Pharmaceutical industry products are in the list of top five products that are most imported and exported from the UK to the EU and vice versa.
Brexit can have several implications of Europe’s pharmaceutical industry. From product development to market approval to the shipping of medicines and medical devices, pharmaceutical companies can expect to be affected in a broad range of areas. Companies in the pharmaceutical industry in the UK will have to manage the impact of Brexit carefully to prevent some of the negative aspects. However, uncertainty will have adverse effects on pharmaceutical and life sciences companies in other European countries as well. Experts at Infiniti predict how Brexit will affect life science and pharmaceutical industry.
Relocating European Medicines Agency (EMA)
One of the key pharmaceutical industry market access challenges that Brexit brings along with it, irrespective of the path it takes is related to the future location of the European medicines agency. Since its inception in 1995, EMA had been located in London. However, the Netherlands has now won the bid to host new EMA headquarters post-Brexit. With the EMA headquarters soon moving to Amsterdam, they may implement several changes to rules for medicinal products that are developed and tested in the UK. However, the extent of Brexit-induced changes to the pharmaceutical industry has yet to be decided.
Movement of people and pharma products
Pharma products form a considerable part of goods that are exported to and from the UK. Any post-Brexit hurdles to the free movement of goods could mean trouble for those supplies, potentially leading to temporary drug shortages. This is especially true in the case of drugs such as medicinal insulin that are not manufactured in the UK nor is it easily stored, as it requires temperature-controlled conditions. In order to reduce the risk of drug shortages in the case of a no-deal Brexit, the British government has asked pharmaceutical companies to add a minimum of six weeks’ worth of additional backup supply of medicines to their usual buffer stocks by the exit date, and to ensure that contingency plans were in place for drugs with shorter shelf lives. However, it is not only the movement of medicines that’s at risk. As the possibility of stricter rules regarding the flow of people between the UK and the EU looms, companies in the pharmaceutical industry are concerned about their ability to attract talent from outside Britain in the future. It is vital that pharmaceutical companies to still be able to access the best talent from around the world.
Change in the UK’s contribution to drug regulation
UK plays a major role in drug regulation in the EU through the work of the Medicines and Healthcare Products Regulatory Agency (MHRA). The UK frequently serves as rapporteur/co-rapporteur in the EU’s centralized procedure and as the reference member state in the decentralized procedure. It will prove to be a challenging task to replace the MHRA’s capacity and expertise, particularly if the timetable for reform is aggressive.
Safe supply of blood and organs
Another pressing challenge faced by companies in the pharmaceutical industry due to Brexit is linked to ensuring blood and blood products are safe. If there is a no-deal Brexit, the EU Blood Directives will not apply to the UK and it will be considered a third country by the EU regarding sharing blood, blood components, and information. The UK Government has declared that in the event of a no-deal, the current blood safety and quality standards for blood and blood components will remain the same, and therefore adhere to EU standards, allowing them to be imported into the EU. Similarly, the UK Government has laid out its provisions for ensuring the supply, as well as the safety and quality, of organs, tissues, and cells in the event of a no-deal. The UK would no longer be part of the EU Organ and EU Tissues and Cells directives, however, relevant UK establishments, such as stem cell laboratories and fertility clinics, would be required to work to the same standards. These organizations would need to individually agree on import and export of the products with EU and EEA authorities and establishments.