Ladies and gentlemen,
Today, we are announcing good news for EU patients in Cyprus, Malta and Ireland, as well as those from Northern Ireland, who feared that access to their medicines could be impacted due to the UK's decision to withdraw from the EU.
I would like to thank to Vice-President Šefčovič for his commitment to finding a solution. I would also like to thank our colleagues in the Commission services who have been working hard over many months to find creative and safe solutions to address the important issue of medicines supply.
The exceptional nature of these proposals must be seen as a further sign of the Commission's commitment to the full and effective implementation of the Protocol for Ireland and Northern Ireland.
Let me start by saying that our aim was clear from the start.
We worked to bring concrete solutions to concrete challenges. Challenges linked to Brexit.
Our priority was clear: patients' access to medicines shall never be put at risk!
This is even more important today in view of the challenges for the health care sector in this pandemic period. The past two years have shown how important it is to have strong supply chains and access to medicines at all times, including to ensure the continuation of routine health care services.
This is what we are doing today. Ensuring that people in Northern Ireland and in Cyprus, Malta and Ireland, that still depend on the UK medicines supply, can continue to get the medicines they need whenever they need them.
To guarantee long-term continuous supply of medicines from the UK, our proposals make targeted amendments to the EU pharmaceutical legislation, as well as targeted changes to our clinical trials rules.
They give exceptional administrative flexibility to the UK in respect to Northern Ireland so that certain regulatory functions for medicines for human use authorised by the United Kingdom for the Northern Ireland market under the Protocol may exceptionally be located in Great Britain.
This covers for example marketing authorisation holders and qualified persons for pharmacovigilance and batch testing.
This is important for Northern Irish patients since they will have access to innovative life-saving medicines, such as new cancer medicines, as soon as other patients anywhere else in the UK.
If a new medicine has been authorised in the UK, but not yet in the EU, it will be temporarily supplied to patients in Northern Ireland pending authorisation in the EU.
Those temporary authorisations should be time limited and end as soon as the Commission has granted the authorisation to market the medicine.
It is important to recall, that patients in Northern Ireland already have immediate access to EU authorised medicines thanks to the Protocol.
For Cyprus, Malta and Ireland, our proposal provides a temporary derogation so that they can continue to source medicines from the UK if needed.
A longer-term and structural solution to the issues of access to medicines for Malta, Cyprus and Ireland is also part of our ongoing full review and revision of the EU's pharmaceutical legislation.
I want to remind you that our proposal to revise the pharmaceutical legislation is expected in a year from now, at the end of 2022.
To protect the internal market, medicines nationally authorised by the UK for the Northern Ireland market will not be distributed to the rest of the EU Internal Market.
We have done our job, in finding a viable and pragmatic solution under the Protocol.
Until these new amendments to the legislation are effectively in place, existing flexibilities will continue to apply.
There will be an extension of the grace period to ensure a continuation of the supply of medicines in Northern Ireland, as well as Cyprus, Malta and Ireland.
This will normally last until the end of 2022, unless the legislative procedure for our proposals on medicinal products for human use is finalised prior to that.
Therefore, we call today on the Council and the European Parliament to swiftly adopt our proposals.
Patients' interests are at the centre of all our policies and choices. This is the case today as well.
I thank you for your attention.