Independent committee report seeks Brexit healthcare clarity

pharmafile | March 21, 2018 | News story | Medical Communications, Research and Development ABPI, UK, biotech, brexit, drugs, pharma, pharmaceutical 

An independent report, entitled Brexit – Medicines, Medical Devices and Substances of Human Origin and written by the Health and Social Care Committee, has called for greater clarity regarding the future for medicine access post-Brexit.

The committee puts forward that this should be one of the major issues in negotiations, given that the health of the entire UK populations rests on the outcome of talks on this area.

Fears are beginning to mount over the regulatory pathway that could be faced by the UK if it falls outside of the single market and lies outside of the jurisdiction of the EMA. It could see a two-step process whereby pharmaceutical companies have to approach both the EMA and the UK’s MHRA to begin providing patients access to medicines.

Another area of concern is the future of medicine research in the UK, such as how will patients’ access to clinical trials change post-Brexit.

The report cautioned against preparing for a worst-case scenario, stating: “Far from undermining the UK’s negotiating position, we consider that clarity about contingency planning is necessary to guarantee patient safety and continued health supplies. There are implications for research and development, safety and supply chains for people and health systems both here and across the EU-27. We believe that it is important that both sides acknowledge this and remain firmly focused on the needs and safety of patients.”

Some of the sticking points that lay ahead for negotiations rest on what model the UK wants to pursue in regards to the future UK-EU relationship over medicines and medical devices.

Michel Barnier, the EU’s chief negotiator, has stated that the UK has only two options: to follow either the Canadian or Norwegian model for access. Both of these have already been rejected, publicly, by Theresa May and instead wants an agreement tailored to the UK – a position that the EU rejects.

Mike Thompson, CEO of the ABPI and Steve Bates, CEO of the BIA, released a joint statement on the report:

“This thoughtful Select Committee report makes a compelling case to Brexit negotiators why public health and patient safety must be prioritised in Brexit talks. For medicines the detail of Brexit matters. To ensure uninterrupted continued supply we need rapid clarity on the legal position of medicines during the transition period from the EU and UK. In addition, we need progress from both sides on how the desired close co-operation for the future will work in practice.”

Ben Hargreaves

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