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Is Criticizing Pharma Now Just A Fad?

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Is criticizing pharma now just a fad of its stakeholders? Fathoming the right answer to this seemingly simple question may not be too easy, either, for some. The task could even be more onerous, especially when the global ‘researched based’ pharma and biotech companies, well chorused by their trade associations, are exerting serious efforts to garner the much required trust of all stakeholders on their ‘patient centric’ focus in the process of transacting business.

This often repeated pledge, as it were, on ‘patient centric’ approach is indeed praiseworthy. There’s no two opinions about it, either. The new found interest of several ‘research-based’ pharma and biologic players to develop less expensive biosimilar drugs, to possibly improve patient access to otherwise expensive biologic medicines, post patent expiry, could well be a reiteration of the same and well publicized vow, of course if not proven otherwise.

A recent example:

In the context of ‘patient-centric’ approach with biosimilar product development by the world’s largest innovative biologic drug makers, let me quote the following recent example.

On September 23, 2016, by a Press Release, the Food and Drug Administration of the United States (US-FDA) announced regulatory approval of Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. This is the fourth FDA-approved biosimilar, after the new biosimilar pathway became effective in the US. Amjevita has been developed by Amgen Inc. – one of the global pioneers in the development of innovative biologic drugs.

According to US-FDA, a biosimilar is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

Although, Amjevita is biosimilar to Humira,  it has not been approved as an interchangeable product with Humira. This issue is considered as a major regulatory roadblock in the US for substitution of original biologic brands with their biosimilar equivalents, which can, therefore, be prescribed mostly to the new patients. It’s worth noting here that Humira – the blockbuster arthritis drug of AbbVie Inc. clocked a sale of US$ 14 billion in 2015, and probably will continue to do so in the foreseeable future, even long after patent expiry. I shall touch upon that point below, briefly.

It is estimated that the savings of putting just new patients on much less expensive biosimilar drugs, sans substitution of the expensive original brand, will be billions of dollars. Nonetheless, this will help reduce the cost of treatment with biologic medications, improving their access to many others.

A key barrier:

Interestingly, the barriers to following the biosimilar path are being mostly created none other than the innovative drug companies themselves, even post patent expiry, presumably to extend market exclusivity and monopoly pricing.

Arising out of one such key barrier, in the form of patent litigation, Amgen’s Amjevita, in all probability, may not be available to deserving patients for years. This could involve a protracted process of skillfully navigating through the labyrinth of legalities.

On August 05, 2016, The Wall Street Journal (WSJ) reported that AbbVie Inc. has filed a patent-infringement lawsuit against rival Amgen Inc., seeking to block sales of a lower-priced biosimilar of AbbVie’s top-selling, now generally considered as an off-patent drug – Humira.

When the narrative gets paradoxical:

While all the ‘research-based’ drug companies claim to be ‘patient-centric’ in their business approaches, be it with the development of biosimilars or in other areas, somewhere this narrative gets paradoxical.

On September 02, 2016, Reuters reported that global ‘research-based’ companies are now ‘waging courtroom patent battles against each other over biosimilars, as the line blurs between companies known for their innovative medicines, and those that produce cheaper biotech knockoffs.’

Some of the recent high-profile examples were reported as follows:

  • Sanofi sued Merck in the US federal court over its biosimilar version of Lantus insulin with around US$7 billion in annual sales.
  • Eli Lilly reached a royalties deal with Sanofi to end a similar Lantus-related lawsuit, but their pact means the biosimilar launch was likely delayed.
  • Pfizer and Korea’s Celltrion in August beat back a court challenge from Johnson & Johnson over US$10 billion autoimmune drug Remicade, though J&J’s Janssen unit promised to appeal.
  • In a closely watched case, Novartis wants the US Supreme Court to dump a six-month marketing delay for biosimilars, in what would be the first time the high court took up a biosimilar case.
  • Samsung Bioepis, along with partner and minority shareholder Biogen Inc, filed a lawsuit against AbbVie in Britain in March to stop the US company from blocking the launch of yet another Humira biosimilar.

It is equally noteworthy, while Amgen is keen to launch its own biosimilars, the company’s aggressive legal strategy delayed Novartis’s efforts to introduce the first US biosimilar, Zarxio, before the copy of Amgen’s US $1 billion drug Neupogen finally went on sale last year.

Further, Amgen has also filed a legal suit against a biosimilar version of its Enbrel (etanercept) developed by Novartis (Sandoz), which has already received regulatory approval from the US-FDA on August 30, 2016 for multiple inflammatory diseases.

Taking these into consideration, isn’t, therefore, about time to ponder afresh, whether the innovative drug makers’ general mindset of maintaining drug exclusivity with a very high price, on techno-legal grounds, even after enjoying price monopoly over a long period of the specified time, be termed as ‘patient-centric’?

Indian scenario:

Indian players have already started developing biosimilar drugs in the country. This market offers a lucrative future opportunity considering that original biologic brands with a global turnover of around US$ 70 billion will expire by 2020.

The first biosimilar was approved and marketed in India for a hepatitis B vaccine in 2000 (GaBI Online). By now, around 30 such products have reportedly received the Drug Controller General of India (DCGI)’s approval for marketing in India. Even after the new biosimilar guidelines were framed and implemented locally, since 2012, there has not been any worthwhile legal suits filed by the global innovative biologic manufacturers, against the Indian companies or such products developed and approved in India, till 2014.

Since then, this scenario has changed with Roche suing Biocon and its partner Mylan on their biosimilar versions of Roche’s Herceptin (Trastuzumab) for breast cancer, and also making the DCGI a party to this suit. This litigation is broadly on the following grounds:

  • Non-adherence to the Indian biosimilar guidelines
  • Misrepresentation of drugs as biosimilar and passing off 

Be that as it may, its key impact is on affordable biosimilar drugs that can save more lives of breast cancer patients in India. If it is so, do such litigations demonstrate a patient-centric perspective for so important a drug, which is not even protected by a product patent in India, any longer?

Are biosimilars the only examples?

Lest I am not seen as highlighting only the instances of blocking market entry of biosimilar drugs, as sole examples of ‘patient-centric focus’, or lack of it, of many global innovative drug manufacturers, I would now expand it, just a bit. This is only to fathom the bottom-line – whether it is a ‘patients-centric’ focus, or solely a ‘profit-centric’ outlook.

‘Patients-centric’ or ‘Profit-centric’?

To get a sense on this vexing issue, it would be worthwhile for us to find out by ourselves the most appropriate reason behind each of the following. Of course it’s just an illustration. This reason could be either a ‘patient centric’ focus, or simply a ‘profit centric’ outlook. …And then let’s try to make out which way the overall balance tilts, on the ground:

  • Discovering new drugs, delivery systems, and finding new indications
  • Lack of transparency and widely reported bias towards mainly positive results in clinical trial data, both for publication and regulatory approval of various new drugs, and associated global furor.
  • Exorbitant high prices of many new patented medicines and some generic drugs too
  • Widely reported marketing/other malpractices, and associated fines paid by the respective players
  • Causing entry delay for cheaper small molecule generics and large molecule biosimilar drugs post patent expiry restricting gtreaterr patient access

What’s your relative score now?

Conclusion:

Let me sign off here by raising the following relevant questions in this area, for all of us to think and address, as we deem appropriate:

Is the narrative of ‘patient centric’ approach of the ‘research-based’ global drug companies’ now getting clearer with the widely reported credible examples, as above?

Is there still a paradox between their two different strategic business approaches – one entry into off-patent drug development, such as biosimilars, and the other in blocking or delaying entry of such drugs, whenever possible, even after enjoying a specified period of product pricing monopoly?

Does it then mean, what a large section of pharma industry constituents is now publicly demonstrating, at least in the above areas, more than negates their protracted sound bites on ‘patient centric’ focus?

Despite these facts, would pharma related criticism in this space be termed as just a fad of the stakeholders?

If not, what should be the way forward from here to ensure that remedial measures are taken in so important an area of ‘patient-centric’ outlook, soon enough?

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. 

Declining MR Access to Doctors Prompts Increased Digital Engagement

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The trigger point for a disruptive change in the pharma marketing playbook now seems to be not just on the horizon, but could soon move to a countdown stage, in India.

On Friday, September 16, 2016, at a seminar on the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) organized at Bengaluru, Sudhanshu Pant, Joint Secretary (Policy), Department of Pharmaceuticals (DoP), India, reportedly said that the mandatory UCPMP is now in its last leg of clearance with the Union Government, after incorporating the inputs received from the pharma industry and other stakeholders.

He clearly articulated in his address, once a level playing field is created with mandatory UCPMP, both the pharma industry and the medical professionals will be restricted to offer and receive freebies, respectively, which is the in-thing today to generate prescriptions from the doctors.

“Our intent is that the new code should be followed in letter and spirit. It is not a draconian law, but penalties are stringent. We are enforcing fines. The violation of this code could also lead to suspension of product marketing,” the joint secretary further clarified.

Signals a forthcoming change:

Effective implementation of the mandatory UCPMP across India, could catalyze significant changes in the allegedly dubious pharmaceutical marketing process in India, revolving round ‘give and take’ of enticing ‘freebies’ to the prescribers. According to several reports, some of these practices are followed in the guise of ‘brand-reminders’, and several others fall under ‘events associated with Continuing Medical Education (CME), mostly arranged in various exotic places around the world, with associated hospitalities and equivalents. Besides, there exists a host of different kinds of ‘carrots for prescriptions’ of numerous types, forms and costs, as highlighted frequently by the national and international media.

Nevertheless, it is widely believed by many that Medical Representatives (MR) in India are having virtually no access barrier to meet the doctors, as a large number of both the receivers and the givers of the freebies have allegedly financial interest ingrained on meeting each other.

This scenario, I reckon, will change in India with the strict enforcement of mandatory UCPMP by the Government, curbing any possible misadventure by any stakeholder in the space of ethical pharma marketing practices that would impact the health interest of patients, directly.

Drawing a similar example:

One relevant example for India could be drawn from what happened in the United States (US) in this area, relatively recently. To contain wide-spread unethical pharma marketing practices in the US, President Obama administration enacted the Physician Payment Sunshine Act, effective August 1, 2013. This new law, that requires detailed disclosures from both the physicians and the pharma players on giving and accepting the freebies, limited the financial interest of the prescribers to meet with the MRs several times in a year, for face to face product detailing. Consequently, MR access to prescribers for the same started becoming increasingly more challenging.

A number of studies indicate, a large number of doctors have now started considering the delivery of a frequent barrage sales message an avoidable noise, when alternative highly user-friendly platforms are available to keep them up-to-date on various brands.

In the same way, as the new mandatory UCPMP will come into effect in India, it is quite likely that pharma companies operating in the country would start facing similar challenges with MRs visits, especially, to the important busy doctors and for similar reasons.

Digital channels are gaining strength:

With MRs access to physicians gradually declining, many pharmaceutical companies are trying to make the best use of a gamut of customized, innovative marketing approaches pivoted on various digital platforms. These initiatives are primarily to supplement effective engagement with the doctors to generate increasing prescription demand, and in a more user-friendly manner.

The latest study on trend:

There are many studies in this area, but I shall quote the latest one. According to a 2016 study of the global sales and marketing firm ZS Associates: “The number of digital and non-personal contacts that the pharmaceutical industry now has with physicians exceeded its number of sales rep visits to doctor offices.”

Analyzing the data from 681,000 health care providers who actually engage with pharmaceutical and biotech manufacturers across promotional channels, and more than 40,000 pharmaceutical sales representatives (MRs), the study reported, among others, the following:

  • 44 percent of physicians are “accessible” (that is, they met with more than 70 percent of sales reps who try to meet with them). This is a decline from 46 percent in 2015 and nearly 80 percent in 2008.
  • 38 percent of physicians restricted access (that is, they met with 31 to 70 percent of reps who try to meet with them).
  • 18 percent of physicians “severely” restricted access (that is, they meet with 30 percent or fewer reps who try to meet with them).
  • More than half (53 percent) of marketing outreach to physicians now takes place through “non-personal” promotion, such as email and mobile alerts, as well as direct mail and speaker programs.
  • The remainder of marketing to physicians (47 percent) still takes place through in-person interactions with sales reps (MRs).
  • Today’s physician estimates that he or she already spends 84 hours per year – about two full work weeks – interacting with pharma companies via digital and other non-personal marketing channels.
  • Around 74 percent of the physicians use their smartphones for professional purposes.

Another interesting point also emerges from the report. Despite the fact that non-personal communications, including digital, comprise 53 percent of marketing outreach most drug companies still allocate around 88 percent of their total sales and marketing budget to the sales force.

Increasing ‘online professional networks’ for doctors:

Keeping pace with this change several online professional networks for doctors are coming up. One such example is Doctors.net.uk. This is claimed to be the largest and most active online professional network for all UK doctors. Each day over 50,000 doctors make use of Doctors.net.uk to network with colleagues and view information.

This particular online facility provides the doctors with a range of free secure services including an email service, clinical forums, accredited education and medical news, which help them to keep up to date, and to easily maintain their Continuing Professional Development (CPD).

Some digital initiatives of pharma companies:

Here, I would quote just a couple of interesting examples out of several others:

For continuous online engagement with doctors:

In January 2013, the top global pharma major Pfizer launched an online digital platform for the doctors named ‘Pfizerline’. It provides access to the latest information on Pfizer products ‘when, where and how’ the doctors want it. As claimed by the company, ‘Pfizerline’ is regularly updated and forms part of the company’s ongoing commitment to keep the doctors informed about their products and services.

Some say that with ‘Pfizerline’, ‘Pfizer has begun using digital drug representatives to market medicines, leaving the decision as to whether they want to see them in doctors’ hands.’

For new product launch:

According to the Press Release published by PMLive, the first in the pharmaceutical industry ‘digital marketing only’ campaign was launched by Abbott for its Low Dose HRT brand, in November 2013.

The campaign reportedly reached to 9,000 doctors, 45 percent of the NHS population of obstetricians and gynecologists, and nearly 23 percent of GPs who engaged with Abbott’s Low Dose HRT brand via professional network Doctors.net.uk.

According to Abbott, as quoted in this report, the digital campaign, which included interactive case studies, clinical paper summaries and an ask the expert section, helped increase the brand’s market share, with a continuous month-on-month growth in sales in 2013.

I am quoting these two examples, just to illustrate the point that serious experimentations with digital marketing for serious business initiatives, such as, doctor engagement and product launch, have already commenced.

Conclusion:

For better physician engagement, while preparing for a likely future scenario in India, any effective brand marketing strategy on digital platforms would call for in-depth understanding of the target audience preferences on the specific information needs and marketing channels. This customized approach needs to be harnessed to deliver the right message, to the right customer, through right platforms, and at a time of preferred by each prescriber.

The ball game of pharma marketing is gradually but surely changing. Clear signals are now coming from various Governments to the pharma companies to jettison the widely perceived unethical practices of alluring the drug prescribers with ‘freebies’ of different kinds and values, against patients’ health interest.

Unless various third parties come-up just to camouflage continuation of the same unethical marketing practices of many companies, at a cost, getting unfettered MR access to busy prescribers is likely to be increasingly more challenging. Otherwise, effective enforcement of mandatory UCPMP is likely to usher-in this change in India, sooner, just as what the ‘Physician Payment Sunshine Act’ did in the US. The countdown for the new paradigm in the country is expected to commence soon, as reportedly articulated by the Joint Secretary (Policy) of the Department of Pharmaceuticals, recently.

However, there are a couple of points to ponder. It is also widely believed, even today, and also in the US that, while various digital platforms offer never before opportunity to effectively engage with ‘difficult to meet’ prescribers, their use should be prudent and well thought of. Any mass-scale and imprudent general switch to digital communications, is unlikely to fetch the best outcome, to meet with this evolving challenge of change, at least, in the foreseeable future.

At the same time, if pharma companies continue increasing investment in less expensive digital communications sans diligent homework for scaling up, the prescribers may feel so overwhelmed that they will start ignoring them, just as what’s happening with frequent MRs’ visits. Hence, for sustainable business excellence while confronting with forthcoming disruptive changes, the notes of the pharma marketing playbook need to be recomposed, afresh.

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. 

What Happens To Pharma’s Incredible Ride On The ‘Gravy Train’?

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India continues to be one of the fastest growing pharmaceutical market of the world with its over 40 percent of the total pharmaceutical produce is exported around the world. Over half of the total exports constitute of formulations, and the balance comprises of bulk drugs. India has been consistently maintaining its supremacy in the formulation exports since my salad days.

According to Export Statistics (2014-15) published by the Pharmaceutical Export Promotion Council of India (Pharmexcil), United States (US) is the largest market for the India’s pharmaceutical exports with a share of 27 percent of the total, followed by the United Kingdom (UK), South Africa, Russia, Nigeria, Brazil and Germany.

A red flag raised: 

Up until recently, it has almost been like walking over a bed of roses in this front for Indian pharma exporters. However, it does not seem to be so now, and at least in the foreseeable future, for a number of reasons.

The Press Release of ‘CRISIL Research’ dated May 17, 2016 has also raised a red flag in this area. The report foresees growth in pharma formulations (in US dollar terms) declining sharply to 10-12 percent annually over the next 5 years, as compared with a growth of ~19% seen in the last decade.

This adverse impact will be felt mostly in the US – the largest export destination of India, followed by the UK.

I reckon, there are three basic reasons for this changing scenario, namely, pricing, quality and lesser number of branded small-molecule blockbuster drugs going off patent.

The ride on the ‘gravy train’:

Pharma companies across the world consider that doing business in the US market would provide them a lot of money without facing any head wind, fundamentally driven by the drug pricing freedom in the country, as compared to any other market of the world.

This unfettered freedom of charging a hefty price premium in the largest pharma market of the world, on an ongoing basis, has been a critical factor of attraction for many pharma players to do business in the US, coming from various corners of the globe, including India, just as honey attracts the bees, as it were.

Thus far, it has been an incredible ride on the ‘gravy train’, as it were, for most of them.

However, ongoing activities of a large number of drug companies, dominated by blatant self-serving interests, have now given rise to a strong general demand for the Government to initiate robust remedial measures, soon. The telltale signs of which indicate that this no holds barred pricing freedom may not be available to pharma, even in the US, any longer.

In this article, I shall focus mainly on this point, drawing both global and local examples, as this development has a strong potential to add more to the existing miseries of many Indian drug exporters, of course in tandem with many other large MNCs.

Some recent developments: 

The April 21, 2016 issue of ‘The Financial Times’ quoted Joe Jimenez, the Global Chief Executive (CEO) of Novartis, where he said that pharma companies can no longer count on the “hockey-stick” trajectories for new products in the US. This is primarily due to the aggressive control of the drug expenses by the insurers and other healthcare payers, besides lawmakers and the public at large, of this most lucrative pharma market of the world.

As Jimenez said in the report, yesterday’s business model that pharma companies have followed since long, has now changed, slowing the pace of growth of innovative patented products in the US.

This trend is now heading north, primarily driven by the consolidation among the US insurers and healthcare providers. Consequently, the payers are making effective use of their greater bargaining power over the drug companies, especially to avail new incentives for cost savings, as provided in President Barack Obama’s Affordable Care Act, the article highlights.

To give a feel of it, I am quoting the example of a Novartis drug from the same ‘Financial Times’ article. It states, “Entresto, a treatment for heart failure, launched last year on the back of stellar clinical trial results, has so far sold more quickly in Europe than the US, marking a reversal of usual patterns in the pharma industry.”

A key differentiator in global ranking:

In this emerging scenario, all global companies will be adversely impacted for increasing pricing pressure in the US market.

This factor remaining the same for all the pharma players in the world, one of the key differentiating factors that would now play even more important role, is the richness of the advanced stage R&D pipeline of each innovator company.

For example, according to ‘Evaluate Pharma World Preview 2016, Outlook to 2022’ report, the overall R&D pipeline value of Roche is US$ 43.2 billion, far ahead of the same of Novartis’ US$ 24.1 billion and AstraZeneca’s at US$ 23.2 billion, followed by Eli Lilly, AbbVie, Pfizer, Sanofi, Celgene, Biogen and J&J and in that order. As a result, Roche is expected to overtake Novartis and Pfizer in the ranking by 2022, just when the global pharma industry would possibly cross as US$ 1Trillion mark.

Currently Novartis, though quite a small player in the Indian Pharmaceutical Market (IPM) holding the rank of 23 (AIOCD Pharmasofttech AWACS retail audit report, MAT August 2016), is number three in the global ranking, just ahead of Roche.

Indian generic players to feel the heat:

According to the Reuters report of September 11, 2016, US Department of Justice has sent summons this month to the US arm of Sun Pharma – Taro Pharmaceutical Industries Inc. and its two senior executives seeking information on generic drug prices. In 2010, Sun Pharma acquired a controlling stake in Taro Pharmaceutical Industries.

On September 14, 2016, quoting a September 8, 2016 research done by the brokerage firm IIFL, ‘The Economic Times’ reported that some large Indian generic drug manufacturers, such as, Sun Pharma, Dr. Reddy’s, Lupin, Aurobindo and Glenmark have also hiked the prices of some of their drugs between 150 percent and 800 percent in the US. This invites even more apprehensions in the prevailing scenario.

As I wrote in this Blog on September 12, 2016, the subject of price increases even for generic drugs has also reverberated in the ongoing Presidential campaign in the US.

The Democratic Party’s presidential nominee – Hillary Clinton has already promised, if elected in November 2016, she would constitute an ‘Oversight Panel’ to protect the consumers of her country from hefty price increases for long-available life-saving drugs.

Import bans:

In the midst of all this, import bans of a large number of formulations and bulk drugs by the US-FDA from several manufacturing facilities of Indian drug manufacturers of various scales and sizes, have further compounded the future risk potential of Indian pharma business growth in the US.

As investors are raising concerns, the following comment of the Co-Chairman and Chief Executive of Dr. Reddy’s Laboratories, reported by ‘Financial Express’ on August 24, 2015, well captures the pharma business risks in this area:

“The U.S. market is so big that there is no equivalent alternative. We just have to get stronger in the U.S., resolve our issues, build a pipeline and be more innovative to drive growth.”

However, this still remains a good intent. It is worth noting, for most Indian pharma exporters, the US is the single largest export market, with a stake, as high as nearly half of most of these companies’ annual revenue, and probably much more in profit, both of which are now showing a declining trend.

Price control coming in the UK:

On September 15, 2016, the Department of Health of the United Kingdom (UK) reportedly introduced a new Bill in Parliament to use its statutory power to limit the price of generic medicines where competition in the market fails, and pharma companies charge the NHS unreasonably high prices.

The Bill would also allow the government to apply penalties for non-compliance and to recover any payments owed through the courts following a right of appeal to a tribunal. The penalties can be a single penalty not exceeding £100,000 or a daily penalty not exceeding £10,000.

UK drug regulatory authorities had also announced import bans of APIs and formulations from some manufacturing facilities of a couple of leading Indian drug manufacturers, but on a lesser scale as compared to the USFDA.

Action in EU:

As reported by Bloomberg on July 22, 2016, The European Medicines Agency (EMA) has called for a halt to sales of hundreds of medicines that were tested in India, after an inspection of a research site found “substitution and manipulation” of the study samples. The affected companies include both large Indian and multi-national players.

According to a PTI report of July 27, 2015, after this incident Pharmexcil estimated that exports worth US$ 1-1.2 billion are likely to be affected, if cancellation of 700 generic drugs by the EU stands.

Conclusion:

All these developments, particularly on pricing and mostly in the US, could have a retarding effect on the business growth trend of a large number of global and local pharma companies.

Focusing nearer home, the evolving scenario in the world’s top pharma market, viewed together with what’s happening in Europe, both on pricing and the data integrity fronts, send a strong cautionary signal to the Indian drug exporters, in general.

Inadequate remedial measures could unleash this pressure to reach a dangerous threshold, impacting sustainable performance of the concerned companies. On the other hand, adequate remedial action, both strategic and operational in nature, could lead to significant cost escalation, with no space available for its neutralization through price increases, gradually squeezing the margin.

As I see it, ease of doing pharma business in these top export markets will no longer be quite the same as in the past. Many believe, pharma industry has invited these measures sans perceptible self-control, over a long period of time.

Is it mostly a self-inflicted injury of the industry players? The drug companies, in general, don’t believe so. Will this change be irreversible?  Only the future could unravel this. However, regarding the possibility of future US Government legislation on drug pricing, it’s now a wait and watch game for the stakeholders. On a shorter time-frame, the ghost in this area, would keep haunting globally, primarily for business in the US market, at least, till the end of this year.

However, for the Indian pharma exporters, pricing appears to be just one among several other critical issues, especially, in the two most lucrative markets of the world. The overall situation in this area, by and large, remains unchanged till today, besides expression of a plethora of good intents.

Thus, pharma analysts’ quest to ferret out an answer to the Gordian knot on the continuity of Indian pharma exporters’ incredible long ride on the ‘gravy train’, has also not been plain sailing, so far. Further mired by the local manufacturers’ prolonging errors of judgement, the status quo ante is expected to still remain elusive, at least, for now.

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. 

Patient Services: No Longer An Optional Competitive Driver

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The emerging global trend of patients’ demand for greater engagement in their treatment decision making process, could well be a game changer in the prescription demand generation process for pharma brands, even in India, and in not too distant future. This would assume a critical importance not just from the patients’ perspective, but also for the pharma companies and other health care players, for commercial success.

The fast penetration of Internet services is increasingly becoming a great enabler for the patients to get to know, learn and obtain more and more information about their fitness, overall health, various illnesses, disease symptoms, available diagnostic tests, including progress in various clinical trials, besides the drugs and their prices – and all these just with several clicks.

Thus, equipped with relevant information from various dependable and user-friendly sources from the cyberspace, patients have started asking probing questions about the risks and benefits of various types of treatment decisions and diagnostics tests, when recommended by the doctors. At times, especially in the Western world, such interactions even lead to changes, additions or deletions in the choice of therapy, including drugs, devices and diagnostics tests.

Even in a developing country, such as India, many of such types of patients would no longer want to play just a passive role in their disease treatment or health and fitness improvement processes. Although, they would continue to want the doctors to take a final decision on their treatment, but only after having meaningful interactions with them.

A 2016 Report: 

An April 2016 report of Accenture titled, “The Patient is IN: Pharma’s Growing Opportunity in Patient Services,” finds that the patients in the top global pharma markets want and expect consistent services coming from the pharma companies.

These patients are increasingly seeking more services from the pharma players before they are treated for a disease, regardless of the types of illnesses they have. However, it’s more important to note that patients’ responses during this survey have clearly indicated that while they highly value the services they use, a vast majority of them do not know about the services, which, as the pharma companies claim, are already available for them.

The Accenture study covered 203 executives at pharmaceutical companies, 100 in the United States and 103 in Europe (8 countries) from October to November 2015, covering seven therapeutic areas: heart, lung, brain, cancer, immune system, bones, and hormones/metabolism. Annual revenues of the surveyed companies ranged from nearly US$ 1 billion to more than US$ 25 billion.

Some important findings:

Following are some key findings of this report:

1. Patient services are delivering value with a significant increase in focus, and investment expected over the next two years, with 85 percent of companies are raising their investment in patient-centric capabilities over the next 18 months. However, the companies have only become slightly more patient-centric over the past two years. 9 of the following top 10 services are attracting above average business impact, which is an increase over hopping 73 percent that currently offer such patient services:

  • Disease education
  • Patient segmentation and insight
  • Patient experience management
  • Medication delivery/support
  • Patient risk assessment
  • Wellness information and health management
  • Nurse/ physician/patient access portal
  • Medication/ treatment reconciliation
  • Patient outreach, reminders, and scheduling
  • Adherence program management

2. Digital platforms play a dominant role in making patients aware of the services offered. Thus, companies are going big with investments in digital engagement technologies and supporting analytics, with 95 percent of companies planning to invest in patient engagement technologies over the next 18 months.

3. Much of this investment (but not all) is aligned to what patients value. 50 percent of the following top 10 fastest growing services are perceived by the patients delivering significant value:

  • Benefit coverage and access support
  • Health coach/counselor
  • Adherence program management
  • Co-payment assistance programs
  • Remote monitoring
  • Affordability and reimbursement support
  • Nursing support services
  • Reward/ incentive programs
  • Medication delivery/support
  • Patient outreach, reminders, and scheduling

Out of these, ‘medication delivery and support’, ‘remote patient monitoring’ and ‘adherence program management’ were highly valued by 85, 79 and 77 percentages of patients, respectively.

To give an example, pharma companies in the United States use digital as the primary channel for direct communications for patients. They use social media (51 percent) and web pages (49 percent) to market patient services. The use of TV is around 53 percent.

The challenge:

Let me re-emphasize here, as on date, just 19 percent of the surveyed patients are familiar with already available services meant for them. This had happened, despite respective pharma companies’ basic reliance and dependence on health care professionals for dissemination of their respective well-targeted services.

Thus, lack of awareness among patients about the services provided, throws a major challenge to pharma players to accurately ascertain, finding out effective ways, and then continuously measure and evaluate the impact of those services on outcomes, to further hone the process. Such a mechanism needs to be put in place before channeling further major investments in this important space.

Key takeaways:

Following are the key takeaways from this study:

  • Patient services will become a competitive driver and are no longer optional for pharmaceutical companies.
  • Investment should be led by what patients value, but measuring business value is critical to sustainability.
  • Clear organizational and operating strategy must be in place to ensure companies are structured for success.
  • Effective communication to patients the economic value of services, is central to healthcare professional interactions.

Patient-services strategy:

Accenture’s North American Managing Director of patient-services epitomized the findings of the report during its release on April 2016 by saying, “In this changing competitive environment, the question will no longer be if life sciences companies should offer these services, but rather which ones, and how they should be implemented.”

Thus, development of a robust patient-services strategy by the pharma players, that syncs well with the patients’ needs on the ground, will be absolutely necessary for the pharma players, as we step into the future. More importantly, there should be an effective alignment of the strategy with different health care professionals, through effective communication of various types and kinds, to ensure that the brand value offerings, well supported by carefully tailored patients’ services, generate a synergistic outcome for the target group.

Conclusion:

Patient services are increasingly assuming importance of a cutting-edge competitive driver of success in the pharma business. Accordingly, various types of such services have already started attracting greater investments, especially in the Western part of the globe, and are soon expected to become a key competitive driver of success in the healthcare market of India too.

However, while crafting an effective patient-services strategy, one-size-fit-all type of approach won’t work. This is primarily because, not just the service requirements would vary within patients or patient groups, the method of the preferred service delivery mechanism would also vary. For example, some patients may prefer to engage with their doctors for this purpose, some others’ preference could well be Internet based interactive digital platforms, or through a smart app available in a smartphone.

Thus, to succeed in this area for business excellence, pharma marketers must find out the most effective ways to offer these services to each types or groups of patients.

Moreover, the patient services strategy should be an ongoing exercise, as the target groups’ needs of the types of services, and preferred delivery platforms for the same would also keep changing over time.

In India too, quite slowly though, but steadily, the process of arriving at treatment decisions for the patients is undergoing a metamorphosis. Taking a fast mover advantage in the country, in a big way and now, would help reaping a rich harvest, in the near future.

Are Indian pharma players too taking note of this shifting paradigm for sustainable 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. 

 

Déjà Vu In Pharma Industry

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It’s happening in the West, and is equally widespread in the Eastern part of the globe too, though in different ways and forms, as both the national and international media have been reporting, consistently. The phenomenon is all pervasive, and directed towards stalling almost all possible future laws and policies that a large section of the pharma industry sees as a potential apocalypse for their business models.

It has a wide reach and covers, for example, the policy-decision makers or possible policy-decision makers in the near future, other policy influencers, many hospitals, and the final interface with the patients – the prescription decision makers.

Although, it affects health care as a whole, in this article I shall focus just on the pharma industry.

Looking West:

While looking at the West, I would cite a recent example from the United States. It’s yet another déjà vu for the western pharma industry.

On August 26, 2016, ‘The Los Angeles Times’ in an article titled, “Drug companies spend millions to keep charging high prices” stated, “Of roughly US$ 250 million raised for and against 17 ballot measures coming before California voters in November, more than a quarter of that amount – about US$ 70 million – has been contributed by deep-pocketed drug companies to defeat the state’s Drug Price Relief Act.”

The Drug Price Relief Act of California, is aimed at making prescription drugs more affordable for people in Medi-Cal and other state programs by requiring that California pays no more than what’s paid for the same drugs by the Department of Veterans Affairs of the United States. It would, in other words, protect state taxpayers from being ripped off.

The report also quoted Michael Weinstein, President of the AIDS Healthcare Foundation saying that industry donations to crush the Drug Price Relief Act “will top US$ 100 million by the election, I’m quite certain of it.” He further added, “They see this as the apocalypse for their business model.”

Looking East:

While citing a related example from the eastern part of the globe, I shall draw one from nearer home – India, as China has already been much discussed on this matter. This particular media report on a wide-spread pharma industry practice, though took place in a different form, as compared to the United States, belongs to the same genre, and captures yet another déjà vu involving the pharma players operating in the eastern world, similar to what’s happening in the west.

India:

On August 30, 2016 a report published in ‘The Economic Times’ titled, “Pharma cos offer freebies to doctors, violate code: MP” quoted a serious allegation of a Rajya Sabha Member of the Parliament on this issue. The MP claims, he has evidence of four drug companies’ recently bribing doctors across India to push their products. These four companies include both large Indian and multinational pharma players, and two out of these four features, among the top five companies of the Indian Pharma Market (IPM).

The lawmaker further said, “I am waiting for the minister’s response on this issue. Nothing has come so far. We also have the names of the doctors who have taken bribes, which we will release eventually,”

Another September 06, 2016 report, published by the same business daily in India, categorically mentioned that TOI has documents to establish that one of these companies took hundreds of doctors from across India to places like Vancouver, Amsterdam, Oslo, Venice, New York, Boston, Brussels and Moscow. The documents reportedly include email exchanges between the company executives, city-wise lists of doctors with ‘legacy codes’, names of spouses, passport copies and visa copies, and show how the company has spent several millions of rupees in taking doctors and sometimes even their spouses, ostensibly to attend medical conferences.

Other NGOs have also reportedly submitted proof of the same to the Government for remedial measures in India, against such gross ongoing unethical practices in pharma marketing.

It is worth mentioning here that all these expenses are part of the marketing budget of a company and the sum total of which is built into the ‘retail price to the patients’ of the respective drugs, even in India.

Two broad processes for the same goal:

Thus it emerges, very broadly, there are two key processes followed by many in the pharma industry to achieve the same goal of increasing profit. These are as follows:

  • Marketing malpractices in various forms to influence prescription decision
  • Arbitrary increase of drug prices, for both branded and generic medicines

The justification:

Many global pharma majors still keep justifying, though the number of its believers is fast dwindling, that the high new drug prices have a linear relationship with the cost of new drug innovation. Even for argument’s sake one nods in favor, the critical question that needs to be answered is, if this is the basic or primary axle on which the wheel of innovation moves, won’t affordability and access to drugs for a significant number of the population be seriously compromised?

If not, why is this furor, across the world, is fast assuming a snowballing effect? Why are even the generic drug prices going up steeply even in the United States, where some of the largest Indian drug manufacturers are being questioned for the same by the competent authorities of the country?

I deliberated on a similar subject in my article titled, “The Next Frontier: Frugal Innovation For High-Tech Drugs”, published in this Blog on May 20, 2016.

Marketing malpractices:

Laws are fast catching up to book the offenders resorting to pharma marketing malpractices in most of the countries of the world, including China. This is vindicated by the fact that global pharma players are now paying billions of dollars a fine, in various countries, especially in the West.

Just as no criminal law can totally eliminate any crime, anywhere in the world, despite a heavy dent in pharma’s reputation related to this area, many companies still continue to indulge in such malpractices, blatantly, and even with some brazenness.

India:

Unfortunately, in India, the inertia to catch the bull by the horn and lack of governance in this regard continues, making patients pay a heavy price. As the above media report indicates, both MNCs and the local players indulge into this deplorable activity almost without any inhibition. As many industry watchers believe, some companies have started hiring these services through professional third parties just to create a facade for taking the high moral ground, as and when required, both with the government and also other stakeholders.

Initiating a step in this direction, on December 12, 2014, the DoP announced details of the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’, which became effective across the country from January 1, 2015. The communique also said that the code would be voluntarily adopted and complied with by the pharma industry in India for a period of six months from the effective date, and its compliance would be reviewed thereafter on the basis of the inputs received.

UCPMP, though not a panacea, was aimed at containing pharma marketing malpractices in India. However, as happened with any other voluntary pharma marketing code, be it of a global drug major or their trade associations, similar non-compliances were detected even by the DoP with voluntary UCPMP.  This gross disregard to the code, apparently prompted the DoP contemplating to make the UCPMP mandatory, with legal implications for non-compliance, which could possibly lead to revocation of marketing licenses.

In this context, it is worth recapitulating that the Union Minister of Chemicals and Fertilizer – Mr. Ananth Kumar, in his reply in the Indian Parliament, to a ‘Lok Sabha Starred Question No: 238’ on the UCPMP based on the inputs received, also had admitted:

“The Government had announced Uniform Code for Pharmaceutical Practices (UCPMP) which was to be adopted voluntarily w.e.f. 1st January, 2015 for a period of six months and has last been extended up to 30.06.2016. After reviewing the same it was found that the voluntary code was not working as expected. The Government consulted the stakeholders, including NGO’s / Civil Society members and after examining their suggestions it is now looking into the viability of making the Code Statutory.”

This seems to be yet another assurance, and expression of a good intent by the Union Minister. The fact today is, after extending the UCPMP in its original form up to June 30, 2016 with four extensions and despite the Government’s public admission that it is not working, by a circular dated August 30, 2016, the Government has informed all concerned, yet again, that voluntary UCPMP has now been extended ‘till further orders’.

This not only creates public apprehension on the DoP’s true intent on the subject, but also gives enough room for speculation regarding behind the scene power play by the vested interests to keep a mandatory UCPMP, having sufficient legal teeth, away, as long as possible. Are these forces then also visualizing its enforcement as an apocalypse for their business models in India too?

Thus, the possibility of containing pharma marketing malpractices in India is still charting in the realm of the decision makers’ assurances and no further.

Arbitrary drug price increases:

Arbitrary price increases of important drugs are drawing increasing public ire in the West, the latest being a 400 percent price increase of generic EpiPen of Mylan. This is now being considered yet another business malpractice in the pharma industry, as whole.

No robust regulatory or legal measure is now being followed in the West to contain the drug over pricing public health menace. Thus, it is increasingly assuming a critical political significance today to win over the voters, especially in the forthcoming Presidential election of the United States.

Thus, as reported by Reuters, on September 02, 2016, Hillary Clinton announced that, if elected, she would create an oversight panel to protect the consumers of the United States from large price hikes on longer-available, life-saving drugs and to import alternative treatments if necessary, adding to her pledges to rein in overall drug prices.

She would give the ‘Oversight Panel’ an aggressive new set of enforcement tools, including the ability to levy fines and impose penalties on manufacturers when there has been an unjustified, outlier price increase on a long-available or generic drug.

On September 08, 2016, reacting to these proposed measures articulated by Hilary Clinton, the global CEO of the world’s largest pharma player reportedly commented, as expected, that it “will be very negative for innovation.”

Nonetheless, the bottom-line is, even in the United Sates, a transparent mechanism to deal with arbitrary price increases of the existing important medicines, still charts in the realm of several assurances of the probable decision makers, just as it is India to effectively deal with pharma marketing malpractices.

A global CEO’s lone voice stands out:

In this context, I would start with yet another example of astronomical price increase of a widely used anti-diabetic product, besides EpiPen of Mylan. According to Dr. Mayer Davidson, Professor of Medicine at the Charles R. Drew University of Medicine and Science in Los Angeles, who has carefully tracked the rapid and repeated increases, from 2011 to 2013 the wholesale price of insulin went up by as much as 62 percent in the United States. Whereas, from 2013 to 2015 the price jumped again, from a low of 33 percent to as much as 107 percent.

In the midst of this scary situation, a solitary and apparently a saner voice from the global pharma industry stands out. According to an article published in the Forbes Magazine on September 06, 2016, Brent Saunders, CEO of Allergan, ‘explicitly renounced egregious price increases.’ Saunders also said that the industry needs to ‘end its addiction to price hikes far in excess of inflation, often taken several times in a single year.’ While outlining his company’s “social contract with patients,” Saunders vowed that Allergan would:

  • Limit price increases to single-digit percentages, “slightly above the current annual rate of inflation,” net of rebates and discounts.
  • Limit price increases to once per year.
  • Forego price increases in the run-up to patent expiration, except in the case of corresponding cost increases.

Though this seems to be a lone voice in the pharma industry, it makes the CEO stand much taller than his peers.

India:

On this score, India has already put in place the ‘National Pharmaceutical Pricing Authority’ to regulate the drug prices of primarily those falling under the ‘National List of Essential Medicines (NLEM)’. However, it is a different matter that as per its own public admission, NPPA is still unable to strictly enforce these price controls, with significant incidences of non-compliance. Therefore, the net benefits to the patients in India for having this mechanism, is indeed arguable.

The core issue:

All that we witness in this area are mostly assurances, promises and good intent on the part of various Governments of different political dispensation, over the last several decades. The same indifference to public health care, in general, continues. Nothing seems to be working effectively in the public health care space of the country, even today. A large section of patients, bearing the tough burden of the highest out of pocket health expenditure in India, are under significant consequential stress of all kinds.

An important part of this scenario is well-captured in the statement of the erstwhile Secretary of the Department of Pharmaceuticals (DoP) – V K Subburaj at an event in New-Delhi on April 19, 2016, when he said, “In the entire world, I think our drug control system probably is the weakest today. It needs to be strengthened.”

Is it a legacy? Possibly yes. But, who will fix it, and what steps are we taking now for its satisfactory resolution?

The core issue in the pharmaceutical arena is, therefore, about striking an optimal balance between drug profitability and patient affordability, to avoid any adverse impact on access to drugs for a large majority of population in the world.

Conclusion:

Thus, it appears to me, if those who now decide for the people’s health interest, also refuse to wake up from deep slumber and remain as indifferent as before, soon we may hear or read or experience yet another or more of similar deplorable developments, having serious adverse repercussions on the patients.

Interestingly, despite such incidents, pharma stocks remain generally unaffected and buoyant. Its overall trend continues heading north, factoring-in that no implementable Government action is forthcoming, for obvious reasons. Consequently, pharma business remains as robust as ever, but the patients continue to suffer increasingly more.

Pharma industry in general, has been seriously attempting to wash its hands off for this scary emerging situation, since long. It blames the governments for trying to throttle the money spinning business with ‘unnecessary’ regulations, as discussed above, for something that is only the state responsibility, as they perceive. The governments, in turn, blame the industry and try to regulate it more strictly. Invariably, the patients in need of right and affordable medical care get caught in this cross-fire – some succeed to overcome the health crisis, but mostly exposing themselves to huge financial uncertainty in the future, many others can’t.

When the business continues to flourish with current business ‘practices’, why would the pharma players bother about rapidly tarnishing industry reputation, and public outcry? Does it really matter at all on the ground, for running a money spinning business machine, especially when there exists a fair chance of stalling the new laws and policies, with deep pockets, as alleged by many?

In this scenario, what else a common man would do while falling seriously ill, except praying to the almighty for divine care and blessings for a speedy recovery, along with possibly lamenting, it’s déjà vu in the pharma industry?

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. 

At The Indian IPR Front: ‘Ground Control, There’s No Major Storm’

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The incessant pressure of the developing countries on India, from 2005 to date, to include various restrictive conditions in the Indian Patents Act 2005, still continue. This demand spans across the inclusion of even those provisions, which many experts term as TRIPS-Plus, as these are not required by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. More interestingly, the pressure group also insists on the simultaneous deletion or dilution of some existing important provisions in the statute that guarantee public health interest of the nation.

This pressure is expected to mount in the G20 summit of September 4-5, which is now being held in China.

Refreshingly, on 30 August 2016, just ahead of this summit, the eminent economist Dr. Arvind Panagariya, who is also the incumbent Vice Chairman of Niti Aayog of India, and India’s Sherpa at the G20 summit reiterated, as follows, in an interview to a leading National English Business Daily:

“India has strongly opposed the language of the draft on Intellectual Property Protection (IPR) to be taken up at the upcoming G20 meeting in Beijing.”

In the interview, having re-emphasized the critical point that “there is a certain flexibility that we have under the TRIPS agreement and anything that dilutes that flexibility is not acceptable to India,” Dr. Panagariya clearly reaffirmed, yet again that ‘Indian IPR laws and policies are absolutely TRIPS compliant’.

This statement indeed sends a very positive signal to all on the ground, regarding the robust position maintained by the Government, to ward off any move by the overseas vested business interest to derail the flexibility that Indian well-balanced patent regime offers today, not just for public health, but also to foster innovation ecosystem in the country.

At the same time, India’s Sherpa at G20 summit also reportedly clarified that the IPR framework being proposed at the G20, in its strictest sense, cannot be construed as TRIPS-Plus. Nevertheless, some language used in the proposed G20 draft could be subject to interpretation, and India feels that it should not leave any room for ambiguity that has the potential to stretch this demand further, as we move on.

According to Dr. Panagariya: “Right now, these documents have some language where people in the Department of Industrial Policy & Promotion (DIPP) feel that it impinges a bit. We have to fight it out at the summit.”

The basis of apprehension:

There are many reasons for the recent apprehension that India may buckle under the US pressure to dilute its IP laws and policies. One of the reasons could well be a possibility that India has come to an understanding with USTR in this area.

An interesting article published in the ‘spicyip’ on March 14, 2016 also captured this scenario pretty well. I am reproducing below in verbatim a paragraph of this paper, just as an example:

“Last month, the Indian government privately assured the US-India Business Council (“USIBC’’) that it would not invoke compulsory licensing for commercial purposes, as reported in their submissions (available here) to the United States Trade Representative (“USTR”) for the 2016 Special 301 Review. The USIBIC stated that it would be “further encouraged” if the government of India were to make a public commitment, or a written declaration to only issue compulsory licenses in the event of public health emergencies, and not for commercial purposes. This, in their eyes, would “greatly enhance legal certainty for innovative industries”. While such a private assurance doesn’t give rise to any legal commitments, it may well be indicative of a policy shift.”

Prior to this, among many others, a March 3, 2016 ‘The Wire’ report captioned “India Assures the US it Will Not Issue Compulsory Licenses on Medicines”, also raised the same red flag.

The pressure continues even post engagement:

Be that as it may, America has been, repeatedly, raising its concerns over India’s patent regime, driven by its powerful pharma lobby groups.

To keep the kettle boiling, the Office of the United States Trade Representative (USTR) in its 2016 Special 301 Report released this year on April 12, continued to keep India, along with 11 countries, on the Priority Watch List (PWL) for the current year.

USTR reportedly expressed serious concern about Indian IP policies stating that the regime apparently ‘favor’ indigenous manufacturing or Indian innovators. It also alleged that such direction ‘damages’ the patent infrastructure not just in India, but across the world.

It is believed by many that the Special 301 Report is, in fact, a formal posturing of the country on their unilateral IP related business hurdles for the year, exhibiting the power to implement unilateral trade sanctions when the US demands are not met.

In that context, the 2016 Special 301 Report caught many by surprise, as the Indian ‘IPR Think Tank’ (a body of the Union Government-selected experts) was also working closely with the United States to identify and address their issues of concern, such as, patent system, copyright infringement, trademark and counterfeiting, among others.

At that time, this discussion was possibly in its final stage as, just a month after, on May 12, 2016, the Union Cabinet approved the National Intellectual Property Rights Policy (IPR) of India, as proposed by the ‘Think Tank’, in consultation with, among others, especially the United States, which reportedly expressed its overall satisfaction with the final IPR policy.

Key concerns:

From the pharma industry perspective, the key IP concerns are centered, primarily, in the following three areas, besides a few others:

  • Patentability
  • Compulsory Licensing (CL)
  • Data Exclusivity

I would, therefore, concentrate briefly on these three areas to argue how reasonable is the Indian Patents Act 2005 to create a win-win situation both for the patients and the industry while fostering pharma innovation in the country.

Patentability:

One of their key concerns on patentability, revolves round an important provision in the statute – Section 3 (d).

Pharma Multinational Corporations (MNCs), and their trade associations have been going overboard, since long, to lobby hard to make all concerned believe that section 3 (d) is a stumbling block for pharma innovation, as it does not allow patent protection on known chemical substances lacking any significant improvement in clinical efficacy.

This provision of the statute prevents ever-greening of patents with frivolous incremental innovation. Consequently, it blocks the possibility of pricing such ‘me too’ new molecules, exorbitantly, and persuading the prescribers of the existing molecule switching over to the new brand, backed by contentious marketing campaigns, adversely impacting affordability and access to the majority of the patients in India.

Notwithstanding the shrill voices of vested interests, Section 3 (d) has been upheld by the Supreme Court of India in the famous Glivec case of Novartis against Cipla.

The Submission of the Federation of Indian Chambers of Commerce and Industry (FICCI) to USTR for the Review of ‘2016 Special 301 Report’, categorically also states that the Indian Patent Act prescribes a higher threshold on inventive step for medicines, which is in keeping with the TRIPS Agreement, Paris Convention and the Doha Declaration. Hence, Section 3 (d) is sound in terms of the TRIPS, Public policy and Health policy.

Compulsory License (CL):

Besides the hard fact that India has, so far, granted just one CL in a span of more than the last ten years, the Doha Declaration on the TRIPS Agreement related public health clearly provides the flexibility to all its member states to decide on the necessary grounds for granting CL. It is noteworthy that for public health interest, TRIPS flexibilities for CL has been used even by the developed countries, such as, Canada, United States and Germany, in the not too distant past.

Data exclusivity:

The terminologies ‘Data Exclusivity’ and ‘Data Protection’ are quite often used interchangeably by many, creating a great deal of confusion on the subject. However, in a true sense these are quite different issues having a critical impact on the public health interest of a nation.

In an article published in ‘ipHandbook’, titled “Data Protection and Data Exclusivity in Pharmaceuticals and Agrochemicals”, the author Charles Clift, a former Secretary, Commission on Intellectual Property Rights, Innovation and Public Health, World Health Organization; differentiated these two terminologies as follows:

Data Protection (DP): Protection of commercially valuable data held by the drug regulator against disclosure and unfair commercial use.

Data Exclusivity (DE): A time bound form of Intellectual Property (IP) protection that seeks to allow companies recouping the cost of investment in producing data required by the regulatory authority.

According to Charles Clift, Article 39.3 only articulates widely accepted trade secret and unfair competition law, and is not an invitation to create new IP rights, per se, for test data. Nor does it prevent outside parties from relying on the test data submitted by an originator, except in case of unfair commercial practices.

Some developed countries, such as the United States and the European Union have argued that Article 39.3 of TRIPS requires countries to create a regime of DE, which is a new form of time-limited IP protection. However, it is worth noting that in both these countries DE regime was adopted prior to the TRIPS Agreement. Hence, many experts construe such approaches and pressure, thus created for DE, as ‘TRIPS-Plus’.

In its new IPR Policy, India has successfully resisted the demands of TRIPs-Plus provisions, such as, data exclusivity, patent linkage and patent-term extension.

Even the draft IPR policy had reiterated that India accepts: “Protection of undisclosed information not extending to data exclusivity.”

Any near-term possibility of a change in the statute?

While the new IPR Policy of India focuses on consolidating institutional mechanisms to create a robust IPR ecosystem in the country, besides resolving some pressing issues, such as, expediting approval processes involving patents or trademarks, it does not indicate any possible change in the important provisions in the Patents Act 2005, including the much talked about Section 3 (d) and compulsory licensing, despite concerns expressed by the US and pharma companies.

Moreover, a May 13, 2016 Press Trust of India (PTI) report on the Union Cabinet approval of Indian IPR Policy quoted a Government official, as follows, negating the apprehensions that the government may yield to the pressure of developed countries with regard to its IR regime:

“India will never go beyond its current commitments in the TRIPS. Section 3 (d), patent linkage, data exclusivity and compulsory licensing are red lines.”

On the same day and in the same context, Union Finance Minister Arun Jaitley also reportedly stressed that India’s IPR policies are TRIPS-compliant and encourage invention of life-saving drugs, while at the same time, “we must also be conscious of the need to make it available at a reasonable cost so that drug cost does not become prohibitive as has become in some parts of the world”, he articulated, unambiguously.

Conclusion:

Despite all these developments, reiterations and interpretations, a lurking fear on India’s diluting the current patent regime of the nation was refusing to die down in the country.

Many experts were also quite apprehensive about what would be India’s stand on IP in the G 20 summit on September 4-5, currently being held in China.

Is it, then, just a storm in a tea cup on the ground?

This is not a very easy question to answer, though, as many industry watchers sense. Nonetheless, yet another emphatic statement on the subject coming from a top Government echelon and none other than Dr. Arvind Panagariya, the Vice Chairman of Niti Aayog and India’s Sherpa at G20 summit, possibly sends a clear message, at least for now, to all those holding ground in the Indian IPR front:

‘Ground Control, There’s No Major Storm’.

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. 

Pharma In 2016 Rio Olympics

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On August 4, 2016, the ‘Adweek’ – a well-known weekly American advertising-trade publication, reported that even a day before the games began, the national ad sales revenue of just one major network in ‘2016 Rio Olympics’ had set a new record for itself, exceeding a never before turnover of US$ 1.2 billion. This figure is believed to be the most of any network for any media event in the history of the United States, and includes broadcast, cable and digital advertising.

The strongest advertising categories include automotive, beverages, telecommunications, insurance, movie studios and pharmaceuticals, as the advertisers were exceptionally bullish on Rio Games, the report highlighted.

Another report, published in the August 9, 2016 edition of ‘U. S. News’, states that the Democratic presidential nominee Hillary Clinton also aired US$ 13.6 million in campaign commercials during this Olympic games, far exceeding her nearest rival, seeking to reach the millions of television viewers who can’t skip past the commercials as they watch live coverage of the Olympics. This example underscores the perceived importance of Olympic events to various types and genres of advertisers.

My article will focus on this new found interest of many global pharma companies, their level of participation, with an idea of approximate expenditure to be incurred to run various types of ad campaigns in such well-awaited global events, held once in every four years.

The key advantages and the potential:

One of the key advantages of advertisements during Olympic games is their much larger captive audience and eyeball grabbing power, in every respect, both global and local. This, in turn, offers an attractive opportunity to the advertisers to exploit its immense potential for shaping and re-shaping public opinion and preferences, on various target areas.

Probably for this reason, a wider spectrum of new advertisers, including pharma players have now started favoring this event more than ever before.

Entry of pharma:

According to available reports, about 20 pharma brands and companies ran 293 TV ads during the coverage of Rio Olympic games. Some of these companies ran brand advertisements, while some others selected non-brand disease awareness campaigns, or in a very few instances – both.

According to real time TV ad tracker iSpot.tv, pharma contributed US$ 45 million and occupied the mid-space of the table for blockbuster TV advertisers, during the 17-day Rio events.

Two types of marketing strategies followed:

In Rio Olympics pharma companies had opted for primarily two different types of marketing strategies, as follows:

  • Product branding
  • Corporate branding, mainly through disease awareness

Global majors such as, Pfizer (for pain management – Lyrica and anti-inflammatory – Xeljanz), Novo Nordisk (Antidiabetic – Victoza), Bayer and Johnson & Johnson (anticoagulant – Xarelto) and Lundbeck and Takeda (antidepressant – Trintellix), appeared to be brand focused.

Whereas, companies such as, Merck and Mylan were disease awareness focused. Pfizer seemingly opted for both product branding and R&D focused corporate branding.

‘Product Branding’ versus ‘Corporate Branding’:

Product branding is defined as a marketing strategy wherein a business promotes and markets an individual product without the company name being at the center in the advertising campaigns.

Corporate branding, on the other hand, is broadly defined and explained as, the practice of promoting the brand name of a corporate entity, as opposed to specific products or services. The activities and thinking that go into corporate branding are different from product and service branding, because the scope of a corporate brand is typically much broader.

The success parameters:

A product branding is considered successful when it pushes up both the top and the bottom lines of the brand, with a commensurate increase in its top of mind recall and market share.

Whereas, a corporate branding is considered successful, when consumers hear or see the name of the company they will associate with a unique value and positive experiences. No matter what product or service the corporation offers, the corporate name is always an influence.

If I am to cite just one example out of many, and outside the pharma industry, I would say, ‘Apple’ has been established as a powerful corporate brand that focuses on the strength of its name as much as the features of any ‘Apple’ products.

Thus, for any successful corporate brand, the name would immediately evoke a positive reaction in the consumers’ mind, without any detailed list of product features, and for which many consumers would be willing to pay even a premium price, without any grudge or grumble.

Those who kept away from hard selling of a brand:

In Rio Olympics, as stated above, according to recent reports, some large pharma companies, interestingly, preferred to keep themselves away from hard selling of any of their brands. They, on the contrary, chose to make use of this powerful event to facilitate much wider public engagement with important and interesting health issues, like disease awareness, through craftily produced TV clips. The key intent is, of course, enhancing their corporate image to the public at large, for sustainable and long term business excellence.

A few such examples, as witnessed during Rio Olympics, are as follows:

  • Merck ran an eyeball grabbing, top class and emotional disease awareness ad for HPV vaccinations.
  • Mylan ran its “Face Your Risk” ad. This clip advises people with allergens to talk to their doctor about a prescription treatment for severe reactions, because every six minutes, someone with life-threatening food allergies is sent to the hospital.

Pfizer, in addition to brand promotion, also ran an interesting, yet fact based campaign, titled “Before it Became a Medicine”. This ad narrates an emotive story of bringing a medicine to life, which is no different from any other process of creation. It requires innovation, imagination, and restless perseverance in the face of obstacles, both expected and unforeseen.

One is a double-edged sword:

Strong high profile brand promotion in the global events such as Rio Olympics, could well be perceived as a double edged sword, having both the up and the downsides.

The upside is of course a strong boost in the sales and profit of the concerned brands. However, there is also a significant downside. When the details of huge pharma marketing expenditure, just on TV ads and also for only a 17- day event though important, would come to public knowledge, it could add more fuel to the fire on the ongoing public criticism towards humongous marketing expenditure, incurred by some pharma players, which at times exceeds the same for even R&D.

This is important, as a very large number of different stakeholders, including the patients, firmly believe that such ‘unnecessary’ expenditures on brand marketing, are ultimately passed on to the final consumers or the payers in terms of high pricing of those brands. Whereas, the possibility of triggering such type negative public opinion, with similar ads and during the similar events, with corporate brand or disease awareness campaigns, I guess, would be rather slim or improbable.

Let me hasten to add, I strongly believe that sales and marketing are absolutely necessary for pharma brands, just as any other branded consumer durables or non-durables. Nevertheless, I would also not brazenly ignore the prevailing reality, and the public optics associated with this sensitive issue, in any way.

How much does it cost?

To answer this question, I would try to give just a feel of the type of deep pocket that an interested pharma advertiser would require to have to get involved on such interesting ball game. During Rio Olympic games, the top three high spending pharma brands, reportedly, were as follows:

  • Pfizer (the pain medication Lyrica): US$ 9.1 million
  • Pfizer (the anti-inflammatory Xeljanz): US$ 5.7 million
  • Novo Nordisk (GLP-1 diabetes treatment Victoza, which featured Olympic gold medal basketball player Dominque Wilkins): US$ 9.2 million

It is worth noting that the top spending brands for consumer product such as Chrysler, spent US$ 25 million on one commercial, along with US$ 15.2 million on another. Similarly, Samsung spent US$ 17.1 million on one ad and US$ 12 million on another one.

Is there any right approach?

Instead of trying to pontificate on what sort of approach is right or wrong for pharma companies in these global events, I would only elucidate, what type of marketing approach could possibly be able to create and leave a stronger and long term residual impact on the viewers’ mind, considering the prevailing global scenario and the general sentiment towards the pharma companies, in general.

I reckon, in the events like the Olympics, it is possible for a pharma player to reap a rich harvest and get a long-term dividend with media outreach, carefully keeping away from hard-selling of clearly identifiable brands. The well-created campaigns may focus primarily on the softer aspects of public health care, such as, caring for patients, disease awareness, making life more enjoyable while fighting a disease, bringing newer drugs for better life, or even achievements in the space of corporate social responsibility.

Conclusion:

Global events such as Rio Olympics, could be well leveraged by the individual pharma players, especially to revamp the generally declining public image for greater overall business predictability and sustainability.

The types of corporate branding that some of us had witnessed in Rio Olympics, have the potential to significantly help achieving this objective.

The realization of the fast declining negative public image of pharma, in general, appears to have dawned on its global trade organizations only now. This has indeed been a long saga, though many pharma players still ignore it, rather unabashedly.

The broader impact of the creation of a positive and robust corporate public image with direct connects with consumers through the relevant ads such as on diseases awareness, could be profound, also for a sustainable business growth, even in a country like India.

Thus, the entry of pharma companies in the widely viewed global events, such as the 2016 Rio Olympics, unravels yet another new strategic platform for many other players. Its multiple judicial use, in tandem with other business blueprints, could facilitate the industry to effectively neutralize and navigate through the strong headwind of negative public perception, while managing the challenge of change.

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. 

 

Cancer Care: Dawns A New Era Of Precision Medicine In India

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The concept of ‘Precision Medicine’ has started gaining increasing importance, in the treatment process of many serious diseases, such as cancer. It is now happening in many countries of the world, including India.

The National Institutes of Health (NIH) of the United States, describes ‘Precision Medicine’ as:

“An emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.”

This is quite in contrast to the widely practiced “one-size-fits-all” type of drug treatment approach, where disease treatment and prevention strategies are developed for the average person, with less consideration for the differences between individuals.

It continues, irrespective of the fact that the same drug doesn’t always work exactly the same way for everyone. It can be difficult for a physician to predict, which patient will benefit from a medication and who won’t, besides having any advance inkling on who will experience Adverse Drug Reactions (ADR) with it, and who will not.

Whereas, the treatment path of ‘Precision Medicine’ allows doctors to predict more accurately which treatment and prevention strategies will work most effectively for a particular disease, and in which groups of people. This is mainly because, ‘Precision Medicine’ looks at the root cause of the ailment for each patient.

For example, in cancer care, use of the term ‘Precision Medicine’ would mean a treatment process for patients with similar tumors, that has been immaculately worked out in accordance with their unique genetic, physical, psychosocial, environmental, and lifestyle factors. Thus, especially for the treatment of life-threatening diseases, a gradual shift from “one-size-fits-all” types of medicines to ‘Precision Medicines”, could bring a new hope of longer survival or remission, for many such patients.

For example, in precision cancer care, it is all about analyzing a patient’s tumor to determine with specificity what drug or combination of drugs will work best with least side effects for that particular individual.

In this article, I shall focus on the development, use and benefits of ‘Precision Medicine’ in cancer, especially in India.

Not a radically new concept:

Several examples of ‘Precision Medicine’ can be found in a few other areas of medicine, as well, though its use in everyday health care is not very widespread, as on date.

One such example can be drawn from the blood transfusion area. A person requiring it, is not given blood from a randomly selected donor. To minimize the risk of any possible post-transfusion related complications, the blood for transfusion is selected only after scientific confirmation that the donor’s blood type matches to the recipient.

Difference between ‘Precision’ and ‘Personalized’ Medicines:

There is a significant overlap between these two terminologies. According to the National Research Council (NRC) of the United States, ‘Personalized Medicine’ is an older term having a meaning similar to ‘Precision medicine’, but may not always be exactly the same.

This change was necessitated as the term ‘Personalized’ could be interpreted to imply that treatments and preventions are being developed uniquely for each individual. Whereas, in ‘Precision Medicine’, the focus is on identifying which approaches will be effective for which patients based on genetic, environmental, and lifestyle factors, as stated above. The NRC, therefore, preferred the term ‘Precision Medicine’ to ‘Personalized Medicine’ to avoid such confusions or misunderstandings. Nevertheless, these two terms are still being used interchangeably.

Another terminology – ‘Pharmacogenomics’ is also used by some, in the same context, which is, in fact, a part of ‘Precision Medicine’. According to National Library of Medicine, United States, Pharmacogenomics is the study of how genes affect a person’s response to particular drugs. This relatively new field combines pharmacology (the science of drugs) and genomics (the study of genes and their functions) to develop effective, safe medications and doses that will be tailored to variations in a person’s genes.

Global initiatives taking off:

Currently, in various parts of the world, there are many initiatives in this area. However, one singular state sponsored initiative, I reckon, is exemplary and stands out.

According to NIH, in early 2015, President Obama announced a research effort focusing on bringing ‘Precision Medicine’ to many aspects of health care. The President’s budget for fiscal year 2016 included US$216 million in funding for the initiative for the NIH, the National Cancer Institute (NCI) – the NIH institute focused on cancer research, and the Food and Drug Administration (FDA).

‘The Precision Medicine Initiative’ has both short-term and long-term goals:

  • The short-term goals involve expanding precision medicine in the area of cancer research. Researchers at the NCI hope to use this approach to find new, more effective treatments for various kinds of cancer based on increased knowledge of the genetics and biology of the disease.
  • The long-term goals focus on bringing ‘Precision Medicine’ to all areas of health and healthcare on a large scale.

The market:

According to a July 2016 research report by Global Market Insights, Inc., the ‘Precision Medicine’ market size was over US$39 billion in 2015, and has been estimated to grow at 10.5 percent CAGR from 2016 to 2023, expanding the market to US$ 87.79 billion by end 2023.

The demand for ‘Precision Medicine’ is expected to significantly increase, specifically in cancer treatments, and also would be driven by advancements in new healthcare technologies, and favorable government regulations, in this area.

Faster US regulatory approval:

According to an August 15, 2016 article, published in the ‘MedCity News’ – a leading online news source for the business of innovation in health care, companion diagnostics, this trend is gaining currency as novel drugs are being paired up with tests that determine which patients will have a higher chance of responding to that drug.

This is vindicated by an expert analysis of a recent study, which found that the probability of a drug approval jumped three-times to 25.9 percent of those drugs that were approved with a predictive biomarker, from 8.4 percent for drugs without one.  This means a threefold increase in success, as determined by FDA registration, if any pharma or biologic drug company had a predictive marker in its new product development strategy. This indication would expectedly encourage more drugs to come with companion diagnostics than without, as the analysis underscored.

The National Institutes of Health (NIH) of the United States defines ‘Biomarkers’ or ‘Biological Markers’ as, “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological responses to a therapeutic intervention.”

‘Precision Medicine’ in India:

In the Indian health care space, ‘Precision Medicine’ is still in its nascent stage. This is despite its need in the country being high, especially while treating life threatening ailments, such as cancer, with greater precision, predictability and, therefore, more effectively than at present.

In several focus group studies too, the local medical specialists have also concurred with the global estimation of the inherent potential of ‘Precision Medicine’, as it rapidly evolves in India, particularly for use in oncology.

Local research:

Studies related to ‘Precision Medicine’ have already commenced, though in a modest scale, in a number of Government research centers, such as, Centre for Cellular and Molecular Biology (CCMB), Indian Council of Medical Research (ICMR), National Institute of Biomedical Genomics (NIBMG) and Institute of Genomics & Integrative Biology (IGIB).

Some large Government Hospitals too, like, All India Institute of Medical Sciences (AIIMS), National Institute of Mental Health and Neurosciences (NIMHANS), and even in Tata Memorial Hospital are making good progress in this area.

Local potential and market impact:

In March 2016, a leading daily of India had reported with examples that oncologists have started using ‘Precision Medicine’, in the country.

In this report, a molecular geneticist was quoted saying, “We see patients with blood, breast, lung, and colon cancer being referred for genetic testing on a routine basis. This testing is either for predictive purposes or for precision medicine guidance, where genetic tests are increasingly being used to determine which drug may be used for treatment.”

“We have had more than a few cases where patients respond well after being put on a new drug based on the results of these tests,” the expert said.

According to a May 2016 report of the Indian Council of Medical Research (ICMR), in the year 2016, the total number of new cancer cases is expected to be around 14.5 lakh (1.5 million), and the figure is likely to reach nearly 17.3 lakh (1.7 million) of new cases in 2020.

Over 7.36 lakh (736,000) people are expected to succumb to this disease in 2016 while the figure is estimated to shoot up to 8.8 lakh (880,000) by 2020. The data also revealed that only 12.5 percent of patients come for treatment in early stages of the disease.

Taking note of this fast ascending trend, it would be quite reasonable to expect that treatment with ‘Precision Medicine’, using advanced genetic profiling, would catch up, and grow proportionally in some section of the population, sooner than later. This trend is expected to keep pace with the commensurate increase in the anti-cancer drug market of India.

In tandem, the demand for preventive measures, especially, for cancer, cardiovascular, psychosomatic and many chronic metabolic diseases at the onset or prior to even onset stages, based on genome-based diagnostics, are also expected to go north. This would primarily be driven by increasing health awareness of the younger generation of India.

The spin-off commercial benefits for the pharma and diagnostic players in India, competing in these segments, could well be a significant boost even in the market potential of the older generic drugs in new patient groups, prompted by many out-of- box diagnostic and disease treatment strategies.

Another interesting article on genomic diagnostics for ‘Precision Medicine’, published on March 15, 2016 by ‘Pistoia Alliance’ – a global, not-for-profit alliance in life science that aims at lowering barriers to innovation in R&D, also expressed similar views regarding the future potential of ‘Precision Medicine’ in India.

Some key strategic steps:

Taking proactively some key strategic steps for business planning and development by the domestic pharma and diagnostic players, is now more important than ever before. This may call for developing some critical studies that would accelerate working out novel strategies for ‘Precision Medicine’ in India, besides obtaining required regulatory approvals in the coming years. The studies may include, among others:

  • Detailed analysis of target patient populations
  • Their genetic makeup for different types, or sub-types of diseases
  • Addressable sub populations
  • Their current treatment strategies, costs, affordability and differentiated value offerings of each, if any.

Conclusion:

Genomic research in India is now mainly directed towards routine genome-based diagnostics for a number of conditions, mostly for cancer. The country needs to encourage taking rapid strides to first sharpen and then gradually broaden this area, in various ways, for more effective and predictable treatment outcomes with ‘Precision Medicine’. As on date, most of such studies are carried out in the United States and Europe.

Alongside, a robust regulatory framework is required to be put in place, for wider usage of ‘Precision Medicine’ in India, without causing any concern to stakeholders. Government should also explore the need of clearly defining, and putting in place transparent, patient-friendly and robust Intellectual Property (IP) policies in the ‘Precision Medicine’ related areas to encourage innovation.

Healthcare expenditure being out-of-pocket for a vast majority of the population in India, the additional cost to be incurred for genomic sequencing tests, still remains a huge concern for many. Nevertheless, the good news is, many players have now gradually started entering into this area, spurring a healthy competition. This process would also gain accelerated momentum, as we move on.

This is just a dawn of a new era of ‘Precision Medicine’ in India. Its rapid development, is expected to be driven by a large number of startups, equipped with state-of-art technology, and hopefully, with greater health insurance penetration and the support from the Government. All this would bring the ‘Precision Medicine’ treatment cost affordable to a sizeable section of the population in the country, particularly for the treatment of cancer. The evolving scenario appears to be a win-win one, both for the patients, as well as the pharma and diagnostic players in 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.