On November 28th the Commons Network and Universities Allied for Essential Medicines organized the event “Open medical science for better health-care for all: Making Horizon Europe work for the public interest” in the European Parliament. Sponsors of the event were MEPs Lola Sánchez Caldentey, Guillaume Balas, Margrete Auken and Michèle Rivasi. Speakers included Jill McArdle (Global Health Advocates), medical researcher Peter Gøtzsche, Peter Grabitz from Universities Allied for Essential Medicines (UAEM), Ellas Papadopoulou on behalf of DG Research and Innovation, MEPs Magrete Auken and Guillaume Balas and Sophie Bloemen from Commons Network.
“As open as possible, as closed as necessary” is the new slogan being used by European Commission and European Parliament research and innovation policy-makers concerning the degree of openness or closeness of EU science and innovation. It means “let´s share scientific knowledge openly but only when it also benefits large EU private industries.” This “not-so-open” EU scientific policy has profound impacts on initiatives for biomedical and health-care research in the public interest. The fight for open science is the also the struggle for greater access, availability and affordability of medical knowledge and products.
Obviously, the medical science commons has many contentious political fronts. EU financed health-care research can have important impacts on what areas are researched, who owns the knowledge generated in the results and how affordability criteria (or the absence of) can condition the transfer of medical technologies to the market.
While we can see many advances locally with bottom-up, collaborative forms of democratic and collective management of medical knowledge, the European political sphere has become a battleground in which large market forces allied with major EU governments are still successfully erecting walls to further enclose what should be open for all to share for the improvement of public health. As well, there exists a wide, plural debate on how we can advance medical research and innovation model that independently produce scientifically reliable information on the safety and efficacy of medical products for patients and doctors. Transparency, clinical methodologies, conflicts of interest policies and broad citizen-patient participation are some of the key topics for the medical knowledge commons now being hotly discussed in the health-care research community.
Openness for health-care in the public interest should be one of the priorities of the EU´s future science and innovation programme, Horizon Europe, but the strong influence of industrial lobbies has heavily conditioned the legislative outcome for “open science” in the European Parliament despite “open science” being one of the declared flagships of EU research policy. Open Science Policy is part of the EU’s Digital Single Market Strategy. The logic of underlying this strategy is that of growth, markets and competitivity. Within this frame it near to impossible to pursue objectives such as social wealth, inclusiveness or equity, that are not in line with this logic. “Open science” policies referring to “open access”, “open data”, “citizens science” and intellectual property rights, have been undermined by the overriding focus of EU institutions on competitivity, economic growth and industrial innovation.
There is presently a strong push-back against a series of open scientific regulations established in the previous EU framework programme for research, Horizon 2020 that spanned the period 2014-2019 in favour of the public interest, social inclusiveness and democratic participation. One example is the crucial debate that has surfaced in the draft proposal for Horizon Europe supporting the chemical lobby-promoted “innovation principle” that aims at weakening the legally enshrined “precautionary principle”, a tidal pro-business shift that could undermine important public interest and consumer safeguards that protect health and the environment from potentially dangerous products.
Also worrying is the long exhaustive list of industry promoted exceptions and opt-outs to applying “open access” publishing and “open data” obligations which will most probably be included in the next Horizon Europe programme that could cripple or at the least greatly jeopardize these open science objectives. The very successful EU citizen science programme “Science with and for society” has also had its budget line eliminated from the Horizon Europe proposal. While Horizon Europe is expected to have indicators of societal impact, in the policy priorities of Research and Innovation there are few mentions of societal challenges or global relevance (SDGs), quality of life or wellbeing and the involvement civil society organizations in this EU framework program which is critically low.
What is probably most disturbing is the lack of a broader public debate on EU scientific priorities nor even a minimum degree of public awareness of the current “counter-reform” underway, much of which has gone forward under the radar of the press, social media and large NGOs.
Although openness remains a priority, in order to steward medical research in the public interest, we should perhaps also go beyond the concept of open, as openness is not always best suited to steward results. Managing knowledge as a commons on the other hand, also moves away from privatising knowledge, yet implies a governance that includes a certain stewardship, which sustains resources over time and ensures their protection. It implies the participatory management of knowledge in vetting its accuracy, assuring its accessibility and hosting public dialogue about it. Commons governance as such also involves creating structures , channels and organisational pathways to enable participation in re-interpreting , re-creating and integrating knowledge into socially and ecologically meaningful contexts. Development in the area of data commons or data trusts are insightful in this sense and it would be positive if the Open Science Cloud the Commission is setting up would be conceived as a knowledge commons.
David Hammerstein, Martin Bogdan, Sophie Bloemen
Here are some short video interviews of some of the participants:
Expert table: Open science for better health-care?
During the closed expert round table the same day of the public event, the discussion focused on medical research and access to medicines (link to report below). A number burning issues related to open medical science for better health-care were discussed extensively by the experts present in the European Parliament. This discussion centered around new models of biomedical innovation without patent monopolies, conflicts of interests of medical professionals, researchers and medical schools, transparency of clinical trial results, the credibility of journal articles used for systematic reviews, the involvement of patients and citizens in the evaluation of medicines, pharmaceutical marketing at health-care centres and how global health priorities can be given priority over purely commercial interests.
There was an overall stress on transparency, limiting conflicts of interest and new innovation models without patent monopolies. Some participants stressed the need to go beyond expert-centered science and to put data into the hands of patients and citizens for better health-care decisions that include broad-based democratic debate. There was agreement that industry controlled research was a structural problem but not the only source of bias and distortion of scientific medicine.
There was a long, detailed debate over what methodologies should be used to study the efficacy of medical treatments. There was a consensus concerning the lack of credibility of systematic reviews on the safety and efficacy of new treatments that depends exclusively on medical journal articles and that ignores clinical trial reports and data that can give very different insights. What also needs to be declared in any study is the degree of availability or not of clinical trial data in order to evaluate the validity of any systematic review such as Cochrane reviews.
All participants agreed that industrial conflicts of interests were important and needed to be greatly limited while some participants insisted that if there is sufficient transparency and access to important clinical data carried out by industry, independent scrutiny can discover possible flaws, biases and weaknesses on the efficacy and safety of a product.
More detailed notes of the meeting can be found here.