AFRICA: HOW INTELLECTUAL PROPERTY LAW IS HOLDING BACK COVID-19 THERAPIES

Médecins Sans Frontières’ Campaign for Access to Essential Medicines (MSF Access Campaign) has hosted the first of a three-part webinar series which will examine how Intellectual Property (IP) has blocked access to Covid-19 therapeutics. The forum also explored lessons from Brazil’s Law reform process and delved into the status of the local IP law reform process in South Africa and how the reform can enable better access to medical tools as well as benefiting South Africa’s economic development.

Moderated by award-winning health journalist, Laura López González, the panel discussion drew on examples of Covid-19 medicines, showing why they are inaccessible as a result of IP barriers and how patent-free policies can enable local manufacturing.

Africa remains largely unvaccinated from Covid-19, González said in an opening statement, adding that the continent remains at risk of successive waves of infection without access to the new Covid-19 treatments increasingly being used to save lives in richer countries. “Meanwhile, the United Kingdom and European Union members continue to block efforts to pass a waiver at the World Trade Organisation that would temporarily suspend IP protections on Covid-19 vaccines, medicines and other goods to help the world respond to the pandemic,” González said.

González introduced the panel.

  • Leena Menghaney, the Global IP Advisor at MSF Access Campaign. A lawyer by training, Menghaney has worked extensively to ensure public health provisions were included in India’s 2005 patent amendment and continues to be involved in patent challenges on essential medicines.
  • Felipe de Carvalho is MSF Campaign’s Advocacy Coordinator in Brazil and Latin America. He contributed to a decision by Brazil’s senate to make compulsory licencing of essential health technologies like drugs and vaccines much easier and faster.
  • Candice Sehoma is the MSF Access Campaign Access Campaign Advocacy Coordinator in Johannesburg where she helps lead the fight to fix South Africa’s IP legislation as a member of the Fix the Patent Laws Coalition.
  • Baone Twala, a legal researcher in the health rights team at public interest law centre SECTION27. She also works on SECTION27’s work with the Fix the Patent Laws Campaign. A large part of her work focuses on access to medicine and domestic legal reform.

Menghaney began by giving an introduction to Covid-19 treatments and the IP issues related to them. “I wanted to talk about something that’s been on the table for a very long time and that’s medicines for Covid-19, but that’s somehow been overshadowed by , of course, the activism that’s been needed for vaccines and, indeed, it’s the correct moment, I feel, when we know that Covid-19 is here to stay in our communities , but we will always need treatment and we need to start talking about them at this crucial juncture,” Menghaney said.

Menghaney proceeded by sharing her screen to display a series of slides depicting the challenges IP ownership has on Covid-19 treatments. “As a flashback to anyone who’s been part of the HIV/Aids movement, we all know it’s about competition – the more suppliers you have, the more affordable treatments are,” Menghaney said, saying that this was something that was encountered with antiretrovirals and the licences required to manufacture them before intervention by the Competition Commission of South Africa. Menghaney also said that this could prove as a framework for lessons that could be applied to Covid-19.

Menghaney continued by discussing the three major classes of medicines that people should be examined. The first of these are monoclonal antibodies. “Traditional thinking suggests that monoclonal antibodies are too expensive for developing countries, and traditionally they are reserved for high income nations,” said Menghaney. She cited the use of Tocilizumab, a monoclonal antibody typically used for the treatment of rheumatoid arthritis, which has resulted in improvement in patients with severe Covid-19 pneumonia, according to the New England Journal of Medicine, as an example.

Menghaney then pointed to Janus kinase (JAK) Inhibitors, medication meant for the treatment of rheumatoid arthritis, according to the U.S. National Library of Medicine. According to Menghaney, several JAK Inhibitors are being considered for the treatment of hospitalised Covid-19 patients. The World Health Organisation (WHO) is reviewing them as a class for guideline inclusion. “They have a very low production cost and can be generically produced in large parts of the world, not just in India,” said Menghaney, though this is made difficult by the treatment’s patents which are only set to expire in 2029.

The last type of medication Menghaney spoke about are antivirals. Multiple compounds are currently in the process of being reviewed, like Molnupiravir which was approved by the U.S. Food and Drug Administration (FDA) for mild to moderate Covid-19 cases. “The cost to produce it generically is U.S.$20 compared to U.S.$700 from a firm like Merck,” said Menghaney when speaking on the benefit of the cost ratio. While progress has been made in voluntary licensing for African countries, nations like Brazil and others in Central Asia have been excluded.

González asked Menghaney to clarify what patents and licences are and how they matter with regard to access to medicine. “Patents, in simple terms, allow a patent holder to block someone else from making and selling a medicine, basically giving that person a monopoly. A licence is something granted to competitors allowing them to produce the same medication,” said Menghaney.

González elaborated on Menghaney’s explanation to say that pharmaceutical giant Merck, which has recently produced a pill-based treatment for Covid-19, has granted voluntary licencing to some Indian manufacturers to allow generic production noting, however, that this was an exception and not always the case with countries being forced to seek compulsory licences to get the treatment they need.

González opened the floor to de Carvalho, noting Brazil’s long struggle to get compulsory licencing and asking him to expand on that. De Carvalho said that Brazil’s situation is similar to that of South Africa with both being emerging pharmaceutical markets, the kind that companies seek many patents. “They charge a lot of money that undermine local public health policies and these countries are in a very difficult position to deal with diseases because the technology they need is very expensive,” de Carvalho said.

“One of the options countries have is compulsory licenses. This is useful in emergency situations where you need a fast solution to suspend a monopoly,” said de Carvalho. This allows third parties to explore patented technologies without needing the authorisation of patent owners. “We do not regard it as patent infringement because when a compulsory licence is issued the patent holder still has some rights reserved, they receive royalties when other producers enter the market so there is a balance,” de Carvalho added.

However, this course is underutilised in many countries, according to de Carvalho, largely due to political reasons, along with pressure from pharmaceutical companies.

“We want to make sure the Brazilian public health system can maintain a response to Covid-19. There will be a cut in the budget for vaccine purchase next year of 85% so we need to find ways to make it sustainable. The budget for Brazil is being reduced but companies like Pfizer are raising the prices with each new contract they make with the country so the inequalities are coming over and over again,” said de Carvalho.

González acknowledged how Covid-19 has exacerbated inequalities in Brazil before turning to Sehoma. “Compulsory licencing is not something South Africa has been able to do because of its patent law regime. What are the problems with South Africa’s patent laws, where are we with reforms and why are we seeing this posturing by the country to waive IP protections while not attending to that same situation at home?” González asked.

“We have seen South Africa spearhead the cause for a waiver on the global stage. On the contrary, we do not have our own house in order when it comes to fixing our own patent law to ensure access to lifesaving medicine,” Sehoma said.

While the government is currently in the process of amending the patent act, the process has been “shockingly slow”, according to Sehoma. “In light of how we’ve been speaking about how IP is such a problem – even our president notes how IP is a barrier – there are still questions why we are not moving locally on this.”

Sehoma also acknowledged that South Africa lacks an easy-to-use administrative system to provide compulsory licenses. “I think abuses of patents have restricted and continue to restrict access to medicines for millions of people including those suffering from tuberculosis, cancer and hepatitis, and now the same is happening with Covid-19,” Sehoma concluded.

González asked Sehoma to comment on pharmaceutical companies’ reluctance to adhere to the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver – which allows states to issue licenses to any third parties to produce and market the patented product without the prior approval of the patent rights holder (https://www.healthaffairs.org/do/10.1377/hblog20210712.248782/full/) – over their assertion that Africa has no capacity to produce vaccines.

“We’ve shown how untrue that is through analyses and studies. Doctors Without Borders have noted this as well by showing the capacity we have in South Africa and across the continent to produce vaccines,” said Sehoma, who likened the pharmaceutical companies’ claims to being a myth to derail to getting African vaccine manufacturers to be able to be independent. “To me it’s an issue of independence, it’s an issue of relying on ourselves and being able to meet local needs,” Sehoma said.

González opened the floor to Twala by continuing the examination of major pharmaceutical companies who also claim that a reviewed patent system would be a hindrance to economies. “That’s something we hear all the time,” said Twala. “Underneath that broad, umbrella myth there are others given to support that. I think the key to busting that myth is really understanding context, specifically in terms of developed countries versus developing countries,” Twala said.

Twala went on to say that there are three categories or ways this can be considered – domestically, globally and thematically. “Domestically, some of the myths include the fact that flexible IP systems discourage development, local industry and innovation. What we’ve actually seen from development in western countries as well as Asian nations is that a big driver of their industrial development was flexible IP systems and now that these countries have achieved that development, they’ve effectively kicked the ladder by enforcing these stringent IP systems, so if we look at a country like South Africa, it’s still developing and needs flexible IP systems to drive development versus a country like the U.S.,” said Twala.

Twala added that economic growth through industrialisation would also be achieved through flexible IP systems. “We’d be able participate more fully in the fourth industrial revolution as well as respond to the need for medicines that are unique to Africa which form part of the neglected medicines in terms of the research and development and innovation that big pharmaceuticals make.”

Speaking on the second category, Twala said that with regard to the assertion that flexible IP systems would discourage foreign investment, research by SECTION27 found that South Africa has attracted less foreign direct investment than countries that offer weaker protections of IP and that foreign direct investment in the country between 1994 and 2007. “We saw over 35 manufacturing plants belonging to foreign pharmaceutical companies close in South Africa. What we’ve also seen is that when it comes to developing regions with lower labour and operating costs, pharmaceutical companies consolidate those type of costs which decreases foreign direct investment and the benefits countries get from that.,” said Twala.

Speaking on trade, Twala said that secondary patenting, otherwise known as ‘evergreening’, prevents local manufacturers in South Africa from producing generic products long after they’re available in other countries. “A patent should have something innovative for it to be registered but what pharmaceutical companies do is that as a patent runs out they will then change an ingredient or something that isn’t crucial for its efficacy so South Africa doesn’t really investigate applications for patents, they then get granted extensions or new patents on the same products which help them to monopolise the market,” Twala said.

On the final category, Twala said that health-driven R&D (research and development) should be a key focus instead of profit-driven R&D, which leads to scenarios like evergreening. “About 12% of the disease burden is made up of neglected diseases and 4% of the therapeutics registered in 2011 actually addressed neglected diseases. So we see that we’re really failing to deliver innovation in that response to our need and, particularly in Africa, we need innovation that responds to those neglected diseases and allows us to find solutions to that,” Twala said.

Credit: Allafrica

Leave a Reply

Your email address will not be published. Required fields are marked *