EPHA’s submission to the feedback mechanism on the on the HERA (Health Emergency Preparedness and Response Authority) inception impact assessment
The COVID-19 pandemic has shown that Europe has paid the price of not being prepared in the biomedical research & innovation (R&I) front. Moreover, the lacking supply and grossly inequitable global access to Covid19 vaccines is a stark reminder of why such fundamental public health questions must not be left to a profit-driven industry to decide.
HERA is a great opportunity to build on the excellent European science, to learn the lessons from the ongoing crisis and ensure that the public acts as a wise investor which steers meaningful, public health needs-driven innovation.
It should be a purely public organisation with a clear public health mission, not to be conflated with areas of industrial policy. It should have a sizable budget which will provide for independent long-term planning. In acting as wise investors, governments should be ready to invest significant amounts of public money. They should be mindful of the fact that not all R&D projects will come to fruition and some of them will not deliver the desired results. The possibility of failure and the financial risk should be endorsed from the start, especially, as HERA will invest in risky competitive projects including the boosting of manufacturing capacity.
The new Agency (option number 3) will have to be independent, sustainable and protected from political pressure and evolving political priorities, jeopardising the continuity of its work. It should address the current lack of coherence between EU and national funding schemes and ensure that discoveries made with the support of EU funds will be translated into large scale industrial development across the EU.
HERA should have enforceable rules on Open Access (i.e. data sharing) following Horizon Europe. HERA should build on – but go beyond – existing access initiatives (e.g. the Medicines Patent Pool) and develop more transparent and efficient incentive mechanisms that de-risk private sector activity but at the same time guarantee universal access and public return on public investment.
Its governance structure should be transparent and balanced, including patient, public health organisations, and representatives of the research community. Whilst the industries will be important partners, they should not be part of any governance structure of this new public organisation. The definition of global unmet needs will be done by the public health sector only and the goal will be to engage in the development of new products to bring them to the market. This means that HERA will go well beyond the Innovative Medicines Initiative (IMI). The EU should be willing to exercise judgment that is independent of the pharmaceutical industry, and design solutions that are public health driven (for example, in the field of tackling AMR). It also means that affordability, availability, accessibility, socially responsible licensing and transparency conditions will be attached to the end products to reflect the substantial and multifaceted public support and investment. To this end, reasonable pricing clauses should be envisaged.
HERA will not only need to coordinate with the European Medicines Agency and the European Centre for Disease Prevention and Control but also will have to integrate and streamline efforts throughout the value chain from basic research to large-scale manufacturing and distribution, across public and private sectors. Building of vaccine manufacturing facilities that are on standby to be mobilised in response to emerging infectious threats should be considered as the covid19 vaccine debacle has proven that rapid vaccine production at scale is a major challenge. At present, the landscape of EU research funding instruments is quite fragmented and insufficiently driven by the principle of public return on public investment. HERA can be instrumental in aligning means with priorities with a clear legal framework, a substantial, sustainable budget and a strong leadership for a new independent and autonomous Agency with a clear public health mission.