Our VP of Life Sciences, Paul Ireland, was at the TOPRA 2018 Symposium in Stockholm, Sweden from October 1st – 3rd to hear and discuss the latest news and initiatives within the pharmaceutical industry together with Life Sciences regulatory professionals from Europe and around the world. Due to the wide-ranging ongoing initiatives within the regulatory space across all divisions of Life Sciences, the conference was split into multiple tracks:
- Human medicines
- Medical devices
- Veterinary medicines
From the initial introduction by Lynda Wight from TOPRA, it was clear that the topic of Brexit would have a role in many of the discussions during the three day agenda.5 Key Takeaways
Some key takeaways from the discussions were:
- Brexit has far reaching implications beyond just the UK. Within the regulatory space, the pain of the decision to leave the EU is being felt by all other EU health authorities who are having to pick up additional workload that the MHRA was previously undertaking on already constrained budgets.
- It is a time of substantial change within the Life Sciences industry. There are many industry projects and initiatives ongoing. These have timelines that are also being affected by Brexit:
- New Medical Device Regulation (MDR)
- In Vitro Diagnostic Regulation (IVDR)
- Clinical Trials Regulation (portal)
- Substance, Product, Organisation and Referential (SPOR)
- New Veterinary Regulation
- International Coalition of Medicines Regulatory Authorities (ICMRA) and ICDRA
- With change comes opportunity. Despite the “patchwork” of changes that are being implemented and some of the complexities that arise because of that, the many updates and new approaches being implemented provide opportunities to improve processes and the overall safety for patients in the end.
- The EU needs to evolve more quickly or risks falling behind the rest of the world. There was some debate about whether the EU should speed up their approval processes, as it was pointed out that the number of new drug approvals isn’t necessarily a good measure of success for any health authority and society in general. The process needs to remain safe, but some felt that the FDA and China are moving ahead, and even typically slower regions such as Japan are making great strides in their time to market. The complexity of the many different European member states, procedure types, etc. doesn’t help, and Brexit reared its head again as another current hurdle in this regard. It was agreed that the many initiatives would help support this, as long as they can be implemented quickly enough.
- Global cooperation is critical in the regulatory landscape. There was an agreement that the more initiatives and results from one region can be leveraged in another, and the less “re-inventing of the wheel” the better. Upcoming markets in Africa for example are beginning to look at the EU regulatory models- rather than the traditional approach of following the US FDA- due to the multi-country similarities between the continents. Skills in these emerging markets are also now recognized as being extremely high, so talent is available from a broader audience than previously, which will be important with the many cross region initiatives and platforms that are taking place.
It was a time to reflect on not only how far we have come, but also acknowledge how far we still have to go. Figures highlighting the fact that 39 centrally approved medicines remain at risk of supply disruption or shortages across the union after Brexit are a sobering takeaway from the event. Even if that number was originally 108 medicines only months earlier after the initial review by the EMA. Business will continue after Brexit and the many initiatives discussed during this event will progress considerably more rapidly once the uncertainty of Brexit is part of the “how far have we come” to our story. Many exciting new complex and innovative products which are in production or development will benefit from the many changes that we will see in the coming years. The Life Sciences industry will have to change rapidly to keep up, but we will get there.