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Pharma’s Dual Challenge – To Save Lives And Livelihood

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“Jaan hai to jahan hai” (If you have life, you have the world). Prime Minister Modi - with a skillful tweak, used the couplet of the 18th century poet - Mir Taqi Mir, while announcing the criticality of 21-day national lockdown from March 24, 2020 due to Covid-19 global pandemic. Many Indians lapped up this concept, considering it as a short haul sacrifice to save lives. Possibly, because the Prime Minister had said at that time, ‘Mahabharata battle won in 18 days, war against Coronavirus will take 21 days.’

As the Covid-19 went on a rampage despite the national lockdown, the Prime Minister, on April 11, 2020, changed it to ‘jaan bhi and jahan bhi’ (life also, the world also). This slogan seems to be more relevant in the emerging scenario.

After over a couple of months stringent national lockdown, the necessity and urgency of restarting active life started assuming a priority status for all concerned. But, the restarting process won’t be a piece of cake either – for anybody. As it would not only involve saving lives, but also – ensuring proper means of livelihood, making the industries gradually return to normal, and thereby revival of the country’s economy.

Dr. Ashish Jha, Director of the Harvard Global Health Institute, has summarized the nature of this challenge concisely, as quoted by the article – ‘Five key questions about India’s rising Covid-19 infections.’ This was published by BBC News on June 15, 2020. Acknowledging that India is in a very difficult situation, Dr. Jha said, “We are still early in the pandemic and we have a good year or so to go before we turn the corner. The question is what is the plan to get India through the next 12 to 16 months?”

Like many other industries, this is an arduous task to accomplish even for the drug industry, and for that matter – by any country. From the pharma industry perspective, I reckon, the commencement of the ‘restarting’ process, would pose a tough and dual challenge for many players – for different reasons. The current expectations require them going much beyond developing and delivering effective drugs and vaccine to win the Covid-19 war, and include the following, as well:

  • The population needs to develop either a vaccine-induced or a herd immunity, for a long-term protection against Covid-19. Pharma companies can facilitate the former one.
  • The entire population should have access to scientific evidence-based Coronavirus drugs and vaccine – at a price that most people can afford, to achieve the goal of vaccine-induced immunity.

In this article, I shall explore the ground issues in this area while confronting this dual challenge by the pharmaceutical industry, in general.

Developing herd immunity not an option for India: 

As it is known to many, even without an effective vaccine, it is possible for the population to develop a herd immunity. However, in this situation, a very large population will need to get infected, with its consequent impact on healthcare infrastructure and people’s lives. But, it will possibly be foolhardy to even think about this option, particularly for any country, such as India.

Dr. Ashish Jha in the above article on the BBC News, has also captured this challenge, aptly. He articulated, ‘India cannot wait for 60% of its people to get infected to achieve herd immunity and stop the virus. ‘That would mean millions of people dead. And that is not an acceptable outcome.’ Moreover, India’s Covid-19 infection curve has not started flattening – there is no consistent and steady decline, just yet. Thus, a vaccine-induced immunity seems to be the only prudent choice for the country.

Other reasons why an early intervention is necessary:

A national lockdown in India was certainly necessary to save lives. However, its prolonged duration of over 3 months, has caused a widespread confusion, anxiety, and fear among the public regarding the disease. Consequently, it has created several unintended social consequences, such as disease related stigma, discrimination, besides triggering several serious health hazards. The World Health Organization (W.H.O) also recognizes this problem.

Instances of stigma and discrimination against medical personnel – doctors and health care workers are common and have already been reported. Similarly, those working in aviation, especially on flights that were sent to bring the Indians back from COVID-19 affected foreign land, also met the same fate. Interestingly, such instances are not uncommon even within various housing societies for high income groups and communities. The stigma associated with COVID-19 is real and here to stay, at least for some time.

Serious health hazards like, panic, depression and anxiety have also gone viral as the nation was observing lockdown. Experts, reportedly, have opined that the fear of contracting viruses, compulsorily going to institutional quarantine centers and rising number of deaths, among others, are big triggers for all. Many believe, various communications – formal and informal – to keep people indoors, have given rise to such unintended consequences involving average Indians.

These developments further reinforce the critical need for an early therapeutic intervention in the disease treatment and prevention areas, such as an effective vaccine, where pharma can deliver what it does the best, and sooner.

Green shoots of overcoming the first challenge are visible:

Although, the world has not reached there, just yet, some green shoots of overcoming the first challenge with scientific-evidence-based drugs and vaccine, are now in sight. Treating Covid-19 effectively with the old warhorse – dexamethasone at a very affordable price, is almost a reality today. W.H.O has also called to ramp up dexamethasone production for Covid-19 patients.

Meanwhile, a few other drugs, such as remdesivir and favipiravir have also received marketing authorization of DCGI for treatment of Coronavirus in India. Similarly, Oxford University and AstraZeneca’s experimental Covid-19 vaccine have, reportedly, entered the final stages of clinical trials. Scientists are now in the final assessment of how well the vaccine works in protecting people from becoming infected by the virus.

A shift in the most vulnerable population poses another tough challenge:

As the need to restart the economy of the country becomes paramount, alongside the urgency of saving lives and livelihood, a shift in the most vulnerable population for Covid-19 infection is clearly visible.

As many would know, Coronavirus pandemic started with the more affluent class of the society who mainly travel abroad for work or studies. However, it is now spreading fast in the lesser privileged social strata, including poor migrant labors and other marginalized population. The spread now spans across from affluent communities, right through densely populated slum areas. The trend keeps going north, as each day passes, as of now.

In such a situation, to contain the disease effectively, Covid-19 drugs and vaccine must be accessible and affordable to all. Making this requirement another tough challenge for the pharma industry – as and when the therapies receive marketing approval of drug regulators.

Recently available drugs are expensive, even in India:

From the recent trend it appears, unlike hydroxychloroquine or dexamethasone, most of these emergency use Covid-19 drugs, such as remdesivir or favipiravir may not be accessible and affordable to a vast majority of the population, as discussed below.

Like remdesivir, favipiravir is also, reportedly, the subject of at least 18 clinical trials involving more than 3,000 patients across India, USA, Canada, Italy, China, France, UK and other countries. Encouragingly, for the Oxford University developed Coronavirus vaccine, Serum Institute is expected to price it at Rs.1,000 per vaccine. Thus, for a family of 4 persons, it would cost around Rs. 4000. Be that as it may, lets have a look at the comparative clinical efficacy of cheaper and relatively expensive repurposed older drugs, against their respective costs.

Comparative efficacy and cost of a cheaper and expensive repurposed drugs: 

While comparing the relative clinical efficacy of cheaper and relatively expensive repurposed drugs – against their respective costs, some interesting facts surface, as follows:

According to the reported results, published by FiercePharma in an article on June 24, 2020, dexamethasone treatment led to a 35 percent reduction in death rate among patients on invasive mechanical ventilation and 20 percent for those receiving oxygen without invasive ventilation. The dose used was, 6 mg of dexamethasone in a single dose per day – either orally or via intravenous injection – for ten days at a stretch. Whereas, the cost of Dexamethasone (0.5mg) in India, for a strip of 30 Tablets, is around Rs.6.00.

Similarly, the same article reported, remdesivir has been found to reduce the death rate among severe patients to 7.7 percent from 13 percent for placebo, a difference that was not statistically significant.Whereas, remdesivir in India, will cost around Rs 5,000-6,000/dose. And its recommended dose for adults and pediatric patients weighing 40 kg and higher, is a single loading dose of 200 mg on Day 1 followed by once daily maintenance doses of 100 mg from day 2 up to 5 to 10 days.

Similarly, favipiravir will be available in India as a 200 mg tablet at a Maximum Retail Price (MRP) of Rs 3,500 for a strip of 34 tablets. Whereas, its recommended dose is 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14, according to its manufacturer.

An interesting fallout of Dexamethasone study:

An interesting fallout of the dexamethasone study on arriving at a fair price for remdesivir for treating Covid-19 patients, is worth noting. The Institute for Clinical and Economic Review (ICER) had earlier highlighted the “cost-effectiveness” benchmark price of remdesivir ranges from $4,580 to $5,080. However, ‘a new scenario analysis assuming the likely incorporation of dexamethasone as standard of care, produces a lower benchmark price range for remdesivir of $2,520 to $2,800.’

Conclusion:

As on June 28, 2020 morning, crossing half a million mark, the recorded Coronavirus cases in the country have reached 529,577 with 16,103 deaths. And the climb continues. In the context of the same disease, a publication of the London School of Economics and Political Science (LSE) had recently articulated: ‘In less than 3 months, COVID-19 has become a global pandemic of proportions we have not experienced this century. This has led to some of the largest economies in the world racing to develop a vaccine to combat the disease. However, in this time of urgency, patent laws may conflict with the equal provision of these future medicines worldwide.’

In sync with this sentiment, apprehensions of profiteering on drugs, tests, or vaccines used for the COVID-19 pandemic are mounting in almost all countries. Governments are now being encouraged to suspend and override patents and take other measures, such as price controls, to ensure availability, reduce prices and save more lives.

According to reports, Canada, Chile, Ecuador and Germany have already taken steps to make it easier to override patents by issuing ‘compulsory licenses’ for COVID-19 medicines, vaccines and other medical tools. Similarly, the government of Israel issued a compulsory license for patents on a medicine they were investigating for use for COVID-19.

From the industry, a strong demand for fiscal stimulus, such as the removal of the Health Cess and Customs Duty, to support patient access to critical medical products, is also gaining momentum, alongside the early release of Government payment to providers.

Thus, while exploring the dual challenge lying ahead for many pharma companies – to save both lives and livelihood – delivering effective drugs and vaccine may probably be an easier task than improving access to those – for all, in a meaningful 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.

Pharmaceutical innovation and Public Health Interest: Ways to achieving the dual objectives

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Healthcare industry in general and the pharmaceutical sector in particular have been experiencing  a plethora of innovations not only to cure and effectively manage ailments to improve the quality of life, but also to help increasing overall disease-free life expectancy of the population with various types of treatment and disease management options. Unfortunately despite all these, over half the global population is still denied of basic healthcare needs and support.

A 2011 official estimate of the current world population reads as 6.93 billion. Out of which over three billion live with a subsistence of less than US$ 2 per day. Another billion population is surviving on even less than US$ 1 per day. According to published reports around 18 million people die from poverty-related causes across the world, every year.

The World Health Organization (WHO) has estimated that over a billion population of the world still suffer from neglected tropical diseases.

On February 3, 2012, quoting a ‘World Bank and PwC report’, ‘The Economic Times’ reported that “70% of Indians spend all their income on healthcare and buying drugs.”

In a situation like this, challenges that the governments and the civil society are facing in many developing and to some extent even in some developed countries (although for different reasons), are multi-factoral. It has been well established that the humongous global healthcare challenges are mostly of economic origin.

In such a scenario, ongoing heated debate on innovation, Intellectual Property Rights (IPR) and public health interest keeps gaining momentum all over the globe and has still remained unabated.

Argumentative Indians have also got caught in this raging debate. I reckon rightly so, as India is not only the largest democracy of the world contributing 16.7% of the global population, it is also afflicted with 21% of the global burden of disease. Thus, the reason for similar heated debate in our country is indeed no brainer to any one.

Thorny issues:

One of the thorny issues in this debate is the belief that huge R&D budgets of the global pharmaceutical companies are worked out without any consideration of relative value of such investments to the vast majority of population in our society, across the world. These thought leaders argue, as the poor cannot pay for the expensive innovative drugs, they are mostly denied of the fruits of pharmaceutical innovation in their battle against diseases.

These experts also say that safeguards built into the patent system in form of compulsory licenses are not usually broad enough to improve access to innovative medicines to a larger section of the society, whenever required.

In addition, they point out that wide scope of patent grants in areas of early fundamental research, quite often is strategically leveraged by the patentee to block further R&D in related areas without significant commercial considerations to them. Such a situation comes in the way of affordable innovative drug development for public health interest, when need arises.

Inadequate access to medicines in India:

The key issue in the country is even more complicated. Inadequate or lack of access to modern medicines reportedly impacts around 50% of our population. It is intriguing to fathom, why has the nation not been able to effectively address the challenge of access to relatively affordable high quality generic medicines to the deprived population of the society over a period of so many decades?

Thus IPR in no way be considered as the reason for poor access, at least, to generic medicines, especially in India. Neither, it is the reason for inadequate availability of affordable essential medicines for the diseases of the poor.

The key reason, as is widely believed, is inadequate focus on the deprived population to address their public health concerns by the government.

Pharmaceutical innovation and the burden of disease:

A study  titled, ‘Pharmaceutical innovation and the burden of disease in developing and developed countries’ of Columbia University and National Bureau of Economic Research, to ascertain the relationship across diseases between pharmaceutical innovation and the burden of disease both in the developed and developing countries, reported that pharmaceutical innovation is positively related to the burden of disease in the developed countries but not so in the developing countries.

The most plausible explanation for the lack of a relationship between the burden of disease in the developing countries and pharmaceutical innovation, as pointed out by the study, is weak incentives for firms to develop medicines for the diseases of the poor.

A healthy debate:

Many experts argue that greater focus on the development of new drugs for the diseases of the poor, should not be considered as the best way to address and eradicate such diseases in the developing countries. On the contrary, strengthening basic healthcare infrastructure along with education and the means of transportation from one place to the other could improve general health of the population of the developing world quite dramatically.

However, another school of experts think very differently. In their opinion, health infrastructure projects are certainly very essential elements of achieving longer-term health objectives of these countries, but in the near term, millions of unnecessary deaths in the developing countries can be effectively prevented by offering more innovative drugs at affordable prices to this section of the society.

Creation of IGWG by WHO:

Responding to the need of encouraging pharmaceutical innovation without losing focus on public health interest, in 2006 the ‘World Health Organization (WHO)‘ created the ‘Inter-governmental Working Group on Public Health, Innovation and Intellectual Property (IGWG)‘. The primary focus of IGWG is on promoting sustainable, needs-driven pharmaceutical R&D for the diseases that disproportionately affect developing countries.

‘Reward Fund’ for innovation and access – an idea:

A paper  titled, “Optional reward for new drug for developing countries” published by the Department of Economics, University of Calgary, Institute of Health Economics, proposed an optional reward fund for pharmaceutical innovation aimed at the developing world to the pharmaceutical companies, which would develop new drugs while ensuring their adequate access to the poor. The paper suggests that innovations with very high market value will use the existing patent system, as usual. However, the medicines with high therapeutic value but low market potential would be encouraged to opt for the optional reward system.

It was proposed that the optional reward fund should be created by the governments of the developed countries and charitable institutions to ensure a novel way for access to innovative medicines by the poor.

The positive effects of the debate:

One positive effect of this global debate is that some global pharmaceutical companies like Novartis, GSK and AstraZeneca have initiated their R&D activities for the neglected tropical diseases of the world like, Malaria and Tuberculosis.

Many charitable organizations like Bill & Melinda Gates Foundation and Clinton Foundation are allocating huge amount of funds for this purpose.

On January 30, 2012, on behalf of the research-based pharmaceutical industry, Geneva based International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) by a Press Release  announced donations of 14 billion treatments in this decade to support elimination or control of nine key Neglected Tropical Diseases (NTDs).

Without creating much adverse impact on pharmaceutical innovation ecosystem of the country, the Government of India is also gradually increasing its resource allocation to address the issue of public health, which is still less than adequate as of now.

All these newer developments and initiatives are definitely ushering in an era of positive change for a grand co-existence of pharmaceutical innovation and public health interest of the country, slow and gradual though, but surely a change for the better.

Innovation helps to improve public health:

In India, various stakeholders of the pharmaceutical industry feel that there is a need to communicate more on how innovation and IPR help rather than hinder public health. Some initiatives have already been taken in this direction with the pioneering ‘patent pool’ initiative of GlaxoSmithKline (GSK) in Europe and ‘Open Source Drug Discovery (OSDD)’ by the Council of Scientific and Industrial Research (CSIR) of the Government of India.

The pace needs to be accelerated:

The pace of achieving the dual objectives of fostering pharmaceutical innovation without losing focus on public health has to be accelerated, though progress is being slowly made in these areas through various initiatives. Additional efforts are warranted for sustainability of these initiatives, which have not yet gained the status of robust and sustainable work models.

However in India, the government in power should shoulder the key responsibility garnering all resources to develop and implement ‘Universal Health Coverage’ through appropriate innovative healthcare reform measures. Such steps will help achieving the country its national goal of providing affordable healthcare to all.

At the same time, creation of a variant of ‘reward fund’ to encourage smaller pharmaceutical players of India to pursue pharmaceutical innovation needs to be considered expeditiously. This will help encouraging pharmaceutical innovation in a big way within the country.

Address the basic issue of poverty:

It is a well-accepted fact that the price is one of the key determinants to improve access to modern medicines to a vast majority of the population. However, the moot question remains how does one make medicines more affordable by not addressing effectively the basic issue of general poverty in the country? Without appropriately resolving this issue, affordability of medicines will continue remain a vexing problem and a critical issue to address public health in India.

Conclusion:

Innovation, as is widely acknowledged, is the wheel of progress of any nation. This wheel should move on… on and on with the fuel of IPR, which is an economic necessity of the innovator to make the innovation sustainable.

In the book titled, ‘Pharmaceutical Innovation: Revolutionizing Human Health‘ the authors have illustrated how science has provided an astonishing array of medicines to effectively cope with human ailments over the last 150 years.

Moreover, pharmaceutical innovation is a very expensive process and grant of patents to the innovators is an incentive of the government to them for making necessary investments towards R&D projects to meet unmet needs of the patients. The system of patent grants also contributes to society significantly by making freely available patented information to other scientists to improve upon the existing innovation through non-infringing means.

Altruism, especially in the arena of public health, may be demanded by many for various considerations. Unfortunately, that is not how the economic model of pharmaceutical innovation and IPR works globally. Accepting this global reality, the civil society should deliberate on how innovation and IPR can best be used, in a sustainable manner for public health interest, especially for the marginalized section of the society.

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.