Confusion, contradictions surround saga of medicine access and innovation study

By Amalie Holmgaard Mersh | Euractiv.com Est. 9min 23-11-2023 Content-Type: Analysis Analysis Based on factual reporting, although it Incorporates the expertise of the author/producer and may offer interpretations and conclusions. A STOA Panel meeting led by chair Christian Ehler (EPP). [European Union 2022 – Source : EP] Euractiv is part of the Trust Project >>> Print Email Facebook Twitter LinkedIn WhatsApp Telegram Clear contradictions, confusing communication and questions about the involvement of a major pharmaceutical lobby group in the publishing and unpublishing of a medical study filled the room at the latest meeting of the Panel for the Future of Science and Technology (STOA). STOA, which consists of a non-political secretariat in charge of commissioning scientists to conduct studies, as well as a political panel consisting of 27 MEPs, is supposed to provide the European Parliament with “independent, high-quality and scientifically impartial studies” to inform their work. However, a furore has emerged around one particular study, “Improving public access to medicines and promoting pharmaceutical innovation”, which was published and subsequently withdrawn – apparently against the panel’s own rules. The mess was only deepened in the STOA meeting held on Thursday (23 November). What do we know? On 19 October, the study in question was presented to the panel. On Friday 27 October, it was published on STOA’s website. However, to the surprise of many, by Monday 30 October the study had vanished again. This resulted in a tsunami of questions, many still unanswered, wondering why the official rules were not followed. In two statements, the STOA’s secretariat took responsibility for the subsequent withdrawal of the study. Later, a statement came from the STOA bureau – consisting of the Parliament vice-president in charge of STOA, Marc Angel (S&D), STOA chair Christian Ehler (EPP) as well as the two vice-chairs Ivo Hristov (S&D) and Ivars Ijabs (Renew) – in which they wrote that no rules had been broken. During the meeting on Thursday, a number of MEPs were fuming and more questions were raised demanding greater clarity on the process – in particular, whether intervention from the European Federation of Pharmaceutical Industries and Associations (EFPIA), Europe’s largest pharmaceutical lobby organisation, played a role in the study’s withdrawal. The theme of the study – access and innovation – feeds into some of the most fierce debates about the revision of the EU pharmaceutical legislation. And its findings are broadly unfavourable to the pharmaceutical industry’s arguments. On 25 and 26 October, just before the initial publication of the study, EFPIA sent emails, seen by Euractiv, to Ehler, alongside fellow EPP panel member Pernille Weiss, who is also the rapporteur for the pharmaceutical revision directive. In the emails, EFPIA attached a document with “a list of inconsistencies and flawed assumptions in the study” and lists points related to the methodology and content as suggestions for the two MEPs to raise when discussing the study with other panel members. Weiss and Ehler subsequently submitted questions to the study’s authors. A document from Thursday’s meeting, seen by Euractiv, in which the authors of the study answer the 20 questions by EPP MEPs Pernille Weiss and Christian Ehler, reads: “We thank the STOA Secretariat for sharing with us also some comments by EFPIA. However, as mentioned by the STOA Secretariat, we were not required to address them,” Simona Gamba, Laura Magazzini and Paolo Pertile, the study’s authors, wrote. Why the secretariat were the ones passing the emails on to the study’s authors is unclear. European Parliament welcomes, criticises proposed pharmaceutical package Members of European Parliament welcomed the proposed revamp of the bloc’s regulatory framework for pharmaceuticals during a discussion this week but did not shy away from criticising certain aspects. The Parliament’s Public Health Committee (ENVI) this Wednesday (20 September) opened one … Mysterious and contradictory When the study was first withdrawn, insinuations were made by POLITICO towards MEPs Ehler and Weiss that they had been a part of ordering it to be removed. More fuel was added to the fire after an email from Weiss to other panel members on 27 October – seen by Euractiv – showed her requesting the postponement of the study due to some written questions following up on things she asked during the study’s presentation. Both Weiss and Ehler have publicly denied any involvement in the study being removed. According to STOA’s official rules, to protect the independence of the study, panel members do not vote or adopt studies, nor are they allowed to postpone them. When the scientists, chosen by the STOA secretariat, have concluded the study and the secretariat deems it ready, it is published. Only if panel members ask for an external peer review according to article 6.4 can it be postponed. The secretariat sent out two statements, one on X (formerly Twitter) and another on their website, taking responsibility and saying the study was published prematurely. “It has been established practice in STOA that studies cannot be published without a decision of the Panel to approve the study for publications,” the website’s statement reads. “This was not the case for this study (as has been the case for other studies before). The procedures in STOA are in place to ensure that there is time for Members to raise questions and get them answered before authorisation for publications is given,” they add, seemingly contradicting the official rules. When asked about these procedures by Euractiv, the secretariat declined to answer questions on the record and could not point to where the procedures could be found. In the statement by the STOA bureau, the approach was similar. Both in the meeting on Thursday and speaking to Euractiv, MEP Angel emphasised the need for guidelines on how to interpret the rules due to different studies apparently following different procedures. “I think we need these guidelines to make sure that there is full transparency,” he said during the meeting, emphasising that MEPs should be able to ask questions, but that the panel should consider a timeline, so questions do not delay studies. There have been other instances of delays in study publications. During the meeting, Italian MEP Rosa D’Amato from the Greens referenced a study from earlier this year named “Decarbonising the fishing sector”, saying that it had been delayed by four months due to written questions. However, she said she did not know about them, adding that “if there were questions, I’d like to see them”. The questions on the fishing study could not be located by Euractiv on STOA’s website, and neither did the STOA secretariat respond to a request to see these questions by the time of publication. LEAK: Commission enlists help of stakeholders to reshape EU pharma sector The European Commission will call for “cooperation between different stakeholders to bring about positive change” in the pharmaceutical sector, according to a leaked communication accompanying the revision of the EU’s drug framework. Another round of contradictions From the very beginning, the pharmaceutical study’s lead Portuguese MEP from S&D Maria-Manuel Leitão-Marques has been puzzled about the obvious contradictions, as have a number of her colleagues in the panel. This was no different at the meeting on Thursday, where she attempted to get answers from Ehler, Angel and the secretariat about what was going on. “No STOA rules in my interpretation say that [questions] should be answered before the publication of a study. This would be a dangerous loophole to allow any member to delay the publication of a study if they do not agree with the conclusion of the study,” Leitão-Marques said in her introduction, asking for the answers to Ehler and Weiss’ questions to be put online alongside the study – which has now been done. Leitão-Marques also asked for the emails from EFPIA to be shared with all panel members and not just the secretariat, Ehler and Weiss. Similarly, the Green MEPs D’Amato and Michéle Rivasi repeatedly called for transparency and accountability about who decided to remove the study in the first place, and for any potential influence from lobbyists to be made public. “I’m quite angry with the administration because I don’t know what links you have with the chair, but there are things that aren’t very clear here,” Rivasi said, adding that only the panel members have the right to postpone studies by invoking article 6.4, which so far has not been done. “I have never seen an administration overriding political decisions. Never. You need to respect the rules,” she added. Austria, Germany raise pharma revision at EU Competitiveness Council Following competitiveness concerns from industry over the EU’s pharmaceutical legislation, Austria and Germany added fuel to the fire by bringing the topic to EU ministers in the Competitiveness Council on Monday (25 September). Final perplexing bookend By the end of the meeting, MEPs agreed to look into establishing guidelines for how to best interpret the rules – though it was rounded off by a final confusing episode, in which Ehler asked whether the study was now ‘endorsed’. According to STOA rules, MEPs do not have the jurisdiction to approve a study through a vote. “The endorsement is not an approval,” said Angel, in a feat of trying to stick to both what was in the STOA bureau statement and official STOA rules – while adding yet another layer of confusion to the meeting. “It’s just now the decision that we launched the procedure to publish it with all the questions […]. I guess you all agree with this or not. But endorsement does not mean that we had a vote on it because we don’t,” Angel continued. As the discussion came to a close, attention amongst the panel members turned to an upcoming STOA event about academic freedom. [Edited Giedrė Peseckytė/Nathalie Weatherald] Read more with EURACTIV Commission and pharma industry in dispute over R&D incentivesThe European Commission argues that the upcoming pharmaceutical revision must not favour incentives to industry over the availability of medicines, while drug manufacturers warn that in pharmaceutical research and development, Europe is already lagging behind major global competitors, the United States and China. Print Email Facebook Twitter LinkedIn WhatsApp Telegram Topics Access to medicines Christian Ehler Health Marc Angel Maria-Manuel Leitão-Marques Michèle Rivasi Pernille Weiss pharmaceutical innovation Rosa D’Amato STOA