The Brexit Health Alliance believes the UK’s plans to leave the EU and the EU’s single market could have serious implications for patients’ access to medicines. This article will explore how UK and EU citizens could be affected by the disruption in trade that could result from the UK’s exit from the EU. Let us start by first looking at how EU regulation of medicines has benefited patients. The primary benefit of a harmonised EU regulation for medicines is that patients are guaranteed a high level of safety. All medicines and medical products on the EU market must be of a high standard, and most importantly, proven to be safe and efficacious before they can be placed on the market in the EU. This means that almost 500 million people in the EU benefit from these high standards, while also encouraging companies to research and develop medicines in the EU. The EU has also developed robust mechanisms for continued surveillance of products already on the market to ensure that they are safe. Patients benefit when countries can work together to map out adverse events, as it is easier to define trends and problems with more data and larger populations. Shared regulatory frameworks at EU level have, of course, also been crucial in providing patients with faster access to treatments. In the global market, separate national systems of regulation of health technologies can slow down access to new treatments for patients. This applies particularly to smaller patient groups which is why regulatory oversight across the EU brings particular added value for children and rare disease patients. So, what is at risk if no solution for medicines and medical devices is found during the Article 50 negotiations? The Brexit Health Alliance is seriously concerned that certain medicines and medical technologies may be delayed in reaching patients or may even become unavailable to patients if no solution for medicines and medical devices is found during the Brexit negotiations. Access to new medicines There could be additional delays for UK patients in accessing new medicines, as the experience of Switzerland, which is not a member of the EU regulatory system, shows. Despite having a number of bilateral trade agreements with the EU, it is estimated that Switzerland gains access to new medicines on average 157 days later than the EU. In Australia and Canada, new medicines come to market on average six to 12 months later than in the EU or US. The EMA currently represents 25% of the global pharmaceutical sales market, compared to the UK’s 3% share. Additionally, a recent report by the Office of Health Economics (OHE) outlines the potential for delay in submissions of new marketing authorisations after the UK leaves the EU. The report states that, depending on the final outcome of the negotiations, the potential impact on the UK means: ● The average lag of submission could be 2-3 months ● 5-15% of applications could be submitted more than a year after the EU27/EEA submission ● Some products may never be marketed in the UK: 45% of applications had not been submitted to any of the three reference countries (Australia, Canada, and Switzerland) following submission to the EMA at the time of the OHE analysis Supplies of medicines across Europe Decades of cooperation and harmonisation of standards on medicines have led to the growth in frictionless trade and supply of goods and products across the EU’s single market and customs union. The scale of trade between the UK and the EU is substantial, delivering medicines to patients in the UK and EU. Forty-five million patient packs go to the EU from the UK every month, and 37 million patient packs go from the EU to the UK. Products are often developed in complex supply chains from across Europe, so there is no such thing as a ‘UK medicine’ – it will have been manufactured, tested, labelled across a number of EU borders. As a result of the relocation of the European Medicines Agency (EMA) to Amsterdam, the agency has already had to de-prioritise certain activities. While expertise will be developed over time, the loss of the UK’s national competent authority, the MHRA, to the joint pool of expertise available under the EMA could be detrimental to the scientific approval of medicines for the EU market in the interim. In 2016, the MHRA led 20% of scientific evaluations of new medicines for the EMA. This means the entire European market could be impacted. Marketing authorisations for medicines held by a UK company will no longer be valid to legally supply medicines into the EU post-March 2019 and vice versa, unless this is specifically agreed upon in the Brexit negotiations. There are currently approximately 2,400 licences or around 361 products (37%) for which the centrally marketing authorisation procedure is held by UK-based companies. These licences will need to be reviewed in order for the products to be made available to EU patients in case a system of mutual recognition is not agreed between the UK and the EU in this area. Conversely, where licences are held in the EU, there will be potential disruption in the UK. This means that a solution will have to be found for the approval of 978 medicines on the UK market that have received marketing authorisation via the centralised European procedure since 1995. But what is the Brexit Health Alliance calling for? Our priority is that there should be no negative impact on patients. For this to be achieved it is crucial for the issue for future cooperation on medicines to be prioritised in the negotiations, so that patients and the wider public are not negatively impacted from disruptions in the supply of medicines and other health technologies, or from a reduction in standards or safety. Patient safety can be guaranteed post-Brexit if there is continued alignment in the UK as much as possible with the EU’s regulation of medicines and, if the close regulatory cooperation between the EU and UK as proposed by the UK government, is achieved during the negotiations. It will be key to find pragmatic solutions for allowing patients and the public to benefit from the UK’s participation in EU systems such as data sharing networks, pharmacovigilance and the new clinical trials infrastructures post-Brexit. What is critically needed is an implementation period beyond March 2019 which should adequately reflect the time needed to ensure relevant customs, trade and regulatory procedures are in place. More Information On Pharmafile