Today's adoption follows last week's positive vote in the European Parliament. The proposals were put forward by the Commission last December, following its extensive engagement with citizens, industry and other business representatives in the EU and the UK, in addition to extensive talks with the UK government to find this long-lasting solution.
Welcoming this adoption, Vice-President Šefčovič said: “During my visit to Northern Ireland last autumn, I promised to do whatever it takes to ensure the continued supply of medicines to Northern Ireland. We now have a lasting solution, which was delivered in record time. I will continue to work closely with the UK government to ensure predictability, legal certainty, and the prosperity of all communities in Northern Ireland.”
Commissioner for Health and Food Safety, Stella Kyriakides, said: “The continuous supply of medicines is essential for hundreds of thousands of patients in Northern Ireland - as well as Cyprus, Ireland and Malta, whose markets are historically dependent on medicines from the UK. We have now fulfilled our commitment to find a solution to ensure that all citizens can continue to get the medicines they need, at all times. I welcome this swift agreement by the European Parliament and Council.”
The COVID-19 pandemic has shown that having strong supply chains and access to medicines at all times, so that health systems operate seamlessly, is of paramount importance.
Next steps for Cyprus, Ireland and Malta:
For Cyprus, Ireland and Malta, the rules endorsed by the European Parliament and the Council provide a temporary derogation so that they can continue to source medicines from the United Kingdom only if needed. The Directive and Regulation apply retroactively from 1 January 2022 and 31 January 2022 respectively. It is expected that within three years, until 31 December 2024, these markets will gradually phase out the temporary derogations and decrease the dependency of their domestic markets on the supply with medicinal products from or through parts of the United Kingdom other than Northern Ireland.
In addition, at the end of this year, the Commission will make proposals to revise the EU's pharmaceutical legislation. These proposals will seek to provide longer-term structural solutions, in particular, to the issue of access to medicines, with special attention to enhancing security of supply and addressing risks of shortages in the smaller markets of the Union.
Today's solution is part of the Commission's package of far-reaching measures proposed in October 2021 to respond to the difficulties that people in Northern Ireland have been experiencing because of Brexit.
More information on the new rules:
- Publication date
- 12 April 2022
- Representation in Ireland