Podcast: Why is a therapeutics waiver extension different to the vaccine waiver?

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Podcast: Why is a therapeutics waiver extension different to the vaccine waiver?

08.12.22

The current discussions at the WTO centre around a possible extension of the TRIPS waiver – approved for COVID-19 vaccines in June 2022 – to therapeutics and diagnostics for the disease. This proposed waiver extension would make it easier for compulsory licencing to be used for production of therapeutics, including the waiving of patent obligations. This would entail a significant expansion from the original, narrower vaccine scope. So what is the ultimate objective of such a waiver extension? What are the potential benefits, as well as the drawbacks?

The TRIPS waiver extension proponents argue that an extension will support the ramp-up of therapeutics production and improve access to such medicines, especially in low-income countries. While the goals of ramping up production and improving access are valid ones, not only is a waiver extension not needed, it is also not the way in which these goals can be meaningfully achieved.

Dr Koen Berden is the Executive Director of International Affairs for EFPIA. He is part of the EFPIA senior Leadership...

First, there is already extensive evidence showing that a waiver is not needed: currently, there is no shortage of therapeutics for all COVID variants, disease severity levels, and patient settings. Further, due to over 138 voluntary licensing agreements, tiered pricing strategies, and partnerships with multilateral organisations, access – especially in low-income countries – for key therapeutics is already well-ensured (see Figure 1, where coverage for both Paxlovid and Molnupiravir are in orange; Molnupiravir only in blue; and Paxlovid only in green).

Figure 1: Coverage of access initiatives for low- and lower middle-income countries

Additionally, of the 11 million doses of remdesivir produced, over 65% have gone to low-and lower middle-income countries. As to production of sufficient therapeutics doses, it is clear there is no problem for which a waiver extension would be needed. In fact, contrary to its stated aims, a TRIPS waiver extension would rather undermine the legal basis for existing voluntary licensing agreements, including those through the Medicines Patent Pool, and thereby likely reduce – not increase – production.

Second, even if there were a problem regarding production and access, a TRIPS waiver extension is not the right solution. By looking at vaccination rates globally, we see that despite an abundance of vaccines for many months now, levels remain at around 25% for low-income countries. Just as production of vaccines was not the bottleneck for vaccination, neither is it a barrier for therapeutics. Meaningful approaches that would actually serve to concretely improve access include: removal of trade and regulatory barriers, strengthening of the health workforce, an increase in public awareness on treatments, and improved logistics processes. The issue is fundamentally in the realm of uptake and distribution, not in the existence of supply, which is more than adequate.

Finally, what would be further effects of adopting such a measure? This is where a TRIPS waiver extension for therapeutics differs in severity of consequence from the vaccine waiver: it would not only be inefficient, but also proactively harmful.

First, a waiver on therapeutics would significantly increase the scope of the waiver, impacting other sectors beyond pharmaceuticals, such as fine chemicals, packaging, machinery, and transport. Second, it could reduce the quality of produced therapeutics, entailing negative effects for patients (especially in low-income countries). Third, there is no clear definition of what constitutes a COVID-19 treatment. Many existing treatments that were researched and developed for other indications are now being repurposed for COVID-19. Simply put, over 434 other indications could be negatively impacted by the waiver extension (see Figure 2).

Figure 2: Number of other indications impacted by a waiver on COVID-19 therapeutics

Fourth, SME biotech companies will be particularly harmfully impacted, as many repurposed drugs have not yet been approved for their originally intended indications. For many of these smaller biotech companies, an approval for COVID-19 would be their first marketed product – with their viability put at risk by the waiver extension. Fifth, it would reduce the predictability of incentives depended on for continued innovation and with it, future pandemic preparedness. Because we do not know – with the exception of Anti-Microbial Resistance (AMR) – what future pandemics will come our way, the only way to be prepared is to protect and nurture a healthy and robust R&D pipeline. Lastly, a waiver extension would reduce the EU’s strategic autonomy, as production of therapeutics will move out of Europe, thereby reducing production, employment, and – especially – EU exports of therapeutics.

In conclusion: a TRIPS waiver extension is not needed as (i) the supply problem it aims to solve in fact does not exist, (ii) it would not serve to increase production even if such a problem existed, and (iii) it will have multiple negative impacts, ranging from harmful effects for overall innovation, the business of SMEs, and the health of patients. In order to meaningfully increase access, it is important to focus on the actual, complex issues that underly global distribution of COVID medicines: the removal of trade and regulatory barriers, the strengthening of health workforces in low- and lower middle-income countries, an increase in public awareness of treatments, and improvement in logistics processes.