Greater Transparency is Needed

We should not accept not having access to the conditions for purchasing vaccines, on which public centres worked.

Itziar de Lecuona, Associate Professor, School of Medicine and Health Sciences and Assistant Director Bioethics and Law Observatory UNESCO Chair in Bioethics at the University of Barcelona 

Protecting the health and welfare of its citizens is a priority for the European Union. To achieve this goal it is necessary to strike a balance between the rights and interests involved. To face up to COVID-19, research should be carried out transparently with a view to obtaining vaccines and distributing them. This way, trust will be generated in science and in the political managers responsible for developing vaccines and making them accessible.

It is a priority task during a pandemic, which requires the participation of different actors with interests that are not always aligned. The public interest often clashes with private interests. The European Union pursues a single competitive market in which health is an asset and not just a commodity. For this, public and private initiatives must go hand in hand. The pharmaceutical industry is however not just any actor; one only has to analyse the applicable laws on medicinal products for human use and take a look at the industry’s parliamentary lobbies to realize how influential it is.

Biomedical research in which people take part, and in which biological samples of human origin and personal data are used, must meet a series of methodological, ethical and legal requirements that are assessed fundamentally by research ethics committees. These have to check that the proposed intervention complies with the criteria of scientific validity, social relevance and respect for the rights of those taking part – and their autonomy to make decisions, after receiving the appropriate information about the possible benefits and risks involved in the research.

The benefits must be maximized and the risks minimized. Furthermore, the research must respect the principle of justice in the recruitment of participants, in access to the results, and in the sharing of benefits from any scientific research – the vaccine in this case, and not just for Europeans! Moreover, the principle of transparency makes it necessary to identify and avoid possible conflicts of interest of researchers and research institutes.

The law establishes that the data from clinical trials must be registered on public databases and that their results – both positive and negative – should be published in scientific journals. In Europe we still do not have a public database, even though it has been legally green-lighted since 2014! These examples make it possible to gauge the existing tensions.

It is time to demand compliance with these requirements, which are applicable with and without COVID-19; to bring science closer to society and to establish a real dialogue between the different actors. This is not happening. The European Union promotes “responsible research and innovation”, at the heart of which is the public’s engagement in the processes of creation and knowledge transfer, as well as ethics, open access, gender equality and scientific education. It is unacceptable for the health commissioner to refuse to disclose the agreements made with different pharmaceutical companies to purchase vaccines in advance, despite the fact that the European Parliament has called for greater transparency in these matters.

Research in our field is carried out in public and private institutions, and is funded largely by the taxpayers. They could be invited to participate as human subjects in clinical trials to develop vaccines out of solidarity to test them and to check interventions and treatments that could be directly or indirectly beneficial. The merit of developing vaccines cannot be attributed solely and exclusively to the pharmaceutical industry. The work of cutting-edge research teams from public and private centres, which the industry identifies to promote clinical trials, must also be acknowledged. Then there are the patients and the healthy volunteers who are prepared to take part.

Research to develop medicines and vaccines is therefore a shared social responsibility to meet the most pressing needs of our time. We should therefore not accept not having access to the criteria and the conditions in the contracts negotiated by the European Union for purchasing and distributing vaccines. Nor should we continue in our state of ignorance about how the processes of research and knowledge transfer work in health. Information and scientific education could help us to make free and informed decisions in order to move forward in the management of the pandemic.

• Opinion article published in El Periódico on 23 december 2020.