50 years of pharma legislation has been beneficial, but Europe needs to keep its foot on the gas
09.04.15
The event, entitled “50 Year Anniversary of EU Pharmaceuticals Legislation: Are expectations for access to innovative medicines and sciences being met today?”, was held in Brussels, Belgium, on 18 March 2015, hosted by the EU Representation of Bavaria and co-sponsored by EFPIA.
Its main focus, principally the balancing of legislative requirements and expectations of healthcare stakeholders going forward, was emphasised by Bavarian State Minister for Health and Care Melanie Huml in her opening address.
Keynote speakers Severin Schwan, CEO of Roche, and Andrzej Rys, Director at the Commission’s DG Health & Food Safety, both emphasized the need to intensify efforts to harmonise various aspects of the regulatory and reimbursement frameworks in Europe. Stability and consistency, they argued, would benefit industry and patients alike.
Schwan was clear about the positive effects that European legislation has had on the region in terms of the delivery of high quality healthcare and the growth of a vibrant industry that is capable of improving on this solid foundation.
However, he was equally emphatic that there could be no complacency going forward, and that the EU was in danger of being consistently out-performed by the US with regard to a number of regulatory aspects, including approval times. As an example, he said that in Europe it took an average of six months longer to approve a novel cancer treatment than in the US. This was a matter that needed to be addressed swiftly, if Europe were to have a chance of keeping pace with its transatlantic counterpart, he said.
Some ground is being made up, though, with the European Medicines Agency’s drive towards implementing the Medicines Adaptive Pathways to Patients project, he conceded. The point is, though, that Europe has to be committed to implementing this effectively. The greater flexibility offered by the proposed system would help to speed drugs to market for the benefit of patients.
Schwan added that discrepancies in health technology assessment practices were also delaying the provision of novel medicines to patients. Assessments in many EU member states are inconsistent and used simply as a bargaining tool to pressure prices, he argued.
He decried the fact that HTA assessors could refuse to accept the results of scientific evaluations already undertaken by the EMA and would often duplicate the work, yet arrive at a different result that was ultimately detrimental to patient care.
This was a stance supported later in the panel discussion by Peter Liese MEP, a member of the European Parliament’s Committee on Environment, Health and Food Safety.
Meanwhile, Andrzej Rys lauded advances in EU regulations that have promoted paediatric and orphan medicines, and acknowledged that the MAPPs project was going to be a significantly beneficial vehicle to apply the same success to a wider range of innovative medicines.
It was all the more important to get this right, he suggested, because the
Innovative Medicines Initiative, the public-private partnership launched in 2014, with a budget of €3.3 billion, was beginning to bear impressive fruit. He suggested that, as projects within this framework progressed, the patient would come into tighter focus.
The European Commission is also keen to ensure that novel medicines can be delivered to patients across all 28 Member States efficiently and equitably. It has therefore established a group of experts on Safe and Timely Access to Medicines for Patients (STAMP) to optimise the use of regulatory tools to promote access.
It will necessitate an improvement in information sharing and cooperation between Member States. Through STAMP, synergies with other EU groups such as the HTA network or the Network of Competent Authorities on Pricing and Reimbursement (CAPR) can be created, he suggested. Preliminary results will be reported within a year, Rys said.
In the panel discussion, Rys and Schwan differed on the positions of the FDA and EU, with the former saying they could not be compared accurately, while the latter defended his original assessment.
Michael Doherty, Roche Global Head of Regulatory Affairs noted that, with the advent of big data – the gathering of large data sets in real time – clinical practice would evolve significantly. Evidence generation in smaller patient subsets was likely to transform the randomized clinical trial as we know it, he suggested, requiring changes to the supporting regulatory processes.
Summing up, EFPIA Director General Richard Bergström stressed the need for an integrated European Life Sciences approach. He suggested that this would ensure that all stakeholders keep pace with the fast evolution of science and biomedicine. He added that, by including patients in trial design at the earliest stage, trust would increase. Finally, Bergström said that there was an urgent need to promote the global competitiveness of EU pharmaceutical manufacturers to benefit both patients, through swifter access to new medicines, and the European economy as a whole. The EU, he concluded, should work harder to retain pharmaceutical R&D in Europe.