Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA), said: “We are currently seeing major challenges to supplying medicines to Northern Ireland patients. This situation is caused by the significant increase in regulatory burden and complexity from Brexit and the Northern Ireland Protocol’s interpretation. We are already seeing some medicines become unavailable and are also aware of companies not planning to launch future medicines due to being caught between two regulatory systems. Without action now, this will potentially significantly reduce patient choice and medicines availability.
“This problem stems from the interpretation of the Northern Ireland Protocol. Before Brexit, under the EU regulatory system, a medicine could be supplied to many European countries in compliance with one regulatory dossier, a single set of standards and regulations with no need for duplicate regulation in individual countries. It happens through something called a Decentralised Procedure or DCP, which is the licensing route for most generic medicines on the market. The generics industry delivers high volumes of medicines at low prices and with small commercial margins. It thrives on simplicity and efficiency but is now caught in a complicated situation with Northern Ireland – which under the Protocol is treated as part of the EU – requiring different medicines regulation rules to the rest of Great Britain. This situation threatens to prevent companies from supplying an identical product to Great Britain and Northern Ireland. The result of this duplication would be to require extra warehousing, laboratory testing and technical specialists. This duplication could make supplying Northern Ireland in many cases unviable in the longer term.
“A fundamental rule of the EU regulatory system controlled by the European Commission is that many roles, activities, and responsibilities must be physically located within the EU. Companies are finding themselves under intense and increasing pressure from EU regulators to remove all activities in Great Britain as soon as possible. These include quality control and safety monitoring experts who are responsible for releasing each batch of medicines onto the market. The result is that Northern Ireland-bound products cannot be supplied from a GB site under the DCP route. As noted above, it means that the supply chain for these medicines is effectively separated from MHRA-authorised GB-bound medicines for which domestic sites are used in their supply. Moreover, due to the different Protocol interpretations between the EU and UK, companies cannot transfer the Northern Ireland licence under the DCP route to a UK-wide licence, which the MHRA would issue.
“Companies are resisting making these regulatory changes because they would be hard to reverse and put at risk the ongoing supply to patients in Northern Ireland. However, this position, where generic companies are carrying additional burdens, is not sustainable. Indeed, resisting European regulators’ wishes could put at risk companies’ entire ability to supply other markets in the EU.
“Due to the Protocol’s interpretation, the situation has forced our members to review the viability of their ongoing medicines portfolios for Northern Ireland. Without a solution immediately, some manufacturers report that up to 90% of medicines could be at risk of being withdrawn. Northern Ireland risks becoming a small, self-contained market, similar to Malta or Cyprus, that cannot access the wide range of medicines provided in the rest of the United Kingdom.
“Solutions to these issues are complex, but we believe they are possible, especially if medicines licensed for use in Great Britain were also legal in Northern Ireland without the separate regulatory requirements. The use of existing regulatory verification also means medicines would not leak into the EU single market. If such validity were given to all UK and EU licences, it would uphold the Protocol’s intention.
“While UK civil servants are working hard to resolve this problem, we need the European Commission to come together with the Government and create a longer-term political resolution and act now to avoid the real risk to the supply of medicines to Northern Ireland.”