European Union (Withdrawal) Bill

Debate between Baroness Goldie and Lord Kakkar

Committee: 6th sitting (Hansard): House of Lords
Monday 12th March 2018 Lords Chamber

[Baroness Goldie]

The problem is that the Bill is intended to transfer a body of law from A to B. At the moment, this regulation is incomplete: it has not been enacted and it is not currently in the body of EU law. That is why there is a risk that it will not be covered under this Bill.

[Lord Kakkar]

I wonder whether the noble Baroness will take this slightly different point. If, as is argued, the clinical trials regulation will not form part of the applied European law at the time of exit, clinical trials will still have to be conducted under some form of law in our country, and that will be the 2004 directive that currently applies. If that goes forward, what ultimately will happen is that everything we know that is wrong with that directive, and which has been corrected by the new regulations, will apply in our own country. Even if we continue to be active participants in clinical research, we will be so under the less satisfactory situation of the current 2004 directive unless the Government decide to modify that directive. As there must be a legal basis for undertaking clinical research, does it not seem logical simply to apply what we have already agreed is a sensible approach rather than having to reinvent a new basis for legal provision to undertake clinical trials in our country?

[Baroness Goldie]

I partly agree with what the noble Lord is saying because if this regulation has not become law before we leave, we can use Clause 7 of the Bill to attend to deficiencies, amend or correct, and that is what we will do to keep our own regime of law up to date. However, at this point it is impossible for the Government to go further than that and embrace matters which are potentially directly enactable under this new regulation and involve the EU, which implies that you have to be a member of the EU and a part of the agency. We have a strong desire to see that kind of partnership continue, but it can only continue if it is successfully negotiated.

[Lord Kakkar]

Does not the Minister consider there to be a substantial risk? As I understand it, non-member states of the European Union are obliged to be fully compliant with the 2004 clinical trials directive. If we become non-members of the European Union and do not have an agreement in this area prior to leaving, will we not be forced to continue under the 2004 directive if we wish to participate in the data and information generated from clinical research being applicable more broadly for those who wish to take their arguments for adoption of those findings, and authorisation of new medicinal products as a result of those findings, in the European Union?

[Baroness Goldie]

My noble friend Lord O’Shaughnessy, who is advising me, says that once there is a new regime in Europe, all non-member states will have to make a decision about whether or not to be compliant with that. We hope that in our Brexit negotiations we have made clear—the Prime Minister has emphasised this—the huge importance we attach to these issues. They are massively important and we want to get a positive outcome in the negotiations, but it would be premature at this stage to incorporate into this Bill the anticipated enactment of the new regulation because it might be inert law.