COVID-19: Local manufacturing essential if we are to “treat all”

  • ITPC led a virtual roundtable last week (26 May 2020) attended by civil society treatment experts, researchers, and national pharmaceutical manufacturers. 
  • COVID-19 has amplified the existing need to ensure equitable access to life-saving technologies and treatments.
  • The group was unified in its stance, that the world cannot rely on voluntary mechanisms to increase access, which pharmaceutical companies may choose to opt-in to. Instead, compulsory mechanisms are necessary so that technologies and know-how are automatically transferred.
  • Manufacturing and supply must also be diversified, and additional capacity put in place now, so that demand can be met once effective medicines are identified.

The issue

A number of drugs are currently being trialled for the treatment of COVID-19. “If we imagine that one or more of these drugs are proven to be effective to treat coronavirus, how do we make sure that they are affordable, so that we can treat all?” asked Andrew Hill, a lead researcher at the University of Liverpool, UK. 

The University recently released findings that demonstrate that all repurposed drugs currently being used in COVID-19 trials could be produced for around $1 a day, or even less, including profit.

“The problem is some of these drugs are priced up to a thousand times more than the cost of production, sometimes for very old drugs,” says Hill. “Furthermore, most of the time the majority of funding that has gone into research and development costs has not been invested by the pharmaceutical company that owns the patent, research has relied on government or donor money. If a repurposed drug is effective then what? If patent holders can dictate prices, then we are at risk of having a situation where treatment will be affordable in some countries but not others.”

“We need a price that means anyone with coronavirus in any country can access treatment. For that to happen generic suppliers need to upscale production, and we need to be prepared.”

Mia Lahlou Filali, Executive Director of Pharma 5, Morocco, echoed the same concerns with regards to different pricing for different countries: “If we have a bidding war for the same drug, then potentially we would see high income countries purchasing drugs at a very high price and low and middle countries struggling. We need a worldwide agreement which makes treatment affordable for everyone.”

Dr. Mohga Kamal-Yanni, a global health and access to medicines consultant, based in the UK, expressed how inequitable access will result in choices: “We’ve already seen how shortages of COVID-19 tests resulted in a lack of testing of key groups including health workers,” she says. “I’m worried about this, unless treatment is affordable countries will make decisions about who to treat. It’s not just about price but also quantity, unless production is allowed by generic manufacturers there is not capacity to produce treatment for the whole world.”

Dr. Viviana Muñoz-Tellez, Coordinator for the Development, Innovation and Intellectual Property Programme at the South Centre said: “Innovation by itself is going to do very little. Innovation may reach markets, but that is not necessarily the same as people. We need access.”

The solutions

Muñoz-Tellez continued, outlining a way forward beyond the rhetoric: “There is new language about technologies and treatments for COVID-19 being a ‘global public good’, but what does this mean in terms of actions?”

“Removing intellectual property barriers does need to go beyond voluntary initiatives. There are legal tools available in international agreements, such as compulsory licensing, and we’ve seen a number of countries call for automatic compulsory licensing for COVID-19 treatments, but we need to go even further. For example, we need technology transfer and the sharing of know-how to also be mandatory; countries need the option to manufacture; or they need more and better options for procurement if they rely on importing from other countries.”

“With regards to the repurposed drugs being tested,” continues Muñoz-Tellez, “the World Trade Organization (WTO) does not require countries to grant patents for a ‘new use’ of existing medicines. With regards to new medicines or vaccines that may be developed then patents could  be a barrier. Patent examinations must be applied rigorously, which could result in less patents being granted, and when they are, compulsory licenses can be used when conditions are not ideal. This includes the absence of a reasonable price.”

Muñoz-Tellez also refers to Article 73b in the WTO TRIPS Agreement on security exceptions which states: “Nothing in this Agreement shall be construed to prevent a Member from taking any action which it considers necessary for the protection of its essential security interests.”

She argues that this could be useful when we need access to more than patents, when the ‘trade secrets’ or know-how are necessary in order to upscale production of COVID-19 medicines, this clause could be used to broaden the scope.

Muñoz-Tellez is clear that: “We are not working against the patent holder. It does not prevent them selling, but allows others into the competition to upscale production and reduce price. The patent holder can still sell its product, and profitably.”

Gaelle Krikorian, Head of Policy on MSF’s Access Campaign agrees with Muñoz-Tellez on the need for the mandatory sharing of all COVID-19 technologies. She describes what is needed as: “A binding and enforceable mechanism to ensure that technologies, data and know-how are shared transparently on a mandatory basis, and that the right to use (including produce) COVID-19 medical tools are recognised worldwide on a non-exclusive basis for the response to the pandemic.”

“It’s a crisis situation. We need to be bold. More capacity is needed in the global south, on research and development as well as production,”  says, Krikorian. “We know why we need to diversify production, but we also need to know how to.”

“The criteria for strict, enforceable actions when it comes to sharing technologies is not being discussed publicly. We need transparency.”

Sergey Kondratyuk, Make Medicines Affordable campaign manager, highlights how, although the large, originator pharmaceutical companies employ tactics designed to block generic competition, civil society has built a solid track record in challenging unmerited monopolies. “Building on this success, and on our discussion to date, it would be good to know what the ‘blocks’ are from the perspective of local manufacturers, this could help the access strategies that civil society are working on.”

Luiz Marihno, Executive Secretary of Alfob, Brazil, agreed: “We’ve seen how civil society actions in challenging unmerited patents and reforming patent law can have a historic impact. In Brazil, and across the region, these actions have run down the prices of essential medicines. Having the capacity for regional production has also been very successful.”

Othoman Mellouk, ITPC’s intellectual property lead, summarised, saying: “We need a tough, global discussion. It’s not only about COVID-19 but access to medicines in general. The objective is to use all tools available to remove barriers but also to come up with a different model. Automatic, compulsory mechanisms must be used as standard; we need mandatory transfer of all know-how; we need to promote more clinical research in the global south; and to diversify supply.”

The roundtable was the first of a series of events. It also included an update on the ongoing developments in the clinical trials. Discussions and developments from future policy discussions will be shared.