The European Commission recently launched the new EU Health Emergency Preparedness and Response (HERA) and unveiled its proposal for a new framework to be used in times of health emergencies. HERA will be an internal service within the European Commission – rather than a standalone agency as previously announced. It will carry out an important set of tasks and has been allocated a substantial budget to make the EU better prepared to quickly respond to future health threats. HERA’s main goal will be to ensure that vaccines and other medical countermeasures can be rapidly developed and manufactured and are readily available for EU citizens. But whether and how HERA will ensure that such critical tools become available for the rest of the world remains an open question.
The EU’s vision on HERA recognises the value of international cooperation and the global nature of health threats. The proposal for a Council Regulation is permeated by the mantra that viruses and other pathogens “do not recognise frontiers”. Operationalising this vision will however require that critical medical tools are made accessible across the globe. The EU should also consider the mantra – well rooted in scientific evidence – that “no one is safe until everyone is”.
Effective mechanisms to ensure global access for vaccines and therapies developed with the help of public funding are and will be crucial to avoid current global vaccine inequities – where around 60% of people living in high-income countries have received at least one dose, compared to only 24% in middle-income countries and less than 2% in low-income countries. Leveraging this opportunity has not been the case with the COVID-19 crisis.
Pharmaceutical companies have received substantial public money both as direct support for their R&D efforts and through advance purchase commitments. The experience of the US Biomedical Advanced Research and Development Authority BARDA (after which the EU HERA is being modeled) shows this. BARDA provided significant funding for vaccine companies allowing them to de-risk their investments without clear obligations for companies to ensure access for the rest of the world. The US BARDA prioritised “America First” and has faced problems with the lack of incorporation of clauses in contracts negotiated with pharmaceutical companies.
Earlier this year, the European Alliance for Responsible R&D and Affordable Medicines shared its vision for HERA. Civil society organisations highlighted that HERA should treat the results of the activities it funds as global public goods. From a practical point of view, this will require that HERA includes clauses to protect the public interest in its contracts with private companies. Among other issues, these contractual obligations should ensure the affordability, accessibility and availability of medical countermeasures, introduce open access and open data requirements, prioritise public ownership, control and management of resulting intellectual property rights when possible, or use equitable licensing clauses in other cases.
If the EU wishes for HERA to become a truly global project, it will need to treat the medical tools resulting from public investments as global public goods.