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  Promoting transparent and needs-driven EU R&038;D policies

ACCESS DENIED: What happens when Big Pharma is in the driver’s seat

Together with STOPAIDS, Global Health Advocates commissioned a report series, exploring how a lack of transparency in the pharmaceutical industry and the European Union has harmed public health outcomes. Through legal and investigative research, the reports outlines the circumstances in which COVID-19 vaccine negotiations took place and explores the level of influence Big Pharma had in EU decision-making. Together, the learnings from these reports have informed a series of recommendations that decision-makers can implement to increase transparency and protect both public health and democratic spaces.

WHY GET INVOLVED?

The pandemic was a crucial test for EU decision-makers to fulfill their public health responsibilities, to steer their national responses to deliver a swift journey out of the pandemic, whilst also working to ensure a concerted global effort to deliver an equitable response. However, when it came to this journey, industry was not just in the vehicle but may have been actually behind the wheel, and the route to ending the pandemic grew longer as pit-stops for commercial interests were made. The extent to which industry was steering EU decision making was hidden from public view. 

The EU signed agreements cloaked in secret and resisted efforts to disclose any information. Protecting commercial interests came at the expense of transparency around pricing, delivery schedules, dose transfer requirements, and intellectual property commitments that could have helped increase global access to vaccines. With an unaccountable driver, the public have been taken for a ride.

THE OPPORTUNITY

The pandemic further exposed the power imbalance between the pharmaceutical industry, governments, and the public. Health technologies are an essential tool for our society’s health and survival, yet important decisions around their research, manufacturing, and pricing happen behind closed doors. 

It is essential that lessons are learned from the COVID-19 pandemic to protect global health now, and in future pandemics. Ensuring access, transparency, and accountability are fundamental to bettering the EC’s pandemic response.

The European Public Prosecutor’s Office (EPPO) confirmed in October of 2022 that it has opened an investigation into the acquisition of COVID-19 vaccines in the EU, in part motivated by the “extremely high public interest” generated by the affair.  Although the EPPO hasn’t disclosed exactly who is under investigation and why, the office possesses several legal powers that the Ombudsman and the ECA lack.  In addition, the EP’s COVI Committee is preparing its report on the lessons learned and recommendations for the future, and the EC is publishing soon its legislative proposal for the revision of the EU general pharmaceuticals legislation.  These are key opportunities we must seize to ensure that those whose responsibility it is to protect the public interest in general and public health more specifically are back in the driver’s seat.

Together, the learnings from these reports have informed a series of recommendations on access, transparency, and accountability that decision-makers should implement to reclaim control when it comes to public money, and ultimately – our health.

Our recommendations:

 

ACCESS: a clear path to medical countermeasures for all

  • The upcoming revision of the General Pharmaceutical legislation should create a more competitive environment, remove unnecessary barriers to competition and address abuses of the system and unfair practices. In particular, the EU should shorten regulatory protection periods.
  • When EU public funding is used to develop biomedical countermeasures, it must be accompanied by access conditions to guarantee the availability, affordability, and accessibility of medical products to all those in need, including to low and middle income countries.
  • In the framework of the renewal of the EU Global Health Strategy, the EU and its Member States must take concrete steps to ensure that medical countermeasures are available and accessible and affordable to all.

TRANSPARENCY to avoid corporate capture of EU processes

  • Any future preliminary negotiations held between the EC and pharmaceutical companies before contracts are signed should be conducted in a fully open and transparent manner and using established processes rather than informal channels.
  •  In the future, any official document bearing redactions should list the specific exception under Art. 4 Reg. 1049/2001 (commercial or decision-making) under which it was sought for each individual redaction, rather than for the document as a whole.
  • The upcoming revision of the General Pharmaceutical legislation should include specific measures to guarantee transparency of R&D costs in its revised incentives framework in alignment with the WHO Transparency Resolution
  •  The EU should champion strong transparency norms in the framework of the proposed WHO Pandemic Accord

ACCOUNTABILITY to ensure public interest remains the priority in all agreements

  • DG HERA should abide by high standards of transparency and accountability and disclose in a timely matter all documents related to its work, including past and future contracts, minutes of meetings and R&D agendas. DG HERA should ensure meaningful consultation with all relevant stakeholders. Whilst it should take into consideration a wide variety of interests, it must ensure public interest remains the ultimate priority
  • The burden of proof demanded under Reg. 1049/2001, Art. 4, should be reversed, with companies being required to prove that withheld information would damage their commercial interests. 
  • In the case of a conflict arising between an exception provided for under Reg. 1049/2001 Art. 4 (commercial or decision-making) with the overriding public interest, the latter should prevail.