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COVID-19 and pharmaceutical security: is this a turning point in the debate on global access to medicine?

At a time when COVID-19 has got every nation – and everyone – talking corona, the debate about access to medicines has jumped to the top of the agenda.

It’s a big shift. And a big opportunity.

Traditionally, despite the senseless suffering and deaths caused by 2 billion people in the world being unable to get essential medicines, lack of access to medicines has been seen as a ‘low- and middle-income country issue’. Indeed, this issue has plagued resource-limited low- and middle-income countries since the HIV crisis in the late 80s and 90s.

The global community is scrambling to find a way to protect against COVID-19, through developing a new vaccine and exploring whether existing medicines can be used to treat those infected with the virus. But for the time being, with no vaccine and no treatment in sight, the lack of access to medicine to prevent or treat COVID-19 is universal, with no distinction on background or wealth.

In our quest for a vaccine and treatment, we must ensure history does not repeat itself. Unless robust mechanisms are put in place now to ensure populations in low- and middle-income countries  – alongside high-income countries – get timely access to future COVID-19 vaccines and treatments, we will exacerbate rampant injustices in healthcare access. With potentially devastating consequences for the world’s poorest communities.

Developing a COVID-19 vaccine: Who’s footing the bill? And who gets access?

Developing any vaccine is a complex, laborious, lengthy and resource-intensive process. That said, when it comes to a COVID-19 vaccine, the global community fortunately may be able to fast-track.

First, information shared by Chinese researchers about the genetic make-up of this iteration of the coronavirus has given researchers around the world the opportunity to get to work quickly.

Second, this family of viruses is not entirely new to us: two different types of coronavirus were responsible for the 2002 severe respiratory syndrome (SARS) outbreak in China and the Middle East respiratory syndrome (MERS) outbreak in Saudia Arabia in 2012. Once those outbreaks had been controlled, early efforts to develop a vaccine for coronavirus vaccine  stalled due to a lack of interest and funding. This has brought into question the suitability of the current pharmaceutical R&D model.

Third, while some researchers have shown reservations on the speed and process with which vaccine development is taking place, our experience with the Ebola vaccine provides a blueprint to accelerate research and development during emergencies.

But beyond the development phase, who will get the anticipated COVID-19 vaccine?  With governments around the world – such as the UK – beginning to put millions on the table for the development of the coronavirus vaccine, many global health stakeholders have raised concerns about the fate of that vaccine once it reaches the market.

It’s imperative that this outpouring of public investment comes with strict conditionalities of universal and equitable access to all. This should include conditions of full transparency around clinical trials data, cost of R&D and price. Any resultant vaccine should be subject to flexible -intellectual property rights through waivers and the use of non-exclusive licensing. In order to expand the global supplier base, developing country vaccine manufacturers should be engaged by streamlining regulatory pathways, by reducing market entry timelines, and through transferring technology and know-how.

Treating COVID-19: Do we have the right medicines?

With a vaccine up to 18 months away, the treatment picture for COVID-19 is equally unclear, despite unfounded statements around ‘cures’ in the public domain . The World Health Organization’s Clinical Trail Registry currently has 522 trials under ‘COVID-19’. However, the WHO highlights that these multiple small trials with various methodologies may not generate a clear and strong evidence base needed to decide which treatment is best. To overcome this, WHO has announced a global Solidarity Trial where it will compare five treatment arms highlighted below in multiple countries to generate the evidence needed.

 

WHO’s Solidarity Trial

 

The four active treatment arms – should any of them materialise as the treatment of choice – raise very different access challenges. The first option, Remdesivir is a new experimental antiviral drug targeting infectious diseases such as Ebola and SARS produced by Gilead. This drug has already been a subject of controversy: the company filed for ‘rare disease’ status with the US regulator (FDA) – which opens up a fast-tracked regulatory process, company tax breaks, FDA fee waivers and an extended period of monopoly right (thereby blocking cheaper generic options from entering the market) – but quickly retracted its application following scrutiny from public health advocates. This move by Gilead has added to fears that companies may look to capitalise on this opportunity and price COVID-19 medicines, vaccines and diagnostics out of reach for much of the world’s population.

At the other end of the spectrum is AbbVie, the company behind the HIV combination Lopinavir/ritonavir (brand name Kaltera). Abbvie has altruistically decided not to enforce global patent rights on any formulations of the drug, which will enable countries to purchase generic version of the drug if it’s found to be effective.

The access dynamic for the ‘Chloroquine or Hydroxychloroquine’ option differs in that this old antimalarial is a generic medicine that is not protected by patents. Speculation over the potential of chloroquine in treating COVID-19 has led many country governments to stockpile and restrict the export of these medicines. At the same time, export controls on the active pharmaceutical ingredients (APIs) needed for the manufacture of several other medicines have led to global shortages of some medicines. It has also highlighted our dangerous reliance on a handful of suppliers in India and China for APIs: the consolidation of API suppliers poses a grave risk to global pharmaceutical supply security.

Given Gilead’s controversial move (since retracted) to file for rare disease status for Remdesvir, it’s no wonder that countries around the world are trying to mitigate against intellectual property barriers impeding access. Some high-income country governments, such as Germany and Canada, are looking to put in place the necessary legal instruments to ensure access during this pandemic. This essentially means having the ability to revoke pharmaceutical patents in the face of public interest. Sound familiar? These are the same instruments that low- and middle-income countries have been coerced into not using despite the dire state of access in many of them.

Let’s make this moment matter

COVID-19 is forcing governments and the public to reflect on the value of equitable access to strong and resilient health systems. A key message from this global pandemic is the global need for health security and universal health coverage.

I hope that – drawing on lessons from previous epidemics such as the HIV crises and Ebola – the penny also finally drops about the importance of achieving pharmaceutical security.  As we face the greatest threat to global health in our generation, we must ensure existing inequities in access to medicines are addressed head-on rather than exacerbated.

We must ensure the poorest people have access to vaccines and treatments. We must put equity – including in pharmaceutical access – at the heart of our COVID-19 response.

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