respond to the CL issue in India.

Thus, I reckon, it does make sense for India to have the relevant provisions of CL in its Patent Act, not just to rectify any type of market failure, but also to discourage any possible abuse of a patent in any form by the patent holder in the country, as mentioned above.

However, it is also important for India to examine the potential negative impact of CL to foster innovation in the country and the global ramification of the same, including attraction of more ‘Foreign Direct Investments (FDI)’, which has been universally proved to be so important for the economic progress of any country, like India and China.

That said, while none can deny that all citizens of India should have access to affordable life-saving essential medicines, it appears rather impractical to envisage that routine grant of CL by the Indian Patent Office, as enumerated above by Natco et al, will be able to resolve the critical issue of improving access to essential medicines on a longer term basis in India.The decision for grant of CL, I reckon, should be taken in India only after exhausting all other access improvement measures.

As enumerated above, the use of CL as a common tool to improve access to medicines could prove to be counterproductive in the long run for India.

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.

Limiting FDI in Pharma is a protectionist cry: Does not benefit the common man.

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“Protectionism is harmful” very aptly commented by Mr. Pranab Mukherjee, the Finance Minister of India, just the other day. This was in context of “recent US moves to hike visa fees and clamp down on outsourcing”.
While almost at the same time, both Indian and the foreign media reports indicate that being concerned by the recent acquisitions of the home grown relatively large pharmaceutical and biotech companies, the Department of Pharmaceuticals (DoP) and the Department of Industrial Policy and promotion (DIPP) of the Government of India are mulling a proposal to do away with the current practice of allowing 100% Foreign Direct Investments (FDI), as applicable to the pharmaceutical industry in India.

Even the Health Minister of India has been expressing this concern since ‘Abbott – Piramal deal’ was inked last year. He expressed the same apprehension, as he read out from his written speech, in an industry function in Mumbai held on January 7, 2011.

Thus the moot question is, will limiting FDI in pharmaceuticals be not considered by the world as a protective measure, just as ‘hiking visa fees and clamping down outsourcing’ from India by other countries?
Is it a mere speculation?
I would reckon so, as at this stage India cannot afford to take any retrograde anti-reformist measure in its endeavor to further accelerate the economic progress of the nation. The Finance Minister of India has also expressed so publicly, in the same context, quite recently.
Still the speculation is quite rife that a new cap of 49% FDI for pharmaceuticals would be able to keep the multinational companies (MNCs) away from having controlling stakes in the Indian companies, which will not jeopardize access to quality medicines at an affordable price to a vast majority of the population.
The key apprehensions:
The Department of Industrial Policy and Promotion (DIPP) of the Ministry of Commerce and Industries in its ‘Discussion Paper’ dated August 24, 2010, which was primarily on Compulsory Licensing (CL), also expressed some of the following key apprehensions towards foreign acquisitions of the Indian pharmaceutical companies by the MNCs:
1. Such takeovers could lead to an ‘oligopolistic market’ where a few companies will decide the prices of essential medicines, adversely impacting the ‘Public Health Interest (PHI)’.
2. If large Indian companies having the wherewithal to replicate any patented molecule are taken over by the MNCs, the ‘oligopolistic’ situation thus created and being strengthened by the exclusivity of products through product patent rights, will severely limit the power of the government to face the challenge of PHI by granting CLs.
3. In such a situation MNCs could well decide to sell only the high priced patented and branded generic drugs rather than the cheaper essential drugs, pushing up the drug prices and causing inconvenience to patients.
Addressing the key apprehensions:
Let me now try to address these apprehensions impartially and with as much data as possible.
1. Can Indian Pharmaceutical Market (IPM) be ever oligopolistic? Dictionary defines ‘Oligopolistic market’ as ‘a market condition in which sellers are so few that the actions of any one of them will materially affect price and have a measurable impact on competitors’.
IPM has over 23,000 players and around 60,000 brands (source: IMS 2010). Even after, all the recent acquisition, the top ranked pharmaceutical company of India – Abbott, enjoys a market share of just 6.1% (source: AIOCD/AWACS , November 2010). Even the Top 10 groups of companies (each belonging to the same promoter group though different and not the individual companies) contribute just around 40% of the IPM.
Thus, IPM is highly fragmented. No company or group of companies enjoys any clear market domination. In a scenario like this, the apprehension of an ‘oligopolistic market’ being created through acquisitions by the MNCs is indeed unfounded.
2. The idea of creating a legal barrier in terms of limiting the FDIs to prevent the domestic pharma players from selling their respective companies at a price, which they would consider lucrative, just from the CL point of you, as mentioned in the ‘discussion paper’ of DIPP, sounds bizarre.
3. The market competition is also extremely fierce in India with each branded generic/generic drug (constituting over 99% of the IPM) having not less than 50 to 60 competitors within the same chemical compound. Moreover, 100% of the IPM is price regulated by the government, 20% under cost based price control and the balance 80% is under stringent price monitoring mechanism. In an environment like this, the very thought of any threat to ‘public health interest’ due irresponsible pricing, may be taken as an insult to the government’s own price regulators, who have contributed in making the medicine prices in India cheapest in the world, cheaper than even our next door neighbors like, Bangladesh, Pakistan and Sri Lanka.
Hard facts tell us a different story:
The apprehension that acquisition of Indian drug companies by MNCs will hurt the consumer interest is not based on hard facts. MNCs constitute 19% of the total share of the Indian pharmaceutical market in value terms. Of the 455 companies listed in IMS ORG, 38 are foreign owned (only 8.4%). The fragmented nature of the industry ensures high level of competition that has led to the lowest prices of essential medicines in India.

Ranbaxy was the first major Indian drug company to be acquired by the Japanese MNC Daiichi Sankyo in June 2008. Two years later, the prices of medicines of Ranbaxy have remained stable, some in fact even declined. As per IMS MAT June data, prices of Ranbaxy products grew only by 0.6% in 2009 and actually fell by 1% in 2010.
Access to world class science and technology:
Even the acquisition of Shantha Biotechnique by Sanofi-aventis has enabled the domestic bio-tech company to get world class R&D support and international exposure in partnership with the one of the world’s largest vaccines development company – Sanofi-Pasteur. It is worth noting that none of the prices of locally produced vaccines by Shantha Biotechnique has gone up after this acquisition.
Data also shows that the number of products under price control is now much higher for MNCs in general than the domestic drug companies.
Other positive fall outs of acquisitions/collaborations:
All these acquisitions were absolutely voluntary in every way and brought in for the country large amount of foreign investments as can be seen in the Piramal Healthcare buyout amounting to US $3.72 billion and earlier the Ranbaxy buyout of US $4.2 billion. Such acquisitions also help in shifting investment and R&D focus of the MNCs into India, which offers good science and technology base with a significant cost arbitrage.
Conclusion:
In my opinion, through partnering with MNCs, local drug companies have begun to gain access to international expertise, resources and good manufacturing practices. A number of local companies have already entered into alliances with MNCs to leverage these opportunities.
Thus limiting FDI in the pharmaceutical industry at this stage, when the government in fact is debating to open up the retail and the insurance sectors to foreign investments will indeed be a retrograde step for the country.

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.

85% of the patented new drugs have therapeutic equivalents…they do not increase the cost of treatment for the common man: Points…Counterpoints

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Affordability of patented drugs has become a major controversial and at the same time a very sensitive issue in the healthcare space of India, just as in many other parts of the world. The government, the NGOs and other stakeholders, on the one hand, seem to be quite concerned about it. Innovator companies, on the other hand, also have quite robust arguments in their favor.

Meanwhile, the daily newspaper ‘DNA’ published a report on June 15, 2010 with a headline, “NPPA may cap cancer drug prices via Para 10’.

Let us now try to go through the points and counterpoints of this raging debate.

The basic reasons of concern:

The key points for this concern, I reckon, is based on the following two beliefs:

1. All our citizens should have access to all new drugs
2. All these new drugs are essential to treat most of the related disease conditions

Points in favor of free pricing for patented new drugs:

- Price is a function of the value that a patented new drug will offer to the patients. The price of new drugs will, in addition, include components of the cost incurred by the innovators towards research and development, to offer these products to the patients. This is absolutely essential to ensure continuous investment towards R&D by the innovator companies to meet the unmet needs of the patients.

- It has been reported that currently only 2.3% of the Indian Pharmaceutical Market (IPM) will represent drugs, which have no therapeutic equivalent. This means over 97% of the IPM constitutes of medicines, which have one or more therapeutic equivalents.

- So far as the patented products are concerned, over 85% of all those will have therapeutic alternatives. Empirical evidence suggests that just around 15% of the patented molecules have significant therapeutic advantages over existing drugs and cannot be replaced.

- Beta-lactam, Cephalosporin and Quinolone group of antibiotics are still relevant today and will remain for many more years. So are the likes of Beta Blockers, Calcium antagonists, Ace inhibitors, Proton Pump inhibitors and Statins.

- Therefore, all patients with any common disease profile will have adequate and a good number of cheaper treatment options with the generic drugs. As all new drugs are not essential to treat all related disease conditions, generic and patented medicines should co-exist to cater to the healthcare needs of patients of all income groups. Those who can afford to pay extra for the incremental value of such patented drugs should also have an option.

The Counter points:

- The opponents of the above argument raise the counter question, “if 85% of the patented drugs will have appropriate therapeutic equivalents, why then the pharmaceutical companies spend such a huge amount of money and other resources towards R&D to invent molecules, which do not add significant and substantial value to the existing ones to treat patients? Rationalization of such avoidable R&D expenditures will help reducing the price of even path-breaking patented molecules for the treatment of many disease conditions of the ailing patients”

- In this context ‘Australian Prescriber (2004; 27:136-7)’ commented:

“The patent system, which assumes that investment in the development of new drugs, is so important that the principles of the free market should be abrogated to reward pharmaceutical companies with a legally enforced period of protection from competition”.

- NGOs with a differing view point ask, “Many patented products are still not available in India, does the medical profession in the country find themselves seriously handicapped for not having access to these drugs?’

- This group puts forth the counter argument, “patent protection is based on the fundamental belief that for continuing investment to invent newer drugs, innovations must be adequately rewarded through appropriate protection of the patents. Thus patent protection should only be given to those innovations for which no therapeutic equivalents are available.”

Conclusion:

A die-hard protagonist for fostering innovation commented, though the exclusivity for a patented drug given to an innovator would last for 20 years, the real commercial benefits will be available for just around 10 years, that too after spending a fortune towards R&D. Whereas, post patent expiry, the commercial benefits to the generic manufacturers (virtually spending nothing towards R&D) for the same molecule will last in perpetuity…for the patients’ sake!

By Tapan 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.

Are common patients in India just as the pawns of the game of chess or the victims of circumstances or both, in the socio-economic milieu of the country?

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“Public healthcare in India has the power to deliver improved health outcomes, as demonstrated by a growing number of national and international examples. However, supportive policies need to be put in place in order to change traditional determinants of health,”said Professor Sir Andrew Haines, Director, London School of Hygiene and Tropical Medicine at the third foundation day function of the Public Health Foundation of India (PHFI), not so long ago.The healthcare industry of India has indeed this power, which can catapult the industry to a growth orbit to generate an impressive revenue of around US$.150 billion by 2017 as estimated by India Brand Equity Foundation (IBEF) in November 2009. This growth will be driven primarily by the private investments in country.Be that as it may, the current healthcare standard and infrastructure in India, as we all know, is far from satisfactory. Though we have some healthcare centers of excellence spread sporadically across various cities and towns of India, public healthcare facilities are grossly inadequate to satisfy the current healthcare demand of the common man of India.

Healthcare spends in India:

Although total health spending of the nation is around 6 percent of its GDP being one of the highest within the developing countries of the world, public expenditure towards healthcare is mere 0.9 percent of the GDP and constitutes just a quarter of the total healthcare cost of the nation. According to a World Bank study, around 75 percent of the per capita spending are out of pocket expenditure of individual households, state and the union governments contribute around 15.2 percent and 5.2 percent respectively, health insurance and employers contribute just 3.3 percent and foreign donors and state municipalities contributing the balance of 1.3 percent.

Out of this meager allocated expenditure only 58.7% goes for the primary care.

Four essentials in Primary Healthcare:

When it comes to Primary Healthcare, following are the well accepted essentials that the government should effectively address:

1. Healthcare coverage to all, through adequate supply of affordable medicines and medical services

2. Patient centric primary healthcare infrastructure and networks

3. Participative management of healthcare delivery models including all stakeholders with a change from ‘supply driven’ to ‘demand driven’ healthcare program and policies

4. Health of the citizens should come in the forefront while formulating all policies for all sectors including industry, environment, education, deployment of labor, just to cite a few examples.

It is unfortunate that most of these essentials have not seen the light of the day, as yet.

The key reason for failure:

Inability on the part of the central government to effectively integrate healthcare with socio-economic, social hygiene, education, nutrition and sanitation related issues is one of the key factors for failure in this critical area.

Moreover in the healthcare planning process, health being a state subject, not much of coordinated planning has so far taken place between the central and the state governments to address the pressing healthcare related issues.

In addition, budgetary allocation and other fiscal measures, as stated earlier, towards healthcare both by the central and the state governments are grossly in adequate.

National Rural Health Mission (NRHM) – a good beginning:

To address this critical issue, the National Rural Health Mission (NRHM) was conceived and announced by the government of India. NRHM aims at providing valuable healthcare services to rural households of the 18 States of the country namely, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Himachal Pradesh, Jharkhand, Jammu and Kashmir, Manipur, Mizoram, Meghalaya, Madhya Pradesh, Nagaland, Orissa, Rajasthan, Sikkim, Tripura, Uttarkhand and Uttar Pradesh, to start with.

The key objectives of this novel scheme are as follows:

• Decrease the infant and maternal mortality rate
• Provide access to public health services for every citizen
• Prevent and control communicable and non-communicable diseases
• Control population as well as ensure gender and demographic balance
• Encourage a healthy lifestyle and alternative systems of medicine through AYUSH

As announced by the government NRHM envisages achieving its objective by strengthening “Panchayati Raj Institutions” and promoting access to improved healthcare through the “Accredited Female Health Activist” (ASHA). It also plans on strengthening existing Primary Health Centers, Community Health Centers and District Health Missions, in addition to making maximum use of Non-Governmental Organizations.

NRHM is expected to improve access to healthcare by 20 to 25 percent in the next three years:

To many the National Rural Health Mission (NRHM) has made a significant difference to the rural health care system in India. It now appears that many more state governments are envisaging to come out with innovative ideas to attract and retain public healthcare professionals in rural areas.

On January 11, 2010, the Health Minister of India Mr. Ghulam Nabi Azad, while inaugurating the FDA headquarters of the Western Zone located in Mumbai, clearly articulated that the NRHM initiative will help improving access to affordable healthcare and modern medicines by around 20 to 25 percent during the next three years. This means that during this period access to modern medicines will increase from the current 35 percent to 60 percent of the population.

If this good intention of the minister gets translated into reality, India will make tremendous progress in the space of healthcare, confirming the remarks made by Professor Sir Andrew Haines, Director, London School of Hygiene and Tropical Medicine, as quoted above.

Is NRHM scheme good enough to address all the healthcare needs of the country?

NRHM is indeed a very good and noble initiative taken by the government to address the basic healthcare needs of the rural population, especially the marginalized section of the society. However, this is obviously not expected to work as a magic wand to resolve all the healthcare related issues of the country.

Are patients the pawns of the game of chess or the victims of circumstances or both of the socio-economic systems?

Currently, some important stakeholders of the healthcare industry seem to be using the patients or taking their names, mainly for petty commercials gains or strategic commercial advantages. They could be doctors, hospitals, diagnostic centers, pharmaceutical industry, activists, politicians or any other stakeholders. It is unfortunate that they all, sometime or the other, want to use the patients to achieve their respective commercial or political goals or to achieve competitive gains of various types or just for vested interests..

‘The Patient centric approach’ has now become the buzz word for all – do we ‘walk the talk’?

There does not seem to be much inclusiveness in the entire scheme of things in the private healthcare system, excepting some odd but fascinating examples like Dr. Devi Shetty, Sankara Nethralaya etc. As a result, excepting the creamy layers, patients from all other strata of society are finding it difficult to bear the treatment cost of expensive private healthcare facilities.

I personally know a working lady with a name Kajol (name changed) whose husband is suffering from blood cancer. One will feel very sad to watch how is she fast losing all her life’s savings for the treatment of her husband, pushing herself, having no alternative means, towards an extremely difficult situation day by day. There are millions of such Kajols in our society, who are denied of effective public healthcare alternatives to save lives of their loved ones.

If all stakeholders are so “patient centric” in attaining their respective objectives, why will over 650 million people of India not have access to modern medicines, even today? Is it ALL for poor healthcare infrastructure and healthcare delivery system in the country? If so, why do we have millions of Kajol’s in our country?

Consumer awareness and pressure on healthcare services and medicines in India will increase – a change for the better:

With the winds of economic change, rising general income levels especially of the middle income population, faster awareness and penetration of health insurance among the common citizens, over a period of time Indian consumers in general and the patients, in particular, like in the developed countries of the world, will start taking more and more informed decisions by themselves about their healthcare needs and related expenditure through their healthcare providers.

As the private healthcare providers will emerge in India, much more in number, like the developed world, they will concentrate not only on their financial and operational efficiencies exerting immense pressure on other stakeholders to squeeze out the best deal at the minimal cost, but also to remain competitive will start charting many uncharted frontiers and explore ways of enhancing the ‘feel good factors’ of the patients through various innovative ways… God willing.

Conclusion:

All stakeholders of the healthcare industry need to think of inclusive growth, not just the commercial growth, which could further widen the socio-economic divide in the country, creating numbers of serious social issues. As we know, this divide has already started widening at a brisk pace, especially in the healthcare sector of the country

It is hightime for the civil society, as well, to ponder and actively participate to make sure that the inclusive growth of the healthcare sector in India takes place, where like primary education, primary healthcare should be the ‘fundamental right’ for ALL citizens of the country.

By Tapan 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.

‘Jan Aushadhi’ – ‘Medicines for the common man’ project of DoP is a great idea – is it on course?

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In mid 2008 The Government of India created a new department, ‘The Department of Pharmaceuticals’ (DoP), under the Ministry of Chemicals and Fertilisers. The new department came out with its following vision statement:“To enable Indian pharmaceuticals industry to play a leading role in the global market and to ensure abundant availability, at reasonable prices within the country, of good quality pharmaceuticals of mass consumption.”‘Jan Aushadhi’ – ‘Medicines for the common man’:

In this article, I shall submit my point of view on the second part of the above vision statement, which articulated the responsibility of the department to ensure availability of affordable modern medicine for ‘mass consumption’.

When over 70% of Indian population lives in rural areas, one can quite easily assume that such medicines will be available adequately in rural areas of the country, as well. Obviously the question that follows this admirable vision statement is how?

To respond to this question one will try to address the following two basic strategic issues:

1. Create a workable and viable business model, which can be gradually developed over a period
of time to deliver the promise

2. Create a robust supply chain network to ensure easy access of these medicines to the common
man, located even in remote rural areas.

The first part of the strategic issue has been well addressed by the DoP, within a very short period, by creating ‘Jan Aushadhi’, the medicines for the masses. Importantly, the second point, which will determine the success of the project, has not been clearly articulated.

The objectives of the ‘Jan Aushadhi’ were stated as follows:

1. To promote awareness for cost effective quality generic medicines. (However, how exactly this will be done, is yet to be known.)

2. To make available unbranded affordable quality generic medicines through private public partnership (PPP). (I support this objective from procurement perspective. However, so far as the delivery of these medicines to the common man is concerned, I would argue below:why do we reinvent the wheel?)

3. To encourage doctors in the Government Hospitals to prescribe such cost effective quality
generic medicines. (This is again just a statement of intent without considering the critical issue of its implementation in the predominantly branded generic market, like India.)

4. To help patients save significantly towards medicine cost with ‘Jan Aushadhi’ outlets.

5. A national help line is believed to be able to increase awareness level of this initiative.

The statements of intent of the DoP also highlight that the State Governments, NGOs and Charitable bodies will be encouraged to set up such generic medicine shops. It also states that the existing outlets of the Government and NGOs may also be used for this cause.

This particular decision of DoP, as I stated before, appears to be an attempt to ‘re-invent the wheel’, as it were. I shall argue on this subject, very shortly.

An open ended launch plan with inadequate market penetration compared to set objectives:

DoP announced that this scheme will be launched gradually in all the districts of India in four phases. However, for some unknown reasons, besides phase one and two, the other two phases of the launch plan have been kept by the department, as open ended as it could be, despite the Government of India’s having all wherewithals to implement this scheme with a reasonable degree of preciseness.

The four phases were decided as follows:

1. Phase 1: Amritsar Civil Hospital in November 8, 2008

2. Phase 2: Few stores in Delhi, National Capital Region (NCR), district hospitals in Mohali,
Ludhiana, Bhatinda and Jalandhar by February 28, 2009

3. Phase 3: Other districts of Punjab and some other states to be covered during 2009 and
2010

4. Phase 4: Remaining districts of the country by 2010 and 2012

I am not surprised that with such vague launch plan and an open ended timeline, the Government seems to have faltered in Phase 2 itself, when it could not go beyond Amritsar and Shastri Bhavan, Delhi outlets, by February, 28, 2009.

Arguing for the need of a course correction:

Despite being a hardcore optimist, I now get a vague feeling that the ‘Jan Aushadhi’ scheme of the DoP may not ultimately be able to achieve its cherished goals and may remain just as another good intention of the Government of India, if a course correction is not made at this stage.

The key barrier to improve access to affordable quality generic medicine to the common man, in this particular case, is not conceptualization of a project. We all know that our Government is reasonably good at it, with a good number of brilliant minds working to give a shape to it. The main weakness to translate this laudable idea into reality, in my view, falls well within the general weakness of the Government in visualizing the key barriers to the project and at the same time missing out on some of the key drivers for the same.

In this case, there seems to be some flaw in the ‘ideation’ stage of the project, as well. This flaw lies with the plan of its delivery mechanism involving state government, NGOs and various other bodies.

If procurement of cost effective quality generic medicines is not an issue, then the DoP should carefully look within the Government system to ensure easy access of such medicines to the common man.

Two grossly underutilized Government controlled ‘mass delivery systems’:

The Government of India has two very unique product distribution and delivery systems within the country with deep penetration from metro cities to even far off rural areas. These two Government owned supply and delivery chains are as follows:

1. Public Distribution System (PDS) for food grains and other essential commodities (Ration shops).

2. Indian Post Offices

Like food grains, medicines are also essential items. Why then DoP not collaborate with PDS to ensure easy access of such medicines to the common man?

Similarly, when postal department are collaborating with various other agencies to sell and distribute many types of products in rural areas, why not DoP consider this alternative, as well?

In fact, I would strongly recommend usage of both PDS and Post Offices by the DoP for deeper penetration of such medicines especially for the benefit of those 650 million people of India who do not have any access to affordable modern medicines.

I am aware, the question of ‘in-efficiency’ of these systems may be raised by many in India. However, at the end of the day who is responsible to make these systems efficient? People responsible for managing a system or process are usually held accountable for its ‘efficiency’ or ‘inefficiency’.

We have many excellent minds in the DoP, I hope, they may wish to explore the possibility of effectively utilizing these two already available state controlled mass distribution systems to ensure success of the project “Jan Ausadhi” – “Medicines for the common man”.

It is worth noting that this project seems to have already started limping with its vague execution plan and a delivery system, the scaling up of which to ensure access to one billion population of our country could be a serious question mark.

By Tapan 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.