Oireachtas Joint and Select Committees

Wednesday, 30 January 2019

Joint Oireachtas Committee on Health

Implications for Health Sector of United Kingdom's Withdrawal from the EU: Discussion (Resumed)

Ms Rita Purcell:

We recognised very early that for commercial reasons it is very important for companies to treat Ireland and the UK as a common market and joint labels underpinned this for many years. Having looked at the issue, we have publicly stated since Article 50 was invoked that provided the labels continued to meet the requirements of the EU directive, we will continue to accept UK-Ireland joint labels. That position was slightly at odds with advice the Commission had given, and we have been lobbying very strongly on that. I am very pleased that, as of last Wednesday, the Commission has accepted the Irish position. Provided those labels remain within regulatory convergence, we will be able to accept UK label information on Irish packs. We will continue to see Irish-UK labels.

Will there be regulatory divergence to address that risk? The UK has stated strongly that it will continue to apply EU regulations in the foreseeable future. Given that the UK will become a small market in terms of the EU - with 60 million people as opposed to 600 million - there is a strong incentive, certainly for all the international or global products, to remain largely convergent. We have also spoken with both the human and veterinary product regulators in the UK and their current position is that they will work with us to ensure we can keep that alignment in place. We do not know if that will continue five years down the road but in the next number of years there is a good grounding to continue having shared labels and leaflets. I hope they can continue to make the Irish market more attractive commercially to pharmaceutical companies.