The European commission has delivered on its promise to ensure continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta.
How has the EC delivered on its promise to ensure continuous supply of medicines to NI, Cyprus, Ireland and Malta?
The Commission has delivered on its promise by putting forward a proposal to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address outstanding supply concerns in Cyprus, Ireland and Malta.
What does this mean in the context of the Northern Ireland Protocol?
With the proposal, the Commission is delivering on its intention to facilitate the implementation of the Protocol on Ireland/Northern Ireland on the ground, in line with the package of far-reaching solutions for Northern Ireland tabled on 13 October 2021.
In the context of the Protocol on Ireland/Northern Ireland, this means that the same medicines will continue to be available in Northern Ireland at the same time as in the rest of the United Kingdom, while specific conditions ensure that UK-authorised medicines do not enter the Single Market.
About the proposal
The EU will amend its own legislation on medicines to ensure the following:
- Generic medicines – Generic medicines (such as paracetamol) can be authorised under national UK procedures, in compliance with EU rules on medicines. People in Northern Ireland will have access to these medicines at the same time as people in the rest of the UK. Pharmaceutical companies will have the option of choosing either the UK authorisation process or an EU Member State procedure. If companies opt for the UK national procedure, the UK regulator will not have to agree the terms of the authorisation with Member State authorities and will be solely in charge.
- Access to innovative medicines via a bridging solution – People in Northern Ireland will also have access to innovative life-saving medicines (including new cancer medicines) at the same time as any other person in the UK. A ‘bridging solution’ will allow any new medicine authorised in the UK to be supplied to Northern Ireland, until the relevant authorisation is also given in the EU. Those temporary authorisations should be time limited and cease once a decision on the medicinal product is taken at EU level. This ‘bridging solution’ is in addition to the existing compassionate and emergency use mechanisms under EU law.
- Regulatory functions – All regulatory functions can remain in the UK if they are currently located there. This means that there is no need to relocate any regulatory functions or testing facilities from Great Britain to Northern Ireland.
- Batch testing – For medicines brought into Northern Ireland from the rest of the UK, batch testing does not need to be repeated if it has already been carried out in Great Britain or the EU.
- Manufacturing or import authorisation – No manufacturing authorisation or import licenses are needed for medicines supplied from Great Britain to Northern Ireland, subject to certain conditions.
- Packaging and leaflet – Authorisation by the UK regulator can allow companies located in Great Britain to use a single pack and leaflet when supplying markets in Great Britain and Northern Ireland. There would be no need for separate packaging.
- Certain derogations for Malta, Cyprus and Ireland – These three countries will benefit from certain derogations for a three-year period. For example, during this period in these three countries, importers of medicines from the UK will not need to hold manufacturing authorisations, nor will these medicines need to be batch tested again if they have already been tested in the UK. This will give operators more time to adapt. Work on a long-term permanent solution is ongoing in the context of the EU’s Pharmaceutical Strategy.
Does the proposal from the EC also require the UK to respect certain conditions?
Yes it does.
- Packaging requirements – The proposal provides for packaging requirements to ensure that UK-authorised medicines do not enter the Single Market.
- Responsibility for authorisation of medicines in Northern Ireland – The UK assumes sole responsibility for authorising medicines for Northern Ireland. This is contingent on the UK complying substantively with EU law on quality, safety and efficacy of human medicines when issuing market authorisations for Northern Ireland. This reduces risks for the EU Single Market.
What are the next steps?
The next steps are:
- the legislative proposals will be sent to the European Parliament and the Council as soon as all linguistic versions are available.
- In order to ensure stability and predictability, there will be an extension of the Commission’s interpretive note to ensure a continuation of the supply of medicines to Northern Ireland as well as Cyprus, Ireland and Malta. Existing arrangements will therefore continue. This will last until the end of 2022 unless the legislative procedure is finalised sooner.
Where can you find further information on the EC proposal?
Further information on the Commission proposal is available in this Q & A.
Source: Europa website