EFPIA and Vaccines Europe note the EU Communication on “Urgent Trade Policy Responses to the COVID-19 crisis", submitted today to the World Trade Organization (WTO). Speaking about its publication, EFPIA Director General Nathalie Moll said. “While welcoming the commitment to limit export restrictions and facilitate trade, as well as encourage the expansion of vaccine and treatment production in collaboration with industry, we are deeply concerned about the threat of compulsory licensing as a vehicle to increase access to COVID-19 vaccines. Compulsory licensing will not facilitate greater vaccine equity but could put the hard-won progress in fighting this terrible disease in jeopardy.”

Innovative vaccine manufacturers and biotech companies continue to be at the forefront of the global effort to develop and manufacture COVID-19 vaccines. This massive effort is succeeding. After more than 200 clinical trials and nearly 300 partnerships and collaborations among manufacturers worldwide, production has increased, in just a few months from zero to 2.2 billion COVID-19 vaccine doses by the end of May with an astounding estimate of 11 billion doses by the end of 2021 (Airfinity data here). This will be enough doses to vaccinate the world’s adult population. Nathalie Moll went on to say “In our Five steps to urgently advance COVID-19 vaccine equity we have set out concrete actions that can be taken to increase the availability of COVID vaccines around the world without diverting raw materials and supplies away from well established, effective supply chains to less efficient manufacturing sites where productivity and quality may be an issue. And without making investment into research on variants and future pandemics more difficult.”

The evidence of the last 15 months shows that intellectual property has acted as the much-needed catalyst to develop COVID-19 vaccines, treatments and diagnostics while R&D on newly emerging variants continues. Cooperation between pharmaceutical industry, regulators and policy makers, and among industry players themselves, has been unprecedented. Over 300 voluntary licenses have been concluded on manufacturing, distribution, including technology transfers.

We agree with the Commission that the broad waiver proposed by a number of WTO members is not the right response to the pandemic and that voluntary licences are the most effective instrument to facilitate expansion of production and share the necessary know-how.

There is no evidence that IP has been, or will be, an impediment to R&D and production of COVID-19 treatments and vaccines, nor is there any evidence that IP has hindered partnership and collaboration between companies and institutions around the world.  Therefore, EFPIA and its Member companies also do not believe the use of TRIPS flexibilities can address the concerns raised, as those concerns can only be addressed by removing the real obstacles to distribution, such as trade barriers, movement of raw materials to existing facilities, and sharing of excess doses.

As we have seen during the pandemic, export restrictions can have a negative and immediate impact on globally integrated supply chains that ensure quality, safety, innovation and timely distribution of COVID-19 vaccines, treatments and diagnostics to patients. We therefore welcome the inclusion of commitments on restricting the use of export barriers in the Communication. It is key that WTO members refrain from imposing export restrictions, and that any such measures, insofar as they do exceptionally occur, are limited in time, are transparent and proportionate. Open supply chains enable manufacturers to organise their global supply and distribution networks as efficiently as possible, allowing vaccines and treatments to reach those places where they are needed the most. We also welcome the proposal to eliminate all trade and regulatory barriers to exports and the adoption of policies that facilitate and expedite the cross-border supply of key raw materials, essential manufacturing materials, and vaccines along with the prioritised mobility of a skilled workforce needed for COVID-19 vaccine manufacturing.

EFPIA also supports commitments for expansion of production. The pharmaceutical industry has committed to undertake all efforts possible to maximize COVID-19 vaccine output without compromising safety and quality, including through additional collaborations with partners that can produce significant quantities. We have also committed to work with governments and individual suppliers of raw materials and components to determine how to quickly and safely facilitate scale up needed for COVID-19 vaccine manufacturing.

The pharmaceutical industry looks forward to work with the Commission to ensure vaccine equity as well as to collaborate on making sure long-term pandemic resilience is supported by creating a dynamic and R&D driven EU pharmaceutical market which requires a strong and predictable IP framework.