The European Clinical Trials Regulation is reaching another milestone in its progress to the statute book. This week sees the deadline for amendments in the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) before a series of votes takes place on the European Commission’s proposals from last summer.
It was great to be able to participate in a European Parliament event on “what to expect from the revised legislation” at its London office last Friday. At a well attended and high powered meeting Stefano Soro of the Commission explained the purpose of the Regulation, and Glenis Willmott the MEP appointed rapporteur on the dossier spoke to her planned amendments.
There was a useful and practical discussion with the voices of non-commercial, academic and clinical perspective and I was glad that the BIA was able to give our members expert perspective, as the only industry body to contribute to the debate.
As such it was great to be able to highlight just how welcome this revision of the clinical trials directive is, because under the existing rules disproportionate regulatory requirements, high costs, and a lack of harmonisation has led to the number of clinical trials conducted in the EU falling by 25% between 2007 and 2011.
I was also able to highlight the fact that this proposal should make things simpler, easier, quicker and safer through the single submission via the EU portal, the single assessment report and a single outcome.
I was reassured that the rapporteur is supportive of the regulation and in particular understands the importance of the timeline for assessment.
However, I was able to voice the fact that some of the proposed amendments seemed to be viewed solely from what I’d call a “Phase III clinical trial” perspective by requiring clinical trial sponsors to publish a full clinical study report on the EU database. It is worth pointing out that these reports are prepared for submission to the regulatory authorities when applying for marketing authorisation. I think they miss the fragility of the current early clinical development process. The changing nature of drug development increasingly means many are now collaborations and partnerships between academia, medical research charities, SMEs and multinational biopharmaceutical companies.
Protection of know-how provides a key factor underpinning the funding of such partnerships. The detailed requirements for open publication set out in these amendments as the work goes along makes getting funding for such risky work even harder. This view was echoed by others from the non-commercial sector. The challenge of being able to obtain patent protection later in the product lifecycle after publication was also voiced, but Glenis Willmott surprised me by saying said she had heard from pharma that this was not a big concern. On the contrary the life sciences industry urged that a balanced approach is taken with regard to public access to information held on the European database concerning on-going clinical trials in the EU.
I fear the loss of such protection would dramatically impact upon investment into the sector, which cannot be made up by government funding alone, thus removing a key pillar for collaborative research and development of medicines designed to improve patient outcomes and care.
When Glenis Willmott was appointed rapporteur last October she said “There couldn’t be a better time to change these rules. If we get them right they could create many skilled jobs in the UK and Europe, as well as leading to new life saving treatments and drugs.” I agree – if we get them wrong by imposing new onerous rules that disincentive investors we will do the opposite.
So the upcoming debate on the amendments in the European Parliament is one to watch closely.