Open letter to the German Presidency of the EU, EU Commissioner for Health, Ministers of Health of EU Member States and the Executive Director of the European Medicines Agency:

The undersigned policy-makers, health-care professionals, researchers and citizens would like to express our concern on the issue of COVID-19 vaccines hurried development and often opaque and unaccountable financial support by the EU and its member states. The pandemic has brought such a disruption of our societies and economies that an unprecedented political pressure on the scientific research community has been exerted by governments, the privates sector and global health actors. Public, philanthropic and private donors have provided massive public funding to “get us back to normal” by means of bringing out a new vaccine with record speed. Whilst the pressure and need for speed are understandable, the need for wide scientific scrutiny, high regulatory standards and universal affordable access to new products need to be highlighted as well

We agree that vaccines are needed as soon as possible but they must have the highest possible degree of efficacy and safety profile to protect patients. Therefore, we call for greater responsibility on the part of political leaders and media who should refrain from making unfounded promises about the imminent large-scale deployment of vaccines while the European Medicines Agency and other regulators have not yet evaluated reliable clinical data on their safety and efficacy (such as third-phase clinical trial results). Regulators in Europe should be allowed to do their job properly and the integrity of the regulatory assessment needs to be defended and upheld. We insist that political desires cannot replace scientific reality. These declarations and the advanced purchase of hundreds of millions of vaccine doses by EU member states could be creating unrealistic expectations among the population about a “magical” solution to this public health crisis when the context of both vaccine development and non-technological measures is much more complex.

Given that vaccines are being developed also thanks to the public financial support with taxpayers money from the EU and EU member states, it is specially important that the public interest of scientific rigor, safety and transparency is strongly preserved.

The stakes are also very high in terms of public trust in biomedical innovation and vaccines specifically. The present commercially-led “gold-rush” to deploy a COVID-19 vaccine without sufficient time for normal guarantees of quality, efficacy and safety, could seriously undermine the public confidence in vaccination. By prioritizing swift market access – possibly through a conditional marketing authorization by the EMA with weak follow-up capacity - over the application of the EU´s legally enshrined “precautionary principle”, accountability and responsibility will be weakened. In this sense, we seriously question that the pharmaceutical industry is being granted financial liability exemptions by Governments and the EU in case of possible financial claims for secondary effects or harms caused by the vaccines. These measures could establish a dangerous precedent for other pharmaceutical products.

We also regret the general absence of conditions on affordable access, transparency and open science in the agreements signed by governments. If these potential vaccines are already being purchased with public money, the public has a right to know the details of the contracts, the complete results of the clinical research assessed by independent scientists before authorization and to have strong safeguards of availability, accessibility and affordability of the final products. It is especially unacceptable and undermines public confidence that the European Commission and EU member-state governments have imposed legal restraints on talking publicly about their COVID-19 vaccine deals signed with industry. Without transparency public trust is impossible.

In addition, we would like to express our dismay over the phenomenon of “vaccine nationalism” which is hampering global equitable access and opening the door to vast inequality across countries. In this sense we regret the weak commitment by the EU and its member states to the COVAX initiative and, especially, to the C-TAP Technology Access Pool of the World Health Organization which seeks to pool scientific and financial resources to assure universal, affordable access to vaccines. Moreover, we support the implementation of the equitable access framework to guide the allocation of possible vaccines across and within countries.

We ask the Ministers of Health of EU member states,the EU Commissioner for Health of the European Commission and the European Medicines Agency to take into account these requests:

1. the publication of contracts and other agreements signed between the EU and its member states with pharmaceutical companies for the development, manufacturing, purchase and deployment of vaccines for COVID-19.

2. full transparency of clinical trial results and protocols of potential COVID-19 vaccine research available to be evaluated in real time by independent scientific experts.

3. the application by the European and national medicines agencies of the highest regulatory standards for evaluating the efficacy and safety of proposed new vaccines for COVID-19.

4. the political and financial commitment by the European Commission and EU Member States to the COVAX initiative and other technology pool initiatives beyond the already announced contribution and to a global strategy for global equitable and affordable access.

5. the inclusion of clauses for open licences and public co-ownership of intellectual property rights in all contracts for the allocation of public financial support to companies and other entities for research and development of COVID-19 vaccines

6. a reversal of all public-private agreements concerning exemption from civil responsibility or financial indemnification granted to companies developing and producing COVID-19 vaccines.

7. We call for transparency on how up front payments have been used so far and on whether there are provisions for the return of public funds in case of non-fruition.

Signed:

Joan-Ramon Laporte, Emeritus Professor of Therapeutics and Pharmacology
Universitat Autònoma de Barcelona. Fundació Institut Català de Farmacologia

Nicoletta Dentico, Head of Global Health Programme for Society for International Development(SID)

Margrete Auken, Member of European Parliament, Denmark

Michelle Rivasi, Member of European Parliament, France

Javier Padilla, médico de Familia, Madrid, Spain

Els Torreele, researcher, biologist and public health advocate, Belgium

Juan Erviti, medical researcher and visiting professor, University of British Columbia, Canada

Fernando Lamata, public health expert, Psychiatrist, Madrid, Spain

Jutta Paulus, Member of the European Parliament and Pharmacist, Germany

Rasmus Andresen, Member of the European Parliament, Germany

Petra de Sutter, Member of the European Parliament, Belgium

VAN SPARRENTAK Kim, Member of the European Parliament, Netherlands

METZ Tilly, Member of European Parliament, Luxembourg

Niinstö Ville, Member of European Parliament, Finland

URTASUN Ernest, Member of European Parliament, Spain.

KONEČNÁ Kateřina, Member of European Parliament, Czech Republic

GUERREIRO Francisco, Member of European Parliament, Portugal

ZACHAROPOULOU,Chrysoula, Member of European Parliament, Greece

JERKOVIC Romana, Member of European Parliament, Croatia

ANGEL Marc, Member of European Parliament, Luxembourg

MALDEIKIENE Aušra, Member of European Parliament, Lithuania

CSEH Katalin, Member of European Parliament, Hungary

SATOURI Mounir, Member of European Parliament, France

WIENER Sarah Member of European Parliament, Germany

BOURGEOIS Geert Member of European Parliament, Belgium

SINČIĆ Ivan Vilibor, Member of European Parliament, Croatia

EICKHOUT Bas, Member of European Parliament, Netherlands

PEDICINI Piernicola, Member of European Parliament, Italy

Maryanne Demasi, Medical researcher and scientific journalist, Australia

Peter Gotzsche, medical researcher, biologist and medical doctor, Denmark

David Healy, Psychiatrist, writer, medical researcher, Rxisk, Professor of family medicine, McMaster University, Hamilton, Canada

Roberto Sanchez, médico de familia, Presidente de No Gracias, Salamanca, Spain