To celebrate this year's International Right to Know Day, the European Ombudsman, Emily O'Reilly, organised an event entitled "Transparency and public health – how accessible is scientific data?" The event sought to examine the importance of transparent scientific data, and more specifically clinical trials data. Patients, doctors, and researchers need it to make informed choices in relation to the medicines they take, prescribe, and analyse respectively.
The event took place on 29 September 2014 at the European Parliament in Brussels. It brought together representatives of the European Commission, the European Parliament, public affairs consultancies, legal professionals, industry, NGOs, journalists, researchers, and activists, attracting in total around 150 participants. The event was webstreamed live.
The speakers were: Margrete Auken, MEP, shadow rapporteur for the new EU Clinical Trials Regulation; Guido Rasi, Executive Director of the European Medicines Agency (EMA); Ben Goldacre, physician, academic, and author of Bad Pharma; and Richard Bergström, Director-General of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Frédéric Simon, publisher and editor of EurActiv, moderated the event.
Ms O'Reilly welcomed the participants, stressing the importance of transparency with regard to clinical trials data. Mr Simon cited the EU's new Clinical Trials Regulation, EMA's new proactive policy on transparency, the changing political environment, responsibility, and transparency, as some of the key elements for discussion. It took place in the wider context of the Open Government Partnership (OGP), whose objective is to render public administration more open, accountable, and responsive to citizens.
The European Ombudsman gave examples of the immense contribution of pharmaceutical research towards containing diseases and saving lives. Medicines have, for example, turned HIV from a terminal illness to a chronic one, thus enabling those infected with the virus to lead full lives. In addition, vaccines have, since the 1960s, practically eradicated killer diseases such as rubella, mumps, and measles, from developed countries. Ms O'Reilly then spoke of the importance of public trust in medicines, extensive peer review of pharmaceutical products, and improved transparency.
Ms O'Reilly reminded the audience of the role of her office, which is to ensure that the EU administration acts transparently and responsibly. She called on the EU regulatory agencies to adopt convergent policies on transparency. The Ombudsman opened three transparency cases concerning EMA in the past five months, the first of which relates to access to the clinical study reports of a medicine. She started the inquiry after EMA backtracked on disclosing the reports in full, after accepting an out-of-court settlement with the company marketing the medicine.
However, Ms O'Reilly commended the Agency for its commitment to proactive transparency. She announced that she would closely examine EMA's proactive transparency policy once it is adopted, to ensure that it meets the highest standards.
That clinical trials data is the property of patients, and not that of pharmaceutical companies, was the overarching principle of Ms Auken's message. For the MEP, transparency, which is enshrined in EU law, is for the good of patients and humanity in general. She criticised pharmaceutical companies for attaching too much importance to financial gain, to the detriment of human and environmental health. The MEP also said that pharmaceutical products are overpriced, and that conflicts of interest in industry-EU administration relations are rife.
Ms Auken stressed that except for a few small political party alliances, industry enjoys overwhelming support within the European Parliament. She also said that industry lobbied the new European Commission presidency to the point that it plans to switch responsibility for pharmaceutical matters from the Directorate-General for Health to that of Enterprise. She wishes to see more transparency regarding declarations of interest among policy-makers.
Mr Rasi named the high number of requests for access to documents in 2011as what prompted EMA to establish a new proactive policy. The Agency wanted to increase transparency in methodology and allow for public scrutiny, avoid duplication of clinical trials data, and foster new ideas and new research. The Agency's Executive Director explained that EMA's new proactive transparency policy aims at making data available only for research and non-commercial purposes. The policy clearly spells out redaction principles. EMA plans to start making clinical trials data available in 2015.
Mr Goldacre demonstrated how difficult it is to make informed decisions about treatment, as long as important information on the methods and results of clinical trials are withheld from doctors, researchers, and patients. Although he welcomed the new EU Regulation as a valuable step forward, he also pointed out enormous gaps it contains. The Regulation, for instance, does nothing to facilitate access to information on medicines that are already on the market.
Lamenting industry's active lobbying against change, Mr Goldacre specified that the registration of clinical trials, methods and results, study reports, and individual patient data should be disclosed. He warned against the sudden surge of interest of certain industry groups, such as Pharma and EFPIA, and patients groups, in the protection of individual patient data. Mr Goldacre interprets this interest as a strategy to impede the sharing of clinical trials data.
To highlight the importance of the pharmaceutical industry, Mr Bergström said that it spends 100 billion Euros on research yearly, compared to the EU's 15 billion Euros. He reported that pharmaceutical companies were already sharing data on a large scale, albeit selectively. Having committed to sharing data with all stakeholders in 2014, Mr Bergström said that industry's next step would be to start sharing data with civil society organisations.
With respect to study reports, the panellist said that EU law allows parts of data to be redacted to protect commercially confidential information. He also announced that most EFPIA members had promised to make historical data available, and that they would start publishing details of their financial relations in 2016.
Participants raised several questions and made comments, which mostly revolved around conflicts of interest in the EU administration-pharmaceutical industry relations, the need for a convergent policy between the EU regulatory agencies and chemicals and pharmaceutical industries on transparency, and the influence of pharmaceutical companies – on both sides of the Atlantic – on the Transatlantic Trade and Investment Partnership (TTIP) negotiations.
Attendees also spoke of the need for the public to scrutinise the pharmaceutical industry's activities, to involve specialists in risks-benefits assessment, to hold more public hearings with stakeholders, to disclose information on the adverse effects of medicines, and to safeguard the rights of patients.
You can watch the event at: International Right to Know Day, 29 September 2014