Thanks to the European Parliament Special Committee on the COVID-19 pandemic for this opportunity to share our feedback. We believe that meaningful engagement with civil society is key to strengthen democratic processes and improve policymaking.
The European Public Health Alliance (EPHA) is a public health stakeholder in Brussels established three decades ago to advocate for better health (in Europe). EPHA covers a broad range of public health topics, with health inequalities as our flagship area.
Our input reflects our experience and the diversity of our members, which include around 80 health professionals and patients’ organisations, health NGOs and an array of organizations representing vulnerable population groups – including children, elderly, homeless, drug users, AIDS, Roma communities, gender focused organizations in the EU and Europe WHO region. EPHA is an independent, not-for-profit organization that receives no funding from industry. This ensures our impartiality in carrying out our public interest-oriented mission.
EPHA’s work on access to medicines is developed with our members and includes hosting the European Alliance for Responsible R&D and Affordable Medicines.
I would like to focus on 3 core areas in which EPHA and its members and partners have worked and formulated recommendations for the future: (1) ensuring public returns to public investments; (2) ensuring transparency and accountability, and (3) some implications for global access to vaccines.
Public return to public investments
A key problem during COVID-19 was the lack of conditions attached to public investments in various initiatives. Since the beginning of the pandemic, we recommended that EU institutions and national governments incorporate collective, pro-public safeguards, such as transparency regarding public contributions, accessibility and affordability clauses and non-exclusive licences for exploitation of end-result products, in funding calls and investments. This would have limited the shortcomings of market exclusivities associated with a single exclusive licence – such as excessively high prices or over-reliance on a single source, which may increase shortages. These measures are necessary to ensure that medical tools reach those in need but also to guarantee returns on public investments. The EU and its member states mobilized substantial funding to accelerate the development of vaccines, therapies, and diagnostics, including through the Innovative Medicine Initiatives (IMI). However, compared to other initiatives, such as the Coalition for Epidemic Preparedness Innovations (CEPI), these calls did not include clauses to guarantee affordability and access to the eventual end product (e.g., vaccines, therapies).
The Health Emergency Preparedness and Response Authority (HERA) offers further opportunities to make progress on this front. As civil society, we have emphasised that HERA should serve patients and promote public health. To do so, HERA should place emphasis on access, consistent with the need to recognize the crucial role of public R&D investments in biomedical research, including by using clauses guaranteeing downstream access and affordability, as well as the transfer of manufacturing know-how to third parties to achieve greater scale and faster delivery of products.
Similarly, conditions should have been included in Advanced Purchase Agreements (APAs), which were also a part of a strategy to provide upfront financing for Covid-19 vaccines to accelerate their development and availability. APAs helped by diminishing the risks for companies through upfront payments to speed R&D and commitments to purchase products when they are developed and authorized. This is crucial during a pandemic. However, the conditions included in APAs show that in most cases, IP rights – including know-how and data – remained in the hands of companies.
Lack of transparency further contributed to an unbalanced result
EPHA, along with other organizations called for more transparency on the governance of the European vaccines strategy’s Advance Purchase Agreements (APAs) mechanism used by the EU to procure vaccines for COVID-19. One key reason is that trust and accountability need to be upheld to safeguard and promote public health, the quality of healthcare systems, patient, and consumer safety. Overall, we need of transparency at all levels: who negotiates, what is being negotiated and agreed on, what are the costs (e.g., R&D, clinical trials, production). We also need transparency of data from trials and research projects financed with public money as this is essential for future planning and to build confidence in health products.
Likewise, we have also insisted on the need for HERA to have a transparent and accountable decision-making process along with autonomy to allow it to take risks by following a portfolio management approach while remaining accountable to the public. Beyond transparency in contracts, we have also advocated for transparency in the pharmaceutical sector, as opacity is currently the rule, and as foreseen in the WHO transparency resolution (WHA 72.8).
Equitable access to vaccines worldwide: vaccines as global public goods.
Beyond equitable access across the EU, global access to vaccines is crucial for an effective pandemic response, and in line with solidarity values across the EU. The EU and many national leaders committed to contribute to global access to vaccines worldwide and promised that COVID-19 vaccines would be treated as global public goods, meaning that they would benefit everyone around the world. This was also included in the agreement between the Commission and the EU Member States, which is attached to some of the APAs.
Learning from the pandemic will require the integration of EU policies that have an impact on global access to medicines. From the new EU global health strategy to the negotiation position of the EU on a potential Pandemic Treaty, it will be important to avoid that trade and industrial policies come before health. Safeguards to protect public health and the public interest are a crucial part of the balance between innovation incentives and access to affordable medicines.
We have a collective responsibility to identify and assess what did not work well, not to blame anyone but to learn from mistakes and avoid repeating them in the future. We trust that the work of this special committee will contribute to shedding light on these issues and open the door for more efficiency along with more transparency, accountability, and global solidarity in the future. We (EPHA), our members and partners, remain available and open to provide further comments after this hearing and to support the work of this committee.