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Pharma R&D: Chasing A Rainbow To Replicate The Past

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Would future be always a replica of the past?

If the response is yes, the efforts of many global pharma players to replicate the successful Research and Development (R&D) models of long gone by days, would continue to be a grand success. The new drug pipeline would remain rich and sustainable. R&D costs would be increasingly more productive, with the rapid and more frequent churning out of blockbuster drugs, in various therapy areas.

However, an affirmative response to this question, if any, has to be necessarily supported by relevant credible data from independent sources.

Additionally, yet another equally critical query would surface. Why then the prices of newer innovative drugs have started going through the roof, with the rapid escalation of R&D expenses?

Thus, there is a need to ponder whether the continued hard effort by many large innovator companies in this direction is yielding the desired results or not.

In this article, I shall try to dwell on this issue with the most recent data available with us.

A new research report:                

A new research report of the Deloitte Center for Health Solutions titled, “Measuring the return from pharmaceutical innovation 2015: Transforming R&D returns in uncertain times” states that the R&D returns of major life sciences industry groups have fallen to their lowest point in 2015, since 2010. The report tracked and reviewed the estimated returns of 12 leading global life sciences companies.

Some of the data presented in this report would give an idea about the magnitude of current challenges in this space. Nevertheless, there could be a few rare and sporadic green shoots, which can also be cited to claim a revival in this area.

I am quoting below some key pharma R&D trends, for the period starting from 2010 to 2015, as illustrated in the Deloitte report:                      

A. Declining R&D productivity: 

Year R&D return (%)
2010 10.1
2011 7.6
2012 7.3
2013 4.8
2014 5.5
2015 4.2

B. Increasing drug development cost with decreasing estimated sales:

During 2010 to 2015 period, the average peak sales estimate per drug has fallen by 50 percent from US$ 816 million to US$416 million per year, while the development costs per drug, during the same period increased by 33 percent, from US$ 1.188 billion to US$ 1.576 billion.

C.  Smaller Companies showing better R&D productivity:

Between 2013-2015, relatively smaller companies showed better R&D productivity as follows:

  • Big companies: 5 percent
  • Mid to large cap companies: 17 percent

D. External innovation becoming increasingly more important:             

Again, mid to large cap companies opting for more external innovation are showing a higher proportion of late stage pipeline value, as below:

  • Big companies: 54 percent
  • Mid to large cap companies: 79 percent
A fear of failure?

The Deloitte report throws some light on the general stakeholders’ concerns about the exorbitantly high price fixation for innovative new drugs by the concerned companies, together with consequential macroeconomic pressures.

One of the key suggestions made in this report, is to increase the focus on reduction of R&D costs, while accelerating the new drug development timelines. I shall broach upon this point briefly just in a short while.

However, the stark reality today, the hard efforts still being made by many large global drug companies to almost replicate the old paradigm of highly productive pharma R&D, though with some tweaking here or there, are not yielding expected results. The return on R&D investments is sharply going south, as the new drug prices rocketing towards north.

Is it happening due to a paralyzing fear of failure, that moving out of the known and the traditional sphere of the new drug discovery models could impact the stock markets adversely, making the concerned CEOs operational environment too hot to bear?

Be that as it may, without venturing into the uncharted frontiers of the new drug discovery models, would it at all be possible to bring out such drugs at a reasonable affordable price to the patients, ever?

I have deliberated before, in this blog, some of the possible eclectic ways in this area, including in one of my very recent articles on January 4, 2016 titled, “2015: Pharma Industry Achieved Some, Could Achieve Some More”.

New innovative drugs evaluated over priced: 

Here, I would not quote the prices of Sovaldi and its ilk, which are known to many. I intend to give examples of just two other new drugs that have triggered significant interest as potential advances for the care of patients in two common disease areas, namely, asthma and diabetes. These two drugs are GlaxoSmithKline’s Nucala® (Mepolizumab) for Asthma and Novo Nordisk’s Tresiba® (Insulin Degludec) for Diabetes.

According a December 21, 2015 report of the ‘Institute for Clinical and Economic Review (ICER)’ of the United States:

“The annual price of mepolizumab would need to be discounted 63-76% to be better aligned with value to patients and the health system, while insulin degludec would need to be discounted less than 10% to do so.”

Thus, there has been a growing mismatch between the value that new innovative drugs, in general, offers to the patients and the price that the innovator companies fix for such drugs. This trend, if continues, would significantly limit patients’ access to new drugs, as the pharma players keep chasing disproportionately high profitability to increase their shareholder value.

External sourcing of R&D may not make new drugs affordable:

Taking a cue from the highly successful strategy of Gilead, especially what it has done with Sovaldi and Harvoni, if other major global pharma players’ also try to enrich their late stage new drug molecule pipeline from external sources, would that effectively resolve the core issue? 

In my view, this could possibly be one of the ways to contain R&D expenses and with much lesser risk, as suggested in the Deloitte report. However, I doubt, whether the same would effectively help bringing down the prices of newer innovative drugs, in tandem.

This is primarily because of the following contemporary example, that we now have with us.

Although the active compound that is used to manufacture Sovaldi, or for that matter even Harvoni, is not Gilead’s in-house discovery, the prices of these drugs have already gone through the roof. 

It is altogether a different matter that robust patent laws along with the Government vigilance on obnoxious drug pricing is gradually increasing in various countries. Some developed and developing markets of the world, including the Unites States and the United Kingdom, either already have or are now mulling for an effective counter check to irresponsible drug pricing, primarily by putting the ‘innovation’ bogey right at the very front.

In India, prompted by its robust patent law and to avoid any possibility of Compulsory Licensing (CL), Gilead ultimately decided to give Voluntary Licenses (CL) for Sovaldi to several Indian drug companies. These pharma players will manufacture the drug in India and market it in the country at a much lesser price.

A new cooperative effort for cancer drugs:

On January 11 2016, ‘The New York Times’ reported the formation of ‘National Immunotherapy Coalition (NIC)’. This is a cooperative effort by some leading global pharma companies to speed up the testing of new types of cancer drugs that harness the body’s immune system to battle tumors. The NIC will try to rapidly test various combinations of such drugs.

This is important, as many researchers believe that combinations of two or more drugs that engage different parts of the immune system might be effective for more patients than a single drug.

On the face of it, this initiative appears to be a step in the right direction and could make the cancer drugs more affordable to patients. However, only future will tell us whether it happens that way or not.

Conclusion:

Nevertheless, the bottom line is, to make the new innovative drugs available at an affordable price to patients, along with strict vigilance by the government bodies, the old and a traditional ball game of drug discovery has to change.

This would necessarily require fresh eyes, inquiring minds and high IQ brains that can bring forth at least significant eclectic changes, if not a disruptive innovation, in the new drug discovery and development process, across the world.

Otherwise, and especially when the low-hanging fruits of drug discovery have already been plucked, if the major global pharma players continue striving to replicate the grand old path of new drug discovery, the efforts could very likely be, and quite akin to, chasing a rainbow.

By: Tapan J. Ray

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

The Curious Conundrum of New Drugs Approval Process

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Fathoming the details of just a short span of time, not going beyond the last 10 years, I find from the published data that many new drugs, such as, Alatrofloxacin, Aprotinin, Drotrecogin alfa, Lumiracoxib, Propoxyphene, Rofecoxib, Rosiglitazone, Sibutramine, Tegaserod, Tetrazepam, were withdrawn from a number of important global markets. Quite a few of those were withdrawn also from the world market.

The key reason for almost all these withdrawals was serious safety concerns for the patients while using these medicines. Interestingly, some of these new molecules were withdrawn even after attaining the blockbuster status, such as Rofecoxib.

Tens of thousands of patients have died only because of this reason, according to reports.

It is widely believed by the experts in this area, if full public disclosure of the entire data of drug clinical trials was made, most of these new drugs would not have seen the light of the day and without putting many patients’ health safety in jeopardy.

All this is a part of a curious conundrum in the new drug approval process, across the world, for various reasons. In this article, I would try to dwell on this issue.

Voices against this ‘unethical practice’ getting louder:                                             

On December 22, 2015, ‘CBC News’ published an interesting article, titled “Researcher issues ‘call to action’ to force release of hidden drug safety data: Bringing drug industry data into the light of public scrutiny.”

The article echoed the same belief of other global experts and, in fact, went a step forward. It categorically reiterated, if full disclosure of the entire data of drug clinical trials is made public, medical practice might have been quite different.

To drive home this point, the article cited the example of the arthritis drug rofecoxib (Vioxx), which has been linked to tens of thousands of deaths related to heart attacks.

It highlighted, although this risk was very much known to the regulatory authority of the United States, the relevant data was not released to the public for an impartial scrutiny.

Quoting different sources, the paper observed, almost half of the drug trials remain secret and the studies that are published, overwhelmingly report results that make the drug in question look good.

Independent experts’ views differed from the innovator companies:

In some cases, when researchers were able to see what is hiding in the filing cabinets of the drug innovator companies, a different picture altogether emerged on the overall profile of those drugs.

One group looked at 12 antidepressants, comparing the published studies with the internal US FDA assessments. They found that 94 per cent of the published studies were positive, as compared to 51 per cent, when they included all of the studies assessed by the drug regulator.

Based on a detailed study, the authors concluded, without considering all the data, drug effectiveness can often be exaggerated, leading doctors and patients to assume that the medications work better than what they actually do. The ongoing practice of the drug players may help them to significantly diminish the risks, related to the benefits offered by these medicines.

A few months ago, another group analyzed the data from an unpublished drug company study about the effect of Paxil on teen depression and found that the drug did not work and was not safe for the patients. This result completely contradicted the original, unpublished study on this drug.

A crusader emerged in Canada:

Interestingly, the same article, as above, states that Mathew Herder , the health law associate professor at Dalhousie University in Halifax, Canada is now taking up the fight. He is now “calling on other doctors, researchers and journalists to bombard Ottawa with their own demands for drug industry data, using the new legislative lever called the ‘Protecting Canadians from Unsafe Drugs Act,’, which was passed late last year in Canada. 

He has also created a template to help doctors, researchers and journalists access drug safety data at Health Canada. Herder reportedly could even include biomedical researchers, doctors who prescribe medicine, investigative journalists pursuing questions about drug safety, and other activists and patient groups.

This example is worth imbibing elsewhere.

The ‘Rule Books’ are in place, though with loopholes:

To curb such alleged patient unfriendly practices of the innovative drug manufacturers, while obtaining the marketing approval of new drugs, various rules and procedure were put in place, by various authorities.

I shall deliberate below a few of these rules, and enough loopholes therein, enabling the interested parties to hoodwink the external experts, at the cost of patients.

International Clinical Trials Registry Platform:

Much before Herder, following a ministerial summit on Health Research in 2004, a World Health Assembly Resolution passed in 2005 called for unambiguous identification of all interventional clinical trials. This resolution led to the establishment of the ‘World Health Organization (WHO) International Clinical Trials Registry Platform’. It collates information on trials that have been notified in a network of clinical trial registries.

According to W.H.O, “The registration of all interventional trials is a scientific, ethical and moral responsibility”.

In the latest version of the Declaration of Helsinki, it reiterates, “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.”

It unambiguously states, “Researchers have a duty to make publicly available the results of their research …. Negative and inconclusive as well as positive results must be published or otherwise made publicly available”.

Understandably, W.H.O statement underscores, “There is an ethical imperative to report the results of all clinical trials, including those of unreported trials conducted in the past.”

It is worth mentioning here that on January 1, 2015, by a new policy on publication of clinical data, ‘European Medicines Agency (EMA)’ also decided to proactively publish all clinical reports submitted as part of marketing-authorization applications for human medicines, by the by pharmaceutical companies.

Big Pharma's serious apprehensions on greater Public transparency:  

Before finalization of the above policy, EMA sought comments on its draft from various state holders. On September 5, 2013, in its remarks on the draft, ‘The European Federation of Pharmaceutical Industries and Associations, EFPIA’ expressed its apprehension about the public health safety oriented proactive move by the EMA as follows:

“We are worried by a move towards greater transparency of clinical trials data that appears to be putting transparency – at whatever cost – ahead of public health interests. Our detailed response to the EMA draft policy speaks to this concern. While EFPIA values other voices and opinion in the conversation surrounding clinical trials data, we believe there are better alternatives than what the EMA is presenting.” 

This is of course understandable. That said, it also gives satisfaction to note that EMA did not wilt under any pressure on this score, whatever the anecdotal might of the external force be. 

Gross non-compliance, endangering patients’ health safety:

Although, the standards and requirements of “Public Disclosure of Clinical Trial Results” have been well specified now, and even in most of the Big Pharma websites one can find disclosure norms of clinical trial data, their overall compliance on the ground, is still grossly inadequate, endangering patients’ health safety.

An article published in the BMJ Open on November 12, 2015 titled, “Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012”, well captured the magnitude of this issue. 

Nevertheless, the study analyzed just a subset of drugs approved in a single year, 2012. The researchers only examined whether clinical trials were registered and reported, not what that data suggested about how the drugs worked.

The paper reported the results as follows:

“In 2012, the US FDA approved 39 novel new medicines, known as NMEs, and 35 novel drugs. Combining these lists, the FDA approved a total of 48 new drug entities, 15 of which were sponsored by 10 large pharmaceutical or biotechnology companies with market capitalizations valued over US$19 billion. A total of 342 trials were conducted to gain regulatory approval of the 15 drugs, 24 of which were excluded from our analysis, leaving 318 trials involving 99 599 participants relevant to our study, a median of 17 trials per drug.”

Based on the findings, the authors concluded asunder:

“Trial disclosures for new drugs remain below legal and ethical standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve compliance with legal and ethical standards and the quality of medical knowledge.”

Simultaneously, The Washington Post in an article of November 12, 2015, titled, “How pharma keeps a trove of drug trials out of public view”, summarized this report by highlighting to the general public that one third of the clinical trial results that US FDA reviewed to approve drugs made by large pharmaceutical companies in 2012, were never publicly reported. 

Unethical practices skewing medical science:

On July 25, 2015, ‘The Economist’ published an article titled, “Spilling the beans’. It highlighted again that the failure to publish the results of all clinical trials is skewing medical science. 

This article also brought to the public attention that half of the clinical trial results are never published over several decades. It broadened the discourse with the observation that this specific unwanted practice, distorts perceptions of the efficacy of not just drugs, but devices and even surgical procedures too, in a well planned and a systematic manner. What is most important to note is, it has seriously compromised with patients’ health interest, across the world. 

It keeps on happening, as there are no firm obligations on the part of drug companies for making public disclosure of all such data, both for and against, though all these data are required to be filed with the regulatory authorities. Hence, the overall assessment of the drugs, weighing all pros and cons, is just not possible for any outside expert agency.

For granting necessary marketing approval, the designated authorities, at least theoretically, ensure that the drugs are reasonably safe, and have, at least, ‘some beneficial effects’. However, the prescribing doctors would continue to remain ignorant of the untold facts, the article states. 

According to ‘The Economist’, although in the United States the relevant laws were modified, way back in 2007, to address this issue, it still remains as a theory, the actual practices in this regard are mostly not so.

Despite vindication no tangible outcome yet:

As I said earlier, this fact got vindicated through extensive research by the ‘BMJ Online’ article and many other contemporary medical publications. 

For example, the evidence released earlier on  April 10,  2014 by the Cochrane Collaboration of London, UK, also shows that a large part of negative data generated from the clinical trials of various drugs were not disclosed to the public. 

Again, like Vioxx, though the US FDA was aware of all such data, for a well known drug Tamiflu, unfortunately the prescribing doctors were not. As a result, the U.S. Centers for Disease Control and Prevention (CDC), which doesn’t have the same access to unpublished data as the regulators, recommended this medicine not being able to evaluate it holistically. 

However, as the findings from the unpublished clinical trials eventually surfaced, CDC expressed serious apprehension on the overall efficacy of Tamiflu, quite contrary to the assessment of the concerned big pharma player.

Hence, despite quite a large number of vindications by the experts, no tangible outcome has been noticed on this pressing issue, just yet.                                                                

Conclusion:

Based on all this discussion, the moot question that springs up: Why do the doctors still prescribe such drugs, even after being aware of the full facts?

In this regard, an article titled, “Big Pharma Plays Hide-The-Ball with Data”, published in the Newsweek on November 13, 2014 raised a very valid question. 

It commented, even if Tamiflu does nothing, and there is just a slight chance of life-threatening side effects, why was it approved by the US FDA, in the first place?

Even more intriguing is: Why do the doctors continue prescribing these, especially after the Cochrane Collaboration took the Tamiflu’s maker, Roche, to task about many of its claims, in April 2014.

Incidentally, the Cochrane Collaboration is widely regarded as one of the most rigorous reviewers of health science data. It takes results of multiple trials, looks for faults and draws conclusions. It doesn’t accept funding from businesses with a stake in its findings.

The answer to this question may perhaps be too obvious to merit any elaborate discussion here. 

Be that as it may, this curious conundrum of ‘New Drug Approval’ with ‘Partial Public Disclosure of Clinical Trial Data’ needs to effectively addressed, without further delay. If not, patients’ health interest would continue to get seriously compromised with the continuation of prevailing laxity in its implementation process by the drug regulators.

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.

3D Printing: An Emerging Game Changer in Pharma Business

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On August 3, 2015, Aprecia Pharmaceuticals in the United States took a game changing step towards a new paradigm of the global pharma business. The Company  announced that for the first time ever, the U.S. Food and Drug Administration (US FDA) approved a ‘Three-Dimensional (3D)’ – printed prescription drug for the oral use of epilepsy patients. Although, 3DP has already been used to manufacture medical devices and prosthetics, in the pharma world, this disruptive innovation was never practiced on the ground, till that magic moment came.

The drug is Spritam® (levetiracetam) used as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.

According to this announcement, Spritam® utilizes Aprecia’s proprietary ZipDose® Technology platform, that uses 3D Printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid.

The 3DP technology:

3DP technology is broadly defined as a process for making a physical object from a three-dimensional digital model, typically by laying down many successive thin layers of a material.

The originator of this game changing development is the renowned academic institution – ‘The Massachusetts Institute of Technology (MIT)’in the United States. 

Later on, the MIT licensed out the patented 3DP technology for its use in many different other fields. Among pharma companies Aprecia Pharmaceuticals obtained the exclusive rights to 3D-printing technology for pharmaceutical purposes in 2007.

A high potential game changer:

In pharma, 3DP could possibly emerge as a game changing and disruptive innovation, sooner than later. It could radically change the traditional and well-established strategic and operational models of pharma business, especially the drug discovery process, manufacturing strategy and even the disease treatment process, paving a faster pathway for the much awaited ‘Personalized Medicines’, in a large scale. 

Lee Cronin, a Professor of Chemistry, Nanoscience and Chemical Complexity at the Glasgow University, says that the 3DP technology could potentially be used to print medicines of many types – cheaply and wherever it is needed. As Professor Cronin says: “What Apple did for music, I’d like to do for the discovery and distribution of prescription drugs.”

3D Printers would also throw open an opportunity of getting any drug tailor made for the individual patient’s needs, such as, exact dosage requirements, size, shape, color and flavor of the pill and also in the most appropriate delivery systems, just as what Aprecia Pharmaceuticals did with Spritam® by using this technology. 

In this article, I shall highlight the game changing impact of 3DP only in the following three areas of pharma business: 

  • The drug discovery process
  • Drug manufacturing strategy
  • Supply Chain effectiveness
A. Impact on drug discovery process:

A December 29, 2015 article titled, “Click chemistry, 3D-printing, and omics: the future of drug development”, published in ‘Oncotarget, Advance Publications 2015’ deliberates on the potential of 3DP in the drug discovery process.

The paper states, Genomics has unambiguously revealed that different types of cancers are just not highly complex, they also differ from patient to patient. Thus, conventional treatment approaches for such diseases fit poorly with genomic reality. It is also very likely that similar type of complexity will eventually be identified in many other life-threatening ailments.

Currently, a large number of patients are taking medications that may not help them, on the contrary could harm some of them. The top ten best-selling drugs in the United States are only effective in between 4 percent and 25 percent of the individuals for whom they are prescribed, the paper observes.

However, developing new drugs and tailoring such therapy to each patient’s complicated problem has still remained a major challenge.

One possible solution to this challenge could be to match patients to existing compounds with the help of an equally complicated modelling technique. Nonetheless, optimization of a complex therapy will eventually require designing compounds for patients using computer modeling and just-in-time production. 3DP shows a very high potential to effectively address this complex issue.

This is primarily because, 3DP is potentially transformative by virtue of its ability to rapidly generate almost limitless numbers of objects that previously required manufacturing facilities. 

It is also now becoming clearer that with 3DP, scientists will be able to print even the biologic materials, such as, tissues, and eventually organs. Thus, in the near future, it is plausible that high-throughput computing may be deployed to design customized drugs, which will reshape medicine, the article highlights.

In his short ‘Ted Talk Video Clip’ (please click on this link), Professor Lee Cronin explains his working on a 3D printer that, instead of objects, is able to print molecules for a new drug. It could throw open an exciting potential of a long-term application of 3DP for printing, our own customized new medicine by using chemical inks.

In a nutshell,  Professor Lee Cronin elucidates in his ‘Ted Talk’, how could the immense potential of 3D printers be leveraged to catalyze the chemical reactions in order to print real drugs, as and when required, according to the requirements of individual patients.

B. Impact on drug manufacturing strategy:

Not just in drug discovery, 3DP would equally be a game changer in pharma manufacturing, the way it is operated today, including the state of the art production facilities.

This could very much happen in tandem with the 3DP drug discovery research, moving towards personalized medicine, and simultaneously making the same 3DP an integral part of the new drug production line.

Moreover, besides the opportunity of getting any drug tailor made for individual patient needs, such as, exact dosage requirements, size, shape, color and flavor of the tablet and also the delivery system, 3DP technology can be most productively used to manufacture high priced low volume and patient-specific orphan drugs for the treatment of critical illnesses.

Even for Active Pharmaceutical Ingredients (API), the power and potential of 3DP technology can be well leveraged. On March 12, 2015 the ‘Howard Hughes Medical Institute (HHMI)’ of the United States announced that HHMI scientists have designed a revolutionary “3D printer” for small molecules that could open the power of customized chemistry to many. 

It further stated, small molecules hold tremendous potential in medicine and technology, but they are difficult to synthesize without proper expertise. The automated “3D printer” designed for small molecules is a way to get around this bottleneck. The new technology has the potential to unlock access to customized molecules in a way that will drive science forward, on many levels. Moreover, the potential for cost-savings with 3DP is huge, improving the drug profitability significantly.

C. Impact on 'supply chain' effectiveness: 

Currently, the traditional pharma ‘Supply Chain models’ are primarily based on the following:

  • Efficiency largely with high volume operation
  • Need to drive the cost as low as possible
  • Relatively higher-number of workers
  • The inventory cost
  • The real estate cost, owned directly or indirectly, for the entire ‘Supply Chain’ cycle

3DP technology would enable manufacturers shifting the ‘just in time production and distribution’ processes very close to consumers. Such well spread out and ‘just in time’ drug manufacturing activities catering to varying requirements, from very small to very high, would help reduce the cost of logistics, substantially.

This disruptive innovation will enable even the hospitals to print the required drugs at their own locations with, authorized 3DP file downloads, eliminating the need to keep huge inventory and also protecting patients from counterfeit medicines in the ‘Supply Chain’.

Thus, the bottom-line is, the drug companies will be able to print drugs with 3DP technology on real time demand at a large number of selected locations. This will significantly bring down the finished product inventory, starting from companies’ warehouses and distributors to retail and hospital shelves, to almost zero, making pharma supply chain significantly lean and highly effective.

Additionally, it will enable the pharma companies to manufacture drugs also in all developing countries, resulting in improved access to medicine, at a much lesser cost.

Conclusion:

I believe, this technology has already reached a critical juncture, where it is no longer a matter of conjecture that 3DP would ‘soon’ become a game changer, especially for the drug discovery process, manufacturing strategy and supply chain effectiveness of the pharma business, across the world, including India. Getting a prime mover advantage is vital. 

However, the question still remains: how soon will this ‘soon’ be? 

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.

2015: Pharma Industry Achieved Some, Could Achieve Some More

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Wish You And All Your Near And Dear Ones Peace, Happiness, Good Health And Prosperity in The Brand New Year 2016 

The year 2015 witnessed several noteworthy developments in the pharma industry, just as many other years before. That said, in my view, a few of these happenings were much more impactful, and probably took place for the first time ever, in the year just gone by.

Obviously, one such major development is the overall serious adverse impact on the image of the pharma industry, in general. 

During 2015, the image of the pharma industry got further tarnished by reports of high-profile alleged drug price manipulations. This avoidable saga culminated with the arrest of a pharma Chief Executive Officer (CEO) in the United States, amid a federal investigation, in December 2015.

However, I am not going to dwell on this issue in this article. Instead, I shall select some key strategic pharma business areas, which contribute to the largest chunk of the total overall cost, incurred by the global pharma industry, every year. These areas, as I see, are:

  • Drug discovery research
  • Sales and Marketing
  • Supply Chain
  • Development of new drug delivery systems
  • Patients care and engagements

I have put all these points in the above order, just for the convenience of my discussion in this article. 

With a few examples, I shall give my perspective on these areas of the global pharma industry, dividing them broadly into the following two sub-categories: 

  • Areas where the industry could have done a lot better
  • Areas where the industry made significant progress
The Pharma industry strategy continues to remain broadly traditional:

Pharma sector is globally considered as an industry, which appears to be more comfortable in maintaining and harnessing its traditional approaches, in almost all its field of activities. Although, some tweaking has certainly been taking place, which are primarily to automate or digitalize the same process, aimed at adding more speed together with virtually real time monitoring of operations.

Let me hasten to add here that, some major and newer types of modern tech based collaborative initiatives with large companies outside the pure pharma space, have also been reported, during the year.

I shall deliberate on both these areas, one after another, hereunder. 

A. Areas where the industry could have done a lot better:

Drug discovery research:

With the increasing impact of patent cliff and low productivity in drug discovery research, coming alongside big ticket generic threats, many pharma players seem to be still tweaking with its traditional blockbuster drug discovery model, in 2015.

Slightly changing from this traditional strategic focus, many of them have now started focusing more on ‘Orphan Drug’ research, though with indication of a life threatening disease with low prevalence, intending to go whole hog for very high pricing of these drugs.

By gradually adding more indications, these innovator companies plan to make the ‘Orphan drug’ molecule a money churning blockbuster drug. As a result, the number of venture capitalists, who invest in the early stages of such drug development, has increased significantly in 2015.

According to reports, over 40 percent of all approved orphan drugs are meant for high risk cancer sub-categories with low prevalence rate. Although these drugs are for lifetime treatment, the medicines are frightfully expensive, costing between US$200,000 and US$300,000 per year, for each patient. 

Intriguingly, still a very few drug companies are externalizing drug discovery research or even considering on a large scale, the use of the ‘Open Source’ drug discovery model, which is currently widely used in the Information Technology (IT) industry, as one of the main platforms to get new products.

Sales and Marketing:

Similarly, in the pharma sales and marketing space, there has been no game changing developments, during the last year.

Although, some initiatives that can at best be termed as tweaking on the traditional pharma methods, were visible, especially in the fields of digital marketing and e-detailing. The good old and much tried traditional tools, such as, Medical Representatives’ (MR) product detailing to individual doctors or a large number of ‘medical seminars’/ ‘continuing medical education’ events, of varying scale and dimensions, arranged for the medical practitioners, still ranked at the very top of this domain. 

Here, again, no signs of a paradigm shift were visible to me during the year, nor do I reckon, any game changer is likely to surface, any time soon.

Supply chain:

The immense importance of ‘Supply Chain’ in the overall pharma business does not appear to have been properly understood by the drug companies up until 2015. This has been well vindicated by various credible studies. I would refer below just two of those: 

The Chief Supply Chain Officer Report of September 2014, highlighted that just 39 percent of pharmaceutical respondents see the ‘Supply Chain’ as an equally important part of business success as R&D or sales and marketing. Whereas, 68 percent of consumer packaged goods’ respondents believe that leveraging the true potential of this domain, is one of the key requirements for business excellence.

This is noteworthy, as even ‘The McKinsey report’ of September 2013 stated that supply chains now account for around 25 percent of pharmaceutical costs. The annual spending on it is so staggering of around US$230 billion that even minor efficiency gains in this area could free up billions of dollars for investments elsewhere.

Instead of following its traditional approaches, if the pharma sector adopts even straightforward advances, well established in other industries, the total costs could fall by US$130 billion, ‘The McKinsey report’ estimates. 

Ideally, pharma ‘Supply Chain’ should be considered not just a means of getting the products at the right place, at the right time and in the right quantities, but also as a means of delivering additional value to the customers. This can be achieved with radical strategic intervention in this space with the application of the state of art technology, which was still broadly lacking in 2015. 

B. Areas where the industry made significant progress: 

In this section, by citing examples on two other important strategic business areas of the pharma industry, where significant progress has been reported during 2015, I would try to drive home my point. These two areas are new drug delivery systems and patient care/engagement.

New drug delivery systems:

On the development of new drug delivery systems, some interesting collaborative arrangements have been reported in 2015. As illustrative examples, I would cite just the following two: 

A. “Smart Inhaler”

I have picked up this important area of a new drug delivery system, out of many, as it fascinates me immensely. Here again, I would illustrate my point with just two examples – out of several others, as hereunder:

1. On December 2, 2015, the British drug major GlaxoSmithKline (GSK) reportedly entered into a technology deal with Wisconsin-based Propeller Health. Under this collaboration, Propeller will create a custom sensor for GSK’s Ellipta inhaler. The Propeller platform combines sensors, software, and care team services to improve patient outcomes by providing more insightful and efficient care. GSK is the second largest pharmaceutical company to partner with Propeller Health, which in December 2013 announced a deal with Boehringer Ingelheim to develop a custom sensor for BI’s Respimat device.

2. In September, 2015, Teva Pharmaceuticals reportedly acquired Cambridge, Massachusetts-based Gecko Health Innovations, a smart inhaler company.

Gecko’s main product is a platform for chronic respiratory disease management that also combines a sensor device that connects to most inhalers, a data analytics platform, an accessible user interface, and behavioral triggers to help asthma and COPD patients manage their condition, more effectively.

B. Sanofi and Medtronic strategic alliance in diabetes to improve patient experience and outcomes

Although not many large scale commercial ‘drug discovery’ initiatives based on the ‘Open Source’ model is still not known to me, in the ‘new drug delivery system’ area, a major global strategic alliance, between Sanofi and Medtronic in the diabetes therapy area, has been reported based on this model. This alliance is aimed at improving patient experience and outcomes for persons with diabetes, around the world. 

As I mentioned, the alliance structured as an ‘Open Innovation’ model, will initially focus on the following key priorities:

  • Development of drug-device combinations
  • Delivery of care management services to improve adherence and simplify insulin treatment
  • Help people with diabetes better manage their condition

Patient engagement and care:

Quite encouragingly, in the ‘patient engagement and care’ area too, some of the global pharma majors have taken notable tech-based strides during 2015. Some of these laudable ventures are as follows:

A. Novo Nordisk and IBM partner to build diabetes care solutions on the Watson Health Cloud

According to a Dec. 10, 2015 ‘Press Release’, Novo Nordisk and IBM Watson Health agreed to work together to create diabetes solutions, built on the Watson Health Cloud.

Under this agreement, by harnessing the potential of the Watson Health Cloud, Novo Nordisk aims to further advance its offerings to people living with diabetes and also their health care professionals.

B. Sanofi collaborates with Google to Improve diabetes health outcomes

Less than a couple of months before the Novo Nordisk – IBM partnership agreement, by a Press Release of August 31 2015, Sanofi and Google announced their collaboration to improve care and outcomes for people with type 1 and type 2 diabetes.

According to the release, this collaboration will explore how to improve diabetes care by developing new tools that bring together many of the previously siloed pieces of diabetes management and enable new kinds of interventions. This includes health indicators such as blood glucose and hemoglobin A1c levels, patient-reported information, medication regimens and sensor devices. 

Is the word “Innovation” also being used as a façade?

This important, though contentious issue, is being raised by many today, globally.

In my view, global pharma even in 2015, continued making the mistake of repeatedly highlighting, with high decibel sound bytes that the stakeholders do not understand the value, importance and necessity of innovation, which in any case is far from the truth. Nevertheless, It kept using, rather more misusing, this important word too often to cover up any action of theirs that faced government, general public or media scrutiny.

Additionally, many pharma players seemingly continued to remain contented with a very narrow definition of the word ‘innovation’, limiting its application mostly in the traditional space of drug discovery. While at the same time, many other smarter and more astute innovators, especially in the IT world, besides Google, IBM and Apple, started stepping into the vast healthcare arena, which otherwise could possibly have become pharma’s expanded market.

A am quoting below the names of just five of these amazing innovators, from the published data, just to give you a feel of this interesting area of ‘innovation’ in the health care arena:

  • Medivation: For finding the value of treatments that others ignored
  • Beijing Genomics Institute: For making DNA sequencing a mass-market
  • Medisafe: For using wireless and cloud technology to improve drug adherence
  • Ginger.IO: For harnessing behavioral data to save lives
  • Setpoint Medical: For creating a built-in pain-relief platform 
Epilogue:

Overall, the year 2015 was a mixed bag for pharma. Many pharma players, I reckon, displayed their self serving intent in a more glaring manner. Several captains of this industry generally talked all right things, which are music to many ears, but mostly acted quite differently, going against the public health interest, as reported by the global media.

Many pharma companies continued trying to woo the media cleverly during the year. Some of them, reportedly, even sponsored trips of a few Indian journalists to their respective overseas headquarters. As I understand, many newspaper readers too, had noticed the small print disclosures in this regard, at the bottom of their stories on those companies, written on the return.  I have no intention to be judgmental on such trips. Nevertheless, the global media, including the Indian media, by and large, reported all such deeds, with as much detail as possible, without slightest hesitation.

Encouragingly, a few global pharma majors, such as, Sanofi, Novo Nordisk, GlaxoSmithKline and AstraZeneca challenged this contusing status quo in 2015. They seem to dare to chart into the much uncharted frontier to squarely face the challenge of the changing demands of the changing world order. Probably not so much by trying to change others, but mostly by changing themselves. 

It appears, at least, the likes of the above global players have started accepting the new expectations of the aspiring customers and their fast transforming mindsets, including, the tougher governments enacting contemporary laws and regulations in many countries. In tandem, the exorbitantly high cost and usually low profile advocacy initiatives of drug companies seem to becoming lesser and lesser productive, as evident by the increasing number of avoidable issues that the pharma industry is now facing. Added to all this, a modern and major force-multiplier, in the form of social media, has now started unleashing its unfathomable power of shaping laws, regulations and even public opinion.

I wish this wind of change gaining more speed in 2016, and in that process, ushers in the long awaited dawn of a new paradigm. A paradigm of justice and equity in health care for all, across the world, and especially to my own country – 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.

Wide Gap Between Health Care Needs, And Delivery: Is The Bridge Still Too Far?

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“Health inequities which abound in India must be corrected through investments in a robust primary health care system,” said Professor K Srinath Reddy, chairman, Public Health Foundation of India (PHFI), not too long ago.

The equity gap between health care needs and delivery for the general population of India continues to widen.

As the next Union Budget of India is coming nearer, the question in this regard that comes at the top of mind is:

Would adequate resources be allocated by the Union Finance Minister to bridge this gap effectively now or the elusive bridge continue to remain too Far?

The growing challenges: 

Up until now, despite making some progress in improving access to health care, India continues to face the growing challenges of:

  • Gross inequalities in this area by socioeconomic status, geography and gender. 
  • High out-of-pocket health expenditure pushes its ever increasing financial burden overwhelming on the private households, that accounts for over three-quarters of health spending in India.
  • Exorbitant out-of-pocket health spending is also responsible for mercilessly driving into poverty more than half of Indian households, or around 39 million Indians, each year.

The paper titled, “Health care and equity in India”, published by ‘The Lancet’ on February 05, 2011, well deliberated on this issue. 

The paper identifies 3 key challenges to equity in health care:

  • In service delivery
  • In financing
  • In financial risk protection

In the article titled, “My Expectations From The Union Budget (2016-17)”, written in this Blog on December 07, 2015, I also suggested that adequate resource deployment be made by the Government now in power, in all these three areas, while presenting the forthcoming Union Budget on February 28, 2016.

The root cause of inequity in healthcare:

I reckon, there are, at least, the following three key reasons that can be attributed to this failure, on the part of various Governments in power, till today:

  • Inability, primarily on the part of the central government, to effectively integrate healthcare with socioeconomic, social hygiene, education, nutrition and sanitation related issues of the nation. 
  • Health being a state subject, not much of coordinated and robust planning has so far been taken place in this area, between the Central and the State Governments, to effectively address the pressing health care related growing inequity across the country, in general.
  • Budgetary allocation and other fiscal measures towards health care, both by the central and most of the state governments, are grossly inadequate. 

As I said before, in another article published by this blog titled, “With Highest Billionaire Wealth Concentration, India Tops Malnutrition Chart in South Asia” on January 26, 2015, it is a well accepted fact that reduction of social inequalities ultimately helps to effectively resolve many important health care issues.

Otherwise, only a much smaller population of the country having adequate access to knowledge, social and monetary power, will continue to have the necessary resources to address their health care needs, appropriately.

UNICEF highlights stark inequalities in India:

According to UNICEF, every year, 1 million children below the age of five years die, due to malnutrition related causes in India. This number is worrisome as it is far higher than the emergency threshold, according to the World Health Organization (WHO) classification of the severity of malnutrition.

Highlighting stark inequality in India, the report says, “The net worth of a household that is among the top 10 per cent can support its consumption for more than 23 years, while the net worth of a household in the bottom 10 percent can support its consumption for less than three months.”

Are so called “patient centric approaches” real?

Patients are also bearing a different kind of brunt altogether, from several other corners, on their health related issues.

Today, most of the important stakeholders of the health care industry, in general, seem to be using various facades of ‘patient centric approaches’, just for petty commercial gains, or for gaining some key strategic commercial advantages.

Such entities could well be pharmaceutical industry, doctors, hospitals, diagnostic centers, politicians or any other stakeholders.

It is unfortunate that most of them, at various different times, either pontificate about following ‘patient centric approaches’ or use the patients cleverly just to achieve their respective commercial or political goals, solely driven by vested interests. While on the ground, growing inequity in health care keeps marching north.

A recent paper of NITI Ayog:

In a discussion paper of July 18, 2015 titled, “Health System in India: Bridging the Gap Between Current Performance and Potential”, The National Institution for Transforming India Aayog (NITI Aayog), the policy think tank of the new Indian Government, has also accepted the following 3 critical realities, currently prevailing in the health care environment of India: 

  • India’s progress in health outcomes has been slower in comparison to other countries with comparable incomes and at similar stages of development. 
  • Impressive gains in per capita income should match with an increase in life expectancy or health status. 
  • Out of pocket expenditure in India is high (70 percent of total health expenditure). This is catastrophic for the poor and pushes an estimated 37 million into poverty every year. 

The NITI Ayog paper also emphasized, although health is a subject allotted to the State List, under the Seventh Schedule of the Indian Constitution, the Central Government is jointly responsible for items in the Concurrent List. 

Conclusion:

Currently, India is the global numero uno in the GDP growth rate. Thus, there cannot probably be any better time for the nation to leapfrog in the health care space, with a quantum increase in public financial commitments, to radically revamp the fragile public health system in the country. 

I repeat, incremental progress in the public health care system is just not enough for the country, extensive application of cutting edge Information Technology (IT) effectively, dovetailing with the creation of modern brick and mortar public health care infrastructure, top class human resource namely, doctors, nurses and related skill development process, on an ongoing basis.                                                                             

The Government should also ensure that the domestic health care industry comes forward to shoulder higher responsibility to enable the country in offering greater equity in health care, in tandem with the Union Ministry of Health and the State Governments.

This path, in my view, would help building a more equitable health system with a strong foundation of public health for more than 1.2 billion Indians. In that process the fast widening gap in equity, between health care needs and availability, could be bridged much sooner, and in a sustainable way.

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.

Nutraceuticals: A Major Regulatory Step That Was Long Overdue

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Currently in India the nutraceutical products segment, with surrogate or off-label therapeutic claims, is growing at a reasonable pace.

Many such products are now being directly promoted to the medical profession, just like any other modern medicines, with therapeutic claims not being supported by robust clinical data that can pass through scientific or regulatory scrutiny.

For such use of nutraceutical products, I raised the following two questions in my article on this Blog titled, “Nutraceuticals with Therapeutic Claims: A Vulnerable Growing Bubble Protected by Faith and Hope of Patients” on August 27, 2012: 

  • What happens when the nutraceutical products fail to live up to the tall claims made by the respective manufacturers on their efficacy and safety profile?
  • Are these substances safe in those conditions, even when not enough scientific data has been generated on their long term toxicity profile?

Importance of robust clinical data for any product with therapeutic claims:

For similar claim of therapeutic efficacy in the treatment of a disease condition, any drug would require establishing its pharmacokinetics and pharmacodynamics with pre-clinical and clinical studies, as stipulated by the drug regulators. Some experts believe that these studies are very important for nutraceutical products as well, especially when therapeutic claims are made on them, directly or indirectly. This also because, these substances are involved in a series of reactions within the body. 

Similarly, to establish any long term toxicity problem with such products, generation of credible clinical data, including those with animal reaction to the products, both short and long term, using test doses several times higher than the recommended ones, is critical. These are not usually followed for nutraceutical products in India, even when therapeutic claims are being made.

Some experts in this field, therefore, quite often say, “A lack of reported toxicity problems with any nutraceutical should not be interpreted as evidence of safety.” 

The current status:

Currently in India, nutraceuticals, herbals and functional foods are covered under the definition of ‘food’ as per Section 22 of Food Safety & Standards Act, 2006. These food products have been categorized as Non-Standardized/special food products. Neither was there any properly framed guidelines related to manufacturing, storage, packaging & labeling, distribution, sales, claims and imports, nor any legal fear of counterfeiting.

A recent reiteration of the need of regulatory guidelines for nutraceuticals:

In a study on ‘Indian Nutraceuticals, Herbals, and Functional Foods Industry: Emerging on Global Map,’ jointly conducted by The Associated Chambers of Commerce and Industry of India (ASSOCHAM) and RNCOS and released by ASSOCHAM on August 17, 2015 the above key apprehensions on the lack of any kind of regulatory guidelines for the approval and monitoring of products falling under this segment, were reiterated.

The market:

According to the above study, the global nutraceuticals market is expected to cross US$ 262.9 billion by 2020 from the current level of US$ 182.6 billion growing at a compound annual growth rate (CAGR) of about 8 percent.

United States (US) has the largest market for the nutraceuticals, followed by Asia-Pacific and European Union. Functional food is the fastest growing segment in the US nutraceuticals market. Germany, France, UK and Italy are the major markets in the European Union for nutraceuticals. Japan (14 percent) is the major consumer of nutraceuticals in Asia-Pacific, followed by China (10 percent).

The Indian nutraceuticals market is at a nascent stage now, but fast emerging. India accounts for around 1.5 percent of the global market. However, the above study forecasts that due to rising awareness of health and fitness and changing lifestyle, India’s Nutraceuticals market is likely to cross US$ 6.1 billion by 2020 from the current level of US$ 2.8 billion, growing at a compound annual growth rate (CAGR) of about 17 percent. 

Phytochemicals in nutraceuticals:

Phytochemicals have been broadly defined as chemical compounds occurring naturally in plants. A large number of phytochemicals, either alone and/or in combination, are currently being used as nutraceuticals with significant impact on the health care system, claiming a number of medical health benefits, including prevention, treatment and even cure of many types of diseases.

The most recent regulatory intervention:

Responding to the growing demand for regulatory intervention in this important matter, on November 30, 2015, by a gazette notification, the Government of India included phytopharmaceutical drugs under a separate definition in the Drugs & Cosmetics (Eighth Amendment) Rules, 2015, effective that date.

This regulatory action also followed the rapidly growing use of these drugs in India, which includes purified and standardized fraction with defined minimum four bio-active or phytochemical compounds. 

On the ground, this significant regulatory measure would necessarily require the pharma players to submit the specified data on the phytopharmaceutical drug, along with the application to conduct clinical trial or import or manufacture in the country.

The salient features of the notification:

I am summarizing below, only the salient features of the detail notification for obtaining regulatory approval of these drugs in India:

A. Data to be submitted by the applicant:

A brief description or summary of the phytopharmaceutical drug giving the botanical name of the plant: 

- Formulation and route of administration, dosages

- Therapeutic class for which it is indicated

- The claims to be made for the phytopharmaceutical product.

- Published literature including information on plant or product or phytopharmaceutical drug, as a traditional medicine or as an ethno medicine and provide reference to books and other documents, regarding composition, process prescribed, dose or method of usage, proportion of the active ingredients in such traditional preparations per dose or per day’s consumption and uses.

- Information on any contraindications, side effects mentioned in traditional medicine or ethno medicine literature or reports on current usage of the formulation.

- Published scientific reports in respect of safety and pharmacological studies relevant for the phytopharmaceutical drug intended to be marketed.

- Information on any contraindications, side effects mentioned or reported in any of the studies, information on side effects and adverse reactions reported during current usage of the phytopharmaceutical in the last three years, wherever applicable.

- Present usage of the phytopharmaceutical drug ,  –  to establish history of usages, provide details of the product, manufacturer, quantum sold, extent of exposure on human population and number of years for which the product is being sold. 

B. Human or clinical pharmacology information

C. Identification, authentication and source of plant used for extraction and fractionation

D. Process for extraction and subsequent fractionation and purification

E. Formulation of phytopharmaceutical drug applied for

F. Manufacturing process of formulation

G. Stability data

H. Safety and pharmacological information

I. Human studies

J. Confirmatory clinical trials

K. Regulatory status in other countries

L. Marketing information, including text of package inserts, labels and cartons

M. Post marketing surveillance (PMS)

N. Any other relevant information that will help in scientific evaluation of the application

Conclusion:

Prior to the above gazette notification, companies marketing nutraceutical products in general and phytochemical products, in particular, used to operate under a very relaxed regulatory framework.

Such products are currently promoted with inadequate disclosure of science based information, particularly with the surrogate therapeutic claims, which are based merely on anecdotal evidence and forms a part of intensive off-label sales and marketing efforts on the part of respective marketing players. It continues to happen, despite the fact that off-label therapeutic claims for any product are illegal in India, just like in many other countries.

Appropriate measures now being taken by the Government on phytochemical drugs, are expected to further plug the regulatory loopholes for off-label therapeutic claims without any robust scientific evidence. This particular regulation would also, hopefully, help curbing marketing malpractices to boost sales turnover of such products.

Considering all this, it appears that this is a major regulatory step taken by the Indian Government that was, in fact, very long overdue. Implemented properly, this would ensure predictable health outcomes and improved safety standards for most of the nutraceutical products, solely keeping patients’ health interest in mind.

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.

Worsening Health Effect Of Climate Change In India: A Perspective

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At present, out of the top five most pressing global and local environmental challenges, ‘Climate Change’ features at the top.

It has been broadly defined as, “a change in global or regional climate patterns, in particular a change apparent from the mid to late 20th century onwards and attributed largely to the increased levels of atmospheric carbon dioxide produced by the use of fossil fuels.” 

The impact of Climate Change’ is so profound that, if not addressed immediately, it would most likely to cause extinction of human life from the planet Earth and that too in the most agonizing and painful way, lasting over a long period of time.

The Paris Summit and its objectives: 

To effectively address the ‘Climate Change’ issue, nearly 150 world leaders of 196 countries, including Prime Minister Modi, deliberated in the Paris summit earlier in December 2015. Their representatives and negotiators ultimately succeeded, at the fag end of the ‘Paris Summit’ to arrive at a global consensus for inking a new ‘Climate Change’ agreement.

Prior to this, a report titled, “Paris 2015: Getting a global agreement on climate change”, published in August, 2014 by the Green Alliance Trust, United Kingdom stated that the agreement, expected to be signed in this Paris summit should ensure a meaningful united global action on climate change, covering the following key points:

  • A strong legal framework and clear rules
  • A central role for equity
  • A long term approach
  • Public finance for adaptation and the low carbon transition
  • A framework for action on deforestation and land use

Experts opined that a strong deal will make a significant difference to the ability of individual countries to tackle climate change by ensuring the following:

  • Give a clear signal to business for desired environmental protection and pollution control
  • Guide investment toward low carbon outcomes
  • Create a simpler, more predictable framework for companies operating in different countries
  • Help meeting international development aims, which are at increasing risk from rising global temperatures.
  • Help reducing poverty
  • Help improving health and building security
  • Fetch huge benefits to the natural environment by helping to avoid biodiversity loss and the degradation of ecosystems upon which the existence of human life depends

India’s position on ‘Climate Change’:

India’s position on ‘Climate Change’ has been clear and is well captured in Prime Minister Modi’s reiteration in the Paris summit as follows:

“Climate change is not of our making. It is the result of global warming that came from an industrial age powered by fossil fuel. Yet, we face its consequences today, and that is why the outcome in Paris is so important and we are here today. We want the world to act with urgency. Agreement must lead us to restore balance between humanity and nature. We want a comprehensive equitable and durable agreement in Paris.”

Worsening health effect:

‘Climate Change’ could even drive the human race to extinction in its final outcome. Meanwhile, besides its devastated environmental impact on the planet Earth, it would gradually but surely worsen human health conditions.

In this article, I shall focus only on human health perspective on ‘Climate Change’. 

Direct and indirect health impact:

I would classify the adverse impact of ‘Climate Change’ on health basically into two categories:

- Indirect

- Direct

Indirect impact: 

Many of the indirect health impact events of ‘Climate Change’ either go unnoticed or are still considered as an ‘Act of God’. Although this issue relates to our ultimate survival, even today in India not many debates are taking place on the subject, mostly in the Television Channels. This amazing medium continues to remain obsessed with competitive high decibel shouting and slanging matches to strengthen the viewers’ appetite, even more, mostly on trivial sensationalism.

Fortunately, global awareness of the disastrous impact of ‘Climate Change’ is increasing, slowly but surely. 

I shall give below just a few examples of indirect health impact of this change:

- Extreme weather events, such as floods, droughts, tsunamis, heat-waves and other disasters would keep increasing the mortality rate. Many experts attribute the cause of the recent deluge in Chennai to ‘Climate Change’, though there are other view points too. 

- Extreme weather conditions have also started causing frequent crop failures, especially in the developing world like India. As a result, many people go hungry and children suffer from malnourishment, mostly in rural areas, precipitating adverse health consequences.

- The impact of all these on mental health is also at times devastating and should in no way be ignored. Frequent incidences of farmers’ suicide in India due to crop failures could possibly be due to their deteriorating mental health, which needs to be studied in detail.

Direct impact:

According to ‘Big Picture’ – a free and impartial educational resource that explores the innovations and implications of cutting-edge science, rising temperatures and pollution levels may act together to directly worsen various health conditions, a few examples are as follows:

- Researches say, air temperature is more likely to affect cardiovascular function, when ozone levels are high, including the heart’s electrical activity and airflow into the lungs.

- A recent review has established that air pollution sets off nearly as many heart attacks as physical exertion, alcohol or coffee. Belgian researchers examined 36 studies conducted in various countries between January 1960 and January 2010 to examine the percentage of heart attacks attributable to the common risk factors and found that air pollution increased a person’s heart attack risk by 5 percent.

- Higher temperatures may also make the body more sensitive to toxins, such as ozone.   

- Studies show allergies are on the rise in developed countries, including the United States, which could partly be rising carbon dioxide levels and warming temperatures. 

- A number of notorious diseases, such as, malaria and cholera, thrive with the increase in temperature and rainfall. To give an example, the mosquitos that carry the malaria parasites grow rapidly in hot and humid conditions. The increasing prevalence of such weather conditions in climate change is likely to spread these diseases in a much wider population.

Is there any upside for ‘Climate Change’? 

Available information also points out towards some possible, but limited benefits for ‘Climate Change’, as follows: 

- Reduced risk of dying of the elderly persons from extreme cold in the winters of the temperate countries.

- Longer summers in those countries are likely to improve agricultural yields of the farmers.

Let me hasten to add, all these upsides, if at all, may not help the developing and poorer nations of the planet Earth, as such climatic conditions are mostly prevalent in the developed nations of the world.

Need for further research:

A report titled, “A Human Health Perspective On Climate Change”, published on April 22, 2010 by ‘Environmental Health Perspectives’ and the ‘National Institute of Environmental Health Sciences’, identified the following major research areas that need to be further explored and understood in the ‘Climate Change’ perspective:

The above outcome of the study is exactly in the expected line, which was “to identify research needs for all aspects of the research-to-decision making pathway that will help us understand and mitigate the health effects of climate change, as well as ensure that we choose the healthiest and most efficient approaches to climate change adaptation.”

How can we all contribute individually?

On this subject, by a release on November 26, 2011, ‘The National Aeronautics and Space Administration (NASA)’ of the United States recommended some very easy to follow steps for all of us.

It said, each individual can help in this matter by using less energy and water. For example, one may consider turning off lights and TVs when one leaves a room. Turn off the water, when brushing teeth.

It suggests, another way to help is by learning about Earth and its climate. The more we know about how Earth’s climate works, the more we shall be able to help solve problems related to climate change and that is also the purpose of this article.

In addition, besides many others, we may consider lesser use of our private cars and more of available public transports. Smokers may consider to quit smoking. We can also help by planting trees, which absorb carbon dioxide from the atmosphere.

India’s high stake:

A December 9, 2015 article published in ‘The New York Times’, titled “For Indians, Smog and Poverty Are Higher Priorities Than Talks in Paris” reiterated as follows:

At the climate talks in Paris, “few countries have so much at stake as India. For the last month, the front pages of major newspapers have been dominated by one environmental crisis after another: City-dwellers are up in arms about hazardous levels of air pollution, which has already damaged the lungs of about half of Delhi’s schoolchildren. And last month brought torrential rains and flooding in the southern city of Chennai, evoking the erratic weather that climate experts warn about.”

India’s consistent stand in various ‘Climate Change’ talks is drawing a fine balance between rapid development of the nation, with commensurate new job creation and health safety & environment. However, the apprehension that is being expressed now by many, whether that is feasible on the ground at all, for holistic measures in the right direction, with the adequate funds flow for the same.

Thus, the key concern of the Indian negotiators was, signing of any global agreement to support a strong climate regime, without requisite funding, could seriously impede India’s economic growth and development agenda. The developing nations, such as India, therefore, expect adequate and committed funding from the developed nations for generation of clean energy to drive inclusive economic prosperity of the respective emerging economies.

Developed nations still not quite on the same page?

The developed nations, even in the final text of the deal, do not seem to be quite on the same page, with firm financial commitments. As a result, a ‘Tug of War’ of objectives, as it were, surfaced in the final negotiation process – mainly between sustained economic development and stringent global measures with fund commitment to contain possible extinction of the human race in the world.

The impact of an effective implementation of the agreement is expected to last almost in perpetuity.

Conclusion:                                                                              

Finally, on the last Saturday, December 12, 2015 a new global deal to address the pressing issue of ‘Climate Change’, was agreed in Paris. Unquestionably, this is a critical step forward for all countries to save the planet Earth.

Intriguingly, the deal still does not provide for a binding commitment towards adequate funding by the developed countries, which is so essential for the developing nations to adopt clean and renewable energy to contain the devastating impact of the ‘Climate Change’.

Although, the agreement does talk about funding of US$ 100 billion a year from 2020 to 2025, this is not the legally binding part of the deal, as many people had expected.

In my view, if there is just one statesman who could be singled out for taking exemplary initiative to make the deal come through, it would be President Barack Obama of the United States. He spoke several times to the heads of the several developing nations, including India, China and Brazil, many times to iron out the differences till the last moment, for this key global issue – indeed a statesman par excellence, at least to me.

Be that as it may, the deal has now been inked, Indian Government also has expressed its satisfaction and happiness with the final text of the agreement. Still, a key question haunts: Would it produce the desired results, as expected? Well, that depends on how effectively and time bound manner the global commitments get translated into reality, with required fund flowing smoothly, to contain environmental disasters, leading to natural calamities and jeopardizing human health-safety.

Let’s all keep our finger crossed, as the saying goes, “The proof of the pudding is in the eating.”

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.

Heath Care: My Expectations From The Union Budget (2016-17)

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India Celebrated its ‘Constitution Day’ on November 26 this year, as the Constitution of the country was adopted by the Constituent Assembly on November 26, 1949, which came into force on January 26,1950. 

On November 27, 2015, while addressing the Lok Sabha, Prime Minister Narendra Modi said, “If Constitution simply becomes a document to be followed by the Government then democracy will suffer, that’s why it needs to reach the roots.”

The Prime Minister also said, “It is important to strengthen rights and it is as important to strengthen duties.”

Looking at this laudable vision of Prime Minister Modi from the health care perspective, one finds that Indian Constitution also guarantees the ‘Right to Life’ to every Indian citizen.

This prompts two important questions:

- Has this specific ‘Constitutional Right’ – ‘‘Right to Life’, been upheld by any Government of our country, as on date, in its letter and spirit?

- Has this specific Constitutional Guarantee ‘reached the roots,” as the Prime Minister expects? 

A search for answers to these questions gets even more complicated, when one finds that health care, which is so fundamental for human ‘life’, besides driving the economic prosperity of any nation, is getting continuously neglected, even when the Prime Minister is reaching out to all, in pursuit of economic prosperity for the nation.

Better late than never:

As the Indian Parliament has taken a fresh vow in the current Winter Session to follow all the Constitutional provisions unhindered, I sincerely hope that the Union Budget 2016-17 would reflect some road map to uphold this important Constitutional Guarantee provided to all the citizens of India. 

If it truly happens, everybody would applaud the Government, in the right spirit of the good old dictum – it is ‘better late than never’.

What has the ‘Right to Life’ got to do with the Union Budget?

Yes, it is indeed a valid question, as what I am saying is a policy matter and is intimately related to ‘The National Health Policy of India”. 

As we know, a new draft of the ‘National Health Policy’ was prepared by the incumbent Government in 2015 for public discourse. However, the same has not been adopted, just yet.

Nevertheless, that’s not the reason why I am raising this issue in my pre-budget (2016-17) expectations. My argument is, any policy has to be supported by adequate financial commitment and that gets reflected in the Union Budget.

Repetition of the Union Finance Minister’s assertion on health care funding even for the next financial year, just what he did while presenting the Union Budget 2015-16, would no longer suffice, especially after the PM’s ‘Constitution Day’ speech.

Last year the FM had said that health care being a state subject, respective State Governments would make required financial allocations to address health related issues of the states.

Trying to substantiate his point the minister said, following the recommendations of the 14th Finance Commission, the Government has raised the States’ share in the net proceeds of union tax revenues from 32 per cent to 42 per cent.

In my view, not much progress in healthcare, pan India, can be expected with this approach of the Union Government. To implement the same robust ‘National Health Policy’ across the country effectively, the Central Government would require to work with the State Governments shoulder to shoulder in this regard and support them with all necessary resources.

Three fundamental pre-requirements:

I reckon, there are three fundamental pre-requirements to translate this specific Constitutional Guarantee into reality:

  • A robust “National Health Policy” should be put in place well before the Union Budget 2016-17, clearly charting a road map for health care in India. Going by the Prime Minister’s reported obsession on the speed of any decision making by his ministers, I hope, the ‘Health Policy’ rollout would commence soon. 
  • Prioritizing from this policy, the Central and the State Governments together should identify specific health projects, based on majority of citizen’s immediate health needs, for joint implementation. 
  • Allocate appropriate financial resources in both the Union and State Budgets for their speedy implementation, fixing accountability and commensurate reward to bring all these initiatives to fruition, ahead of schedule. 

My expectations on health care from the budget:

With the above backdrop, my overall expectations on health care allocations in 2016-17 Union Budget proposals are as follows:

  • Increase total public health expenditure from the current 1.2 percent to at least 2.0 percent of the GDP and then raise it 2.5 percent over a period of next three years.
  • The main source of financing for public health should remain general taxation by levying ‘Health Cess’, quite in line with with ‘Swachh Bharat Cess’ at the rate of 0.5 percent on all taxable services, besides adding a similar tax on non-essential and luxury items.

The key resource allocation would, at least, be in the following five key areas:

A. Infrastructure and capacity building:

- Focused and well-identified investments in building high quality public health infrastructure and well-skilled human resources for rural India on priority.

- Villages, based on population, would be identified by the respective State Governments.

B. Increasing access to quality public health care:

- Free universal access to primary care services to start with, across the country,

- Free drugs, free diagnostics and free emergency care services in all public hospitals of the country and for all. 

- Free emergency response and patient-transport systems across the country, for all.

C. Strengthening the supply chain:

- Quality drug and diagnostics procurement system by the Central Medical Services Society (CMSS) of the Government needs to be modernized, strengthened and made more efficient with real time data, for easy availability of all required drugs and diagnostics in all public hospitals at the right time and in the right quantity.

-  Today, many life saving drugs and diagnostics are highly temperature sensitive. Thus, adequate cold chain facilities are to be created right from transportation to storage in public hospitals for all such products, maintaining their required efficacy and safety standards for patients.

D. Increasing awareness for disease prevention:

- Intensive multi-pronged, multi-channel and door to door campaigns by the para-medics to increase awareness for identified disease prevention.

E. Performance incentive: 

- To achieve the desired level of success and increase the motivation level in a sustainable way, budgetary provisions to be made for a system of well-structured individual and team performance incentive scheme, when the key implementers exceed expectations by achieving the set goals well before schedule.

- Commensurate punitive measures for failure also to be put in place, simultaneously.

I would not broach upon the area of Research and Development (R&D) for drugs and diagnostics here, as that could probably be considered in a holistic way under overall innovation, science and technology budget allocation required for the country, as a whole.

Conclusions:

I sincerely hope and am also reasonably confident that all these would feature in the final version of the new “National Health Policy” of India. Hence, I have not suggested anything radically different from what the Government is currently mulling.

Thus, when my pre-budget (2016-17) expectations on health care, are read in conjunction with exactly what the PM has recently vowed on following the Constitution of India, and the criticality of taking it to the national grassroots level, it appears obligatory for the Finance Minister to ‘walk the line’, as drawn by the PM himself.

The Constitution of India guarantees ‘right to life’ for all, even in sickness.                                                                

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.