Affordability is tied to quality

In a freewheeling conversation, Leena Menghaney, Regional Head, MSF Access Campaign explains to Viveka Roychowdhury how the Covid pandemic has shaped access to treatment, the reforms needed in India's drug regulatory process to ensure quality is linked to affordability and cautions that while India's manufacturing might needs to be safeguarded, we have to guard against giving away too much as part of free trade agreements. Excerpts from the conversation….

Has Covid increased or decreased access and equity of healthcare and treatment?

There’s a panel discussion in MSF’s upcoming inaugural Health and Humanity Conference (August 17, New Delhi) on “How COVID has shaped justice and equity for access to treatment”. The focus is on looking at how COVID has shaped justice and equity in access to treatment.

So has COVID improved the status quo on access to treatment or is its impact more negative?

Its both. The positive is that the scientific community worked together to achieve breakthroughs to diagnose, treat and prevent COVID. Within months, we had a test, within a year, we had a vaccine, and within two years, we had started to see some very effective therapeutics. So you can see that if the right resources are available, mainly backed by governments, you can quickly have scientific breakthroughs.

In that sense, MSF has been highlighting how the pace of scientific progress is glacially slow in neglected diseases or populations. TB is a classic example. It took over four decades before new drugs became available for drug-resistant TB. One of the positives of COVID was that it brought collaboration of the scientific community across borders, and governments provided the resources needed to back these scientific advances. Clinical trials were conducted across countries, regulatory pathways were set up, and data was reviewed by national drug regulatory authorities to quickly make tests, vaccines and therapeutics available in the health system.

Yet, in access to these, a lack of global solidarity became evident despite early promises by world leaders. Technology and production capacity are concentrated in high-income countries and in the hands of a few pharmaceutical corporations. Monopolies on reagents affected the ability of local manufacturers in many countries to supply more tests to their health systems. High-income countries (HICs), including the US, UK, Switzerland, and many EU countries, tied up most of the global supply of vaccine doses early on in the epidemic. By the end of 2021, deadly pandemic waves swept across regions. Yet, many healthcare workers and vulnerable people in low and middle-income countries did not receive their first dose of approved vaccines.

So my point is, you could see public and private research institutions and collaboration among the scientific community to provide the breakthroughs that we needed, from the genomic sequence to the test to the vaccines to the drugs.

But in terms of equity, the high-income countries tied up all the supplies at the pandemic’s peak, so nothing changed for low and middle-income countries. So that came out and should shape the negotiations for the pandemic treaty.

What came out, particularly for regional multilateral forums like the African Union, was that it was not sufficient to depend on imports, donations and the leftovers from high-income countries.

African leaders are now committing to policies that recognise that production capabilities are essential for the continent in the future. They now face the challenge of providing their manufacturers with the policy framework and long-term financial support needed to develop technology and survive. These include investments but also the introduction of time-tested policies that have worked in countries like India, Bangladesh, Egypt and Argentina with developed manufacturing capacities, such as limiting intellectual property barriers that have a chilling effect on local production and giving preference to local manufacturers in public procurement.

So that’s a very positive (result) that you see. Other regions know the value of doing something India has done for the last five decades. India has sustained, both in terms of public investments in technology, giving incentives for technology development, developing pharmaceuticals, biotechnology, biologic drugs, tests, and of course, vaccines.

While India was criticised for blocking supplies by some for reserving supplies for itself, at the same time, it was evident that countries like India benefited from local production at the peak of the pandemic. So you can see the impact of that on the political thinking of the African Union and others that we need to invest in technology and manufacturing So that’s one of the positives.

Pre-pandemic policy efforts to encourage API production did not succeed as well as hoped. Post pandemic, the PLI scheme has received a different kind of policy push. So do you see this as another positive?

Yes. I think two very clear things came out of the pandemic. One, was the policies needed for India to bring back API manufacturing. It was there before the pandemic.

But what you also see is the issue of local production becoming important in the area of diagnostics. Shortages in the supply of reagents – the raw materials –going into making (diagnostic kits) tests. It’s something that India has to invest in and develop the capacity to address as there is heavy dependence on corporations for the reagents and the raw materials that go into diagnostics.

Second are the policies on encouraging local production of diagnostics. It took over a decade for the indigenous PCR machines and the PCR kits for DR-TB, which had been being developed but were not being procured despite meeting quality assurance standards from the WHO. Then because of COVID, policymakers in the health ministry recognised the importance, and you saw the very rapid expansion of PCR testing capacity in the health system across the country due to the pandemic.

The uptake (of PCR technology) by the public sector is what is subsidising the diagnostic manufacturers as the government expanded PCR testing capacity during COVID. This is a very big positive.

India because of its manufacturing capacity, but also the kind of support India gave from a regulatory point of view, from ICMR, the Department of Biotechnology, and the regulatory authority led to a lot of these breakthroughs for India on vaccine production, tests, and, of course, the drugs as well, because there is much political will in India to get these things done.

So, the industry also knew that the government of India was very interested in them producing the tests, vaccines, and drugs. So that’s a positive.

What about vaccines? How will COVID impact policies around vaccines?

For the limited supplies of vaccines and medical products made available to LMICs during the pandemic, pre-conditions were imposed on governments and the central global mechanism Accelerator – A (ACT-A) for COVID-19 vaccines, tests and medicines supply.

Among the most egregious clauses inserted by multinational pharmaceutical corporations in purchase agreements for COVID vaccines was to pass on the legal liabilities for severe injuries resulting from these new vaccines (indemnity clauses) to purchasers like governments and non-governmental organisations (NGOs) procuring vaccines and set a worrying precedent for the future. These clauses from Big Pharma undermine rights in case of severe injuries and transparency of pricing and supply terms and will continue to haunt us.

But there are some positive aspects.

There is now a recognition among some policy makers in Inda that adult vaccination is very important, mainly to provide another tool to address the rise of antibiotic resistance. New vaccines, like the pneumonia vaccine typhoid vaccines, are all essential vaccines that could offset the use of antibiotics at the community level.

We need the ICMR and NCDC to take up the importance of vaccines with the MoHFW to address AMR.

And what about the lessons for India?

It’s very clear that the Indian model of producing generics, vaccines and other medical supplies is an important tool and valuable in a pandemic or health emergencies. India was able to meet its own needs, for over a billion people.

There is a significant lesson for India which was among the few middle-income countries self-reliant in developing and producing tests, vaccines, equipment and medicines. India’s manufacturing might was not developed in a policy vacuum.

Underlying its success in meeting the national need for these medical products is the public sector investment and incentives for the development of technology and the absence of intellectual property barriers in its drug registration laws and health safeguards against frivolous monopolies in its patent system that enable its manufacturers to introduce competition that secures supplies and lowers the prices of vaccines and medicines significantly. Trading away this advantage in the current free trade agreements negotiations with the UK, Switzerland, and the European Union can be counter-productive in addressing health emergencies and future pandemics.

And, of course, the most important thing is that in India, whatever manufacturing happens, it’s tied to public procurement. India is one of the biggest markets for its own industry. So, in that sense, it also gives preference to its manufacturers, and that has sustained the Indian generic industry’s survival for decades.

That’s something that the African Union and others need to think about.

We are seeing a whole discourse on quality issues linked to substandard medicines from India in the global supply chain. Do you feel that that is a push back to this manufacturing might?

The important thing is that India does need to look at how they can continue the reforms on quality. There have been a number of reforms on quality, and I’ll give you some of them.

What’s been done on the quality assurance of antiretrovirals, TB drugs or antimalarials is historic, saves millions of lives across the world, and that model of ensuring that medicines produced in India have the same quality across all countries needs to be replicated in other essential medicines.

It’s very, very important to recognise that civil society fought not only for affordable generics in the HIV/AIDS movement, but for quality assurance as well. The Global Fund today buys millions of dollars worth of drugs from India for TB, malaria and HIV. And that model holds immense value for essential drugs.

The kind of quality assurance we need is not just for specific therapeutic areas, but we need to start thinking about what we want to do across the board for essential medicines and what resources India’s regulatory authority needs to ensure quality from its state licensing authorities.

India doesn’t have one FDA, which is the CDSCO. It has more than 20 FDAs, particularly if you look at the states which have manufacturing capacity, with SEZs.

CDSCO regulates medicines, which are newly introduced, whether it’s a new formulation, an FDC, or a new molecule compound. But CDSCO doesn’t regulate the quality of drugs that are older than four years old.

For example, HIV medicines today, which are more than four years old, go to the state FDAs for licensing. Currently, if you are bidding for a ARV tender in India, you don’t need to do the stability or bioequivalence tests. Because the state licensing authorities do not require that test.

So, It’s not just about testing the drug for contamination at the end, when the product is finally ready. Part of drug regulation is also the process of quality assurance at the time of licensing and after licensing. For example, to ensure that if a manufacturer changes the API source, they inform the FDA about it and ensure that the API manufacturer also complies with WHO GMP standards.

So these are some of the reforms that are much needed in India on quality.

If we do not discuss and debate quality seriously and the kind of reforms needed to consolidate quality work, the chances are that there will be an attack on generic competition from India.

It’s precisely for this reason that we need to consolidate the work on quality that India has done, particularly if you look at the areas of HIV and hepatitis and TB and malaria, where Indian manufacturers have been delivering millions of treatments of quality across the world and saving millions of lives.

I think this consolidation is very important at this point of time if we are not to have the kinds of attacks that we’ve seen in the past from Big Pharma – calling Indian generics counterfeits and trying to block legitimate trade in affordable medicines between countries.

API productionClinical TrialsCOVID-19drug-resistant TBHealth and Humanity ConferenceLeena MenghaneyMSFpandemicPLI schemeregulatory pathways
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