The task of bringing new medicines to market represents a transatlantic regulatory challenge. According to global healthcare giant Roche, the solution may lie partly in reducing the discrepancies between EU and US approval pathways.
WORKING TOGETHER TO GET MEDICINES TO MARKET G
etting new medicines to patients as quickly as possible is a priority for Roche and the industry. It is therefore a very positive development that new regulatory pathways have been put in place in both the US and the EU that aim to address this need. However, according to Sabine Atzor, head of EU Regulatory Policies in Roche Pharma Development, “Data show that in recent years it seems to have taken significantly less time to get marketing approval for a ‘new medical entity’ in the US. For European patients who urgently need new therapies, for instance to treat cancer, this relative delay in access may have a significant health outcome impact.”
Why the transatlantic discrepancy? Three factors are likely to be the main reasons behind this. The first is that the US and EU regulatory authorities have different processes 14 Industry Europe
in place to address unmet medical needs in serious or life-threatening diseases such as cancer. The US has established a number of pathways – Fast track, Breakthrough Therapy Designation, Accelerated Approval and Priority Review – that ultimately allow for a more rapid review of a drug. In the EU there is Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances, and Accelerated Review. While these pathways have similarities in many respects, there are still fundamental differences between them leading to different timelines and outcomes in practice. As a result, streamlined cooperation between the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) – which would permit a more aligned approach to new drug approvals between countries – remains a challenge due to a lack of synchronisation. An alignment of procedures would be an ideal
situation, and one that Roche would readily support, but this would certainly require a major political effort to make a reality. Secondly, there are key differences in how decisions are made locally in terms of drug reimbursement, which ultimately determines how and when patients can access them. These decisions remain fragmented in the EU due to responsibilities at national level. Finally, it appears there may be differences between the EU and the US regulatory authorities on how they apply the precautionary principle in regulatory decision-making. According to Sabine Atzor, “To be able to achieve the ultimate goal of maximum health benefit in this context, excessive risk aversion should be avoided. This requires an ongoing exchange on regulatory, scientific and ethical perspectives across regions to enhance mutual learning – an exchange into which Pharma companies are well placed to add value.”
