Debate in European Parliament Environment and Health Committee on Clinical Trial Regulation 19-2-2013
Today the first major discussion on the future of clinical trials in the EU took place in the lead committee on this legislative report. Rapporteur Glenis Willmott defended her amendments to the European Commission (EC) proposal and 15 MEPs took the floor to give the opinion of their political groups and to explain some of the amendments they will be presenting over the next 10 days. The final vote will take place on the 25th of April and then the Parliament will try to negotiate a final common text with the Council that represents EU member states.
In general the debate three different camps with regards to transparency and access to clinical trial data: The S and D rapporteur Wilmott and others who support the requirement of an accessible clinical study report (CSR), some leading conservatives and liberals who do not want much greater transparency and Greens and Leftists who request open access to raw data, as well as CSRs.
A number of conservative EPP and liberal ALDE MEPs (but not all) expressed their reservations about any significant change in the status quo due to issues of competition, cost, administrative burden and, generally, no real need of greater openness requirements. French Conservative Juvín and Bulgarian liberal Parvanova, who represent their political groups that together represent a majority, do not support the demand of a clinical study report and more or less favour the status quo. Nevertheless, others in their groups seem to be more in the transparency camp.
Danish Green Auken and Portuguese Leftist Souza were very clear in their support of open access to data, ethical practices and transparency.
There was a general opinion of all the groups that the role of ethics committees in the proposal has not been clarified nor given the importance they merit.
Willmott opened the debate by speaking of the positive aspects of the EC proposal with reference to “low intervention trials”, less administrative burden and the need to respond to the decline of clinical trials taking place in the EU. She expressed her opinion that trials taking place outside the EU should adhere to EU standards and the Helsinki Declaration in order to be eligible for authorization in the EU.
On transparency Willmott said there was a major problem of lack of public trust due to selective reporting that magnifies the efficacy and hides the secondary effects of new medicines. Willmott stated that “summaries are not enough” and that complete clinical trial reports are needed. She insisted that independent researchers must have access to this information that is not such a burden because most researchers produce it already. According to Willmott sharing is win-win situation that will increase trust in the scientific process.
Phillipe Juvin for the conservative European Peoples Party said that “some data should be available, but not too much data, too complicated for the public to understand” and stated that Willmott went “too far in asking for complete clinical study reports”.
Juvin also requested much lower reporting requirements for clinical trials on medicines that already have an authorization because “the risk is almost zero”.
Parvanova for the ALDE liberal group is in favour of ethics committees on national levels. She asked: “What is a CSR? Who will get this information? What can be disclosed before and after authorization?”. Like Juvin Parvanova said “it is not convenient to give the public too much data.” She spoke of the dangers of “anticompetitive practices” but spoke favourably about allowing data to be used by “independent experts.”
Margrete Auken for the Greens stated that the “results belong to society, not to the industry”. She believes the regulation is an “historic opportunity” to save billions of euros and thousands of lives. “Industy now has the chance to prove they are concretely in favour of transparency” she added. She cited the recent vote in the Bundestag in favour of strong ethics committees. She mentioned major scandals due to the lack of transparency with regards to Tamiflu, anti-depressant drugs and other medicines. She said that when health is at risk, like in human clinical trials, ethics must come before economic interests.
Souza for the United Left group said that the EC proposal was regressive by weakening ethical opinions, eroding informed consent and, in general, demanding more lax obligations than the present directive. It will promote trials in countries with the most lax rules. She quoted experts who say that the EC proposal contradicts the Helsinki Declaration.
German conservative Liese also said that the EC proposal protected people less than present law. Liese is specially concerned about “loosened rules for children in clinical trials”. As opposed to Juvin, he supports Willmott on transparency and access. He even insists on the need for access to raw data.
French liberal Lepage also disagrees with her liberal colleague Parvanova in supporting clear ethical rules, openness, transparency and “early detection of secondary effects of drugs”.
French conservative Grostette was quite adamant in defending the status quo as far as transparency goes due to patent conerns, data protection (rare diseeases) and the high cost.
Polish conservative Hubner gave the most radical defense of the Pharma industry by accusing some other MePs of treating the industry as “a criminal group” when we are only considering “procedures carried out by scientific specialists.” Hubner stated that “more access to information to unqualified persons would provoke consumer scare.”
Tommorrow the EP´s Industry Committee will consider its opinion on the Clinical Trial Regulation.