DDA Board advisor Baroness McIntosh of Pickering has raised the challenge of the falsified medicines directive (FMD) in a house of Lords debate on the effect of Brexit on health and welfare in the UK.
Speaking on behalf of dispensing contractors, she told health minister Lord O’Shaughnessy of the “huge cost implications, particularly for general practice” of the FMD. She also warned: “As I speak there is no clear guidance as to what the IT provisions will be. There is obviously a question mark over who will pay. I hope that the Minister will take the opportunity to explain today to what extent we will apply the falsified medicines directive.”
Lord O’Shaughnessy told the Baroness: “We are pushing ahead with the implementation of the falsified medicines directive… I met SecureMed, the body implementing it, yesterday.”
Liberal democrat peer Baroness Thomas of Winchester also asked the minister for reassurance that the UK would not find itself “behind the EU in the queue for approval of new treatments” if it did not play any part in EMA processes. She told the minister: “As a result of Brexit, the influence the UK will have on the EMA will be significantly diminished compared with the role which the Medicines and Healthcare products Regulatory Agency currently plays within the EMA. Negotiations should try to secure the quickest access to treatments for UK patients.”
Lord O’Shaughnessy replied: “We will continue to play a role in the EMA during the implementation period to make sure that there is no interruption to supplies. We will support the transition of the EMA to Amsterdam. Some specific details still need to be worked out about membership of the committee, rapporteur rights and so on during that period. The noble Baroness is right, they will be less than we have at the moment, but their exact nature needs to be determined.”