The recent decision of the UK to leave the EU could lead to a dearth of life-saving medicines and in turn delay the timely access to healthcare to millions of people in the UK and Europe. Two of the top ten global pharma companies are from the UK, namely, GlaxoSmithKline and AstraZeneca. Neither of them were in support of Brexit, as the exit is popularly referred to colloquially. Brexit can have severe implications on healthcare access as the price of medicines is directly linked to the value of the GBP, which has fallen to a record low in the recent times due to the Brexit decision. Until there is a clear resolution on how the UK and the EU deal with the withdrawal, as per the Article 50 of the Lisbon Treaty, the burden on the National Health Service (NHS) for affordability will increase for these life-saving medicines.
The funding to NHS is another important factor contributing to the healthcare access. If the UK redirects the whole amount spent to maintain its EU membership (~£150 million a week), access to innovative medicines will be even better. However, this is highly disputed. Post-Brexit, the healthcare budget would shrink to as much as £135 per capita by 2020 as per the predictions of the Economic Intelligence Unit. The healthcare companies will have to restructure their funds allocation as well as realign on organizational aspects. This could mean delay in clinical trials and in turn, delay in the access to innovative, life-saving medicines. Patients ‘access to important EU initiatives like the Horizon 2020 science programme, the European Cancer Patient’s Bill of Rights, European network for Health Technology Assessment (EUnetHTA) and the like could be deferred. A considerable portion of the health workforce of the UK is from different parts of the EU. Post-Brexit, turmoil could bring in an uncertainty around how the relationships of the health workforce would stand as it is a major contributor to healthcare access.
The EMA, currently based in London, could be relocated to another location. This could bring delays in access due to the possible loss of a centralised procedure for Marketing Authorizations (MA) and the return to country-specific regulations. It will be further accompanied by the higher prices for medicines, due to delayed market entry and manufacturers trying to make up for the lost time in the market. All these factors will cause the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK to quickly devise a national authorisation for new products. The EU clinical trials regulation 536/2014 allows a single application across the EU, reducing the administrative burdens for the applicants. Post-Brexit if the UK decides not be a part of even the European Economic Area (EEA), there could be an extra burden on companies planning to conduct multi-centre trials in the UK and the EU, as separate procedures need to be followed. The CE mark would no longer be an imperative entity to market medical devices in the UK. More importantly, the UK’s reputation, known for its influence on the Committee for Medicinal Products for Human Use (CHMP) and concepts developed by its experts for clinical trials, could be under potential threat.
However, the UK might already have devised strategies to address these access related issues:
– Considering the Switzerland regulatory model, which is not a member of the EU or the EEA, and where the EU MAs are accepted, the UK can stay aligned post-Brexit
– The NHS could adopt an outcomes-based model of care and more of IT infrastructure to deliver efficient care and offset the shortage in workforce
– Manufacturers in the UK could continue to export medicines, as long as the regulatory framework remains equivalent
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