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Renewing commitment towards life sciences

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The life sciences industry needs to relook and redraw its strategies to truly fulfil its core duty of ensuring the wellbeing of the masses along with balancing its commercial interests while governments, regulators and policymakers should support and incentivise the industry in a better way to play its role more effectively in public health

“Economic growth and human welfare need to go hand in hand and there is a need to ensure equitable, affordable and timely access to health products and technologies for all,” said Taranjit Singh Sandhu, India’s Ambassador to the US in a recent virtual interaction with Richard Verma, former US Ambassador to India.

“The global health crisis has brought in its wake an economic crisis of a scale that has not been seen in a long time. Grappling with these twin crises, governments today face an impossible choice between public health and economy. We will need a delicate balancing act. We need to revitalise our economies as well as enhance resilience, scalability and sustainability of our healthcare systems,” he added.

His words echo what many experts, leaders and veterans have been pointing out for quite some time, even before the pandemic hit the world. But, the pandemic and its consequences have lent heft to their voices and views.

But, this balancing act demands a renewed commitment from both, public and private stakeholders of healthcare.

As Dr Henk Bekedam, WHO Country Representative to India admits, “COVID-19 has highlighted the need for a broad global coalition of experts from medical, scientific and regulatory backgrounds from both public and private sectors to join forces in finding diagnostics, therapeutics and vaccines against this common global threat.”

So what should it entail? A few experts share their views and opinions.

Drugmakers’ duty

The pharma industry needs to be more agile, vigilant and public health-oriented to play its role in preventing and containing pandemics, today and in future. And, some of the measures that it needs to take on war footing includes:

Ramp up capacities for vaccine production: Dr Bekedam accentuates, “We have always known that it would likely be a virus that would be the next pandemic. One of the ways of ending the pandemic is the development of the vaccine. It was already clear drug makers needed to have increased capacity in producing vaccines. This was also demonstrated during the H1NI when having an effective vaccine helped to protect women who were pregnant and other vulnerable groups. Even though we found the vaccine quickly it took time to scale-up the production in such a way that everyone has quick access to it.”

Boost investments in infectious diseases drugs: Dr Jayasree K Iyer, Executive Director, Access to Medicine Foundation, points out that key learning for drug makers from the coronavirus pandemic is to “not to be complacent, and ensure agility to ensure that supply processes for regular drugs and vaccines are sustained and ‘pandemic proof’.”

She opines, “Many companies have left the infectious disease space in the past years, leaving very few who are today able to develop treatments and vaccines against this highly infectious virus. That cannot be allowed or sustained anymore. There are also very few biotech firms that are truly able to commercialise their drugs or find enough support to do so, while almost all the innovation in any field is coming from biotechs. The world is relying on some few big companies to develop, commercialise and help to stop pandemics. Drugmakers should seriously consider making a comeback to infectious diseases in a big way, and find supportive partners to do so. You cannot sell your oncology treatments if the society is plagued by infectious agents and hospitals are not considered “safe’!”

Make R&D more open: Jaykumar Menon, International Chair and Co-Founder, Open Source Pharma Foundation speaks out, “If one receives public funds, the very least one can do is make the research open, and the products affordable. The industry should also finally open up all of their shelved and failed candidates for the world to examine, and take forward on major public health issues, especially the neglected diseases, for which there are limited markets anyway. The industry should also allow its brilliant scientists to work pro bono on public health matters, and even require 40 hours a year of pro bono work, as many law firms do.”

Rework business models: Many public health experts feel that the pharma sector needs to operate and rework its business models in a more responsible manner. Some even point out that this is important for the sector to grow and profit as well. And, the case of Gilead Sciences and its drug, Remdesivir is often cited.

Dr Bekedam points out, “One of the encouraging lessons we are seeing now is for Remdesivir. This antiviral was initially developed as investigational therapeutics to treat patients with Ebola. It did not demonstrate efficacy against Ebola but has shown in clinical trials for hospitalised COVID-19 patients to recover faster. Based on these promising results, the US and Japan regulatory authorities allowed emergency use of Remdesivir for treatment of COVID-19. This lesson will encourage drug developers to invest more in the development of therapeutics against new diseases.”

Prashant Khadayate, Practice Head of Healthcare at GlobalData explains the case, “Gilead Sciences focussed on infectious diseases and grew to become a major global pharma. According to GlobalData’s Pharma Intelligence Center, Gilead Sciences generated annual sales of $195 million in the year 2000 and reached annual sales of approx. $ 22.4 billion in 2019 at a CAGR of 30.1 per cent. Additionally, the company maintained a net profit margin of 33.2 per cent for the period: 2015 – 2019. Gilead Sciences completely transformed the overall treatment landscape within HCV and HIV with its innovative drugs. Also, they were active with Remdesivir for Ebola which failed in Phase III clinical trials. However, Remdesivir is now being considered as one of the most promising drugs in the treatment of COVID-19 treatment and is currently undergoing clinical trials.”

Thus, the general consensus among most health experts and advocates across the globe is that the life sciences sector should take its responsibilities more seriously and take more measures including continuous investments, a renewed focus on R&D in vaccines and medicines to cure infectious diseases and adopting new approaches to drug development among others, to ensure that the world is better prepared for any future pandemics.

Here are a few happenings across the globe that clearly evidence this:

  • Last month, global investors in 15 major pharma companies urged them “to set aside rivalries and short-term interests and cooperate on finding solutions to the coronavirus.” The investor group includes Nordea, Nomura, Boston Common Asset Management, Pension fund PGGM, and Achmea Investment Management among others. Reportedly, they hold more than 1.9 trillion euros ($2.1 trillion) in assets. (Read: Institutional investors tell Big Pharma to cooperate on coronavirus)
  • In a more recent development, over 140 world leaders and figures signed an open letter requesting governments to come together behind a “people’s vaccine” against COVID-19. The petition, initiated by UNAIDS, demands that “all vaccines, treatments and tests be patent-free, mass-produced and distributed fairly” to fight the coronavirus pandemic. (Read: World leaders unite for people’s vaccine against COVID-19)

Thus, this global health crisis might be instrumental in ensuring that the pharma sector is held more accountable in its role of safeguarding public health.

But, it is important to look at both sides of a story as well. And a couple of financial and economic experts explain the story from the industry’s perspective.

Regulators’ responsibility

They explain that while it is a given that the life sciences industry needs to relook and redraw its strategies to balance its commercial interests while fulfilling its core duty of ensuring the health and wellbeing of the masses, it is equally crucial that governments, regulators and policymakers support and incentivise the industry to play its role more effectively in public health.

Especially so since the pharma sector also plays a crucial role in boosting a country’s economic growth. For example; the past few weeks have not only highlighted India Pharma Inc’s potential and significance in battling this pandemic globally but also in reviving the country’s economy.

So, it is important for governments and funders to incentivise R&D in this sphere because it is common knowledge that drug development is very time consuming, extremely costly and high risk.

As Khadayate explains, “It is difficult to predict which pathogen will spur the next epidemic or pandemic. No one can predict where it will originate and at what level it will impact in terms of infection. Also, research and development require substantial investment and considered to be risky with high failure rates. Without any clarity, companies will not be interested in executing research for the threat, which is difficult to define in terms of the scale or the potential that companies can target. It is good to be proactive, but there has to be some business case to continue research.”

He elaborates, “Pharma companies are unlikely to invest in R&D of a product unless it promises a substantial return on investment. Without obvious financial incentive, they have little to gain by investing in emerging diseases, as potential markets for them are quite unclear.”

To prove his opinion, he gives the example of a targeted pathogen, the Dengue virus with Asia presenting the majority of the disease burden. He points out, “Sanofi spent quite a lot of time and money developing a vaccine (Dengvaxia) for, and it turned out to be a disaster, across all metrics. A lot of companies would point to this as another reason not to invest in this space.”

He continues, “Hence, it is equally important to provide companies with the incentives or the benefit which will at least make their investment sustainable or promote their interests from the future perspective.”

Stating that Gilead Sciences’ experience is only directional and can’t be termed intensive, he also pointed out that there are very rare examples where a pharma company has succeeded with a major focus on infectious diseases (excluding vaccines).

Rohitashwa Prasad, Partner, J Sagar Associates also expresses similar views and says, “With respect of COVID-19, there is a scramble amongst drug companies to develop a vaccine because the US government has set aside public funds and relaxed the liability regime for drug companies. This only illustrates the significance of financial and risk-based incentives in the industry.”

Building a more cohesive ecosystem

Well, both sides offer weighty arguments but what the coronavirus pandemic has clearly underscored is the need for a more unified, interconnected environment in the life sciences sector which supports the wellbeing of all stakeholders. Luckily, we are already seeing greater cooperation between the public and private sectors.

Dr Bekedam cites a few key instances of global co-operation to combat the coronavirus pandemic:

  • WHO’s Research and Development Blueprint has been activated to accelerate diagnostics, vaccines and therapeutics for this novel coronavirus. The Blueprint has facilitated a coordinated and fast-tracked response to COVID-19, including an unprecedented programme to develop a vaccine, research into potential pharma treatments and strengthened channels for information sharing between countries.
  • Another example is how through targeted coordination and funding support such as CEPI for vaccines and the WHO Solidarity Trial for therapeutics, sharing of information, supply-chain management, distribution and scale-up of vaccines is being fast-tracked and optimised. India is also participating in the Solidarity Trial with over 60 countries worldwide.

Similarly, at a workshop on observational studies of real-world data generated during clinical practice in the context of COVID-19, co-organised by the European Medicines Agency (EMA) and Health Canada under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators agreed to step up their cooperation in the following three areas:

  • Pregnancy research to examine the impact of both coronavirus disease and medication use on pregnant women infected with SARS-CoV-2 and on their unborn babies in order to support COVID-19 medicine development, risk management, and planning for safety monitoring of vaccines and therapeutics;
  • Building international clinical cohorts of COVID-19 patients to share expertise and increase study power and data quality in order to meet regulatory requirements and address existing knowledge gaps; and
  • Prepare strong infrastructure for monitoring the safety and effectiveness of vaccines against COVID-19 in order to rapidly detect and minimise risks to patients. (Check: Global regulators commit to cooperate on observational research during COVID-19 pandemic)

Likewise, at the recently concluded WHO Assembly, a consistent message was that global unity is the most powerful tool to combat the coronavirus outbreak.

Hopefully, this growing understanding and intent will get transformed into more actionable and scalable measures to protect the world from the pandemics of the future.

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