Delay Means New EU Clinical Trial Rules May Not Be Transferred To UK
Executive Summary
With the implementation of the EU Clinical Trials Regulation now postponed to the second half of 2019, it is unlikely that its provisions will be taken over into UK legislation as part of the Brexit “Repeal Bill” that will convert all EU laws and regulations into domestic UK law.
The implementation of the EU Clinical Trial Regulation has been postponed to the second half of 2019, meaning that its provisions are unlikely to be included in the European Union (Withdrawal) Bill, which is intended to copy all existing EU legislation into UK domestic law, repeal the 1972 European Communities Act, and put an end to the jurisdiction of the Court of Justice of the EU in the UK as a result of the Brexit vote.
The CTR is a long-awaited key piece of legislation for stakeholders such as regulators, industry, patients and CROs in Europe. Among other things it will harmonize the assessment and supervision procedures for clinical trials across the EU via a single application portal and trials database that will be run by the European Medicines Agency. It is also expected to bring greater transparency of trial data and higher safety standards for trial participants.
But while the CTR itself is legally in force, its provisions will not apply until six months after its accompanying portal and database system has been confirmed to be fully functional. It was announced recently that the system’s go-live date had been delayed and so the CTR provisions would not apply until 2019, rather than 2018 as had earlier been expected.
Following the October meeting of its management board, the European Medicines Agency has now confirmed that the CTR will not apply until “the second half of 2019.” Given that the UK is due to leave the EU on March 29, 2019, the question arises whether the provisions of the CTR can be implemented in the UK via the “Repeal Bill”, as it is informally known.
To try to get some clarity on this, Norman Lamb, the chair of the House of Commons Science and Technology Committee, wrote to Robin Walker, parliamentary undersecretary of state at the Department for Exiting the EU, asking whether the CTR would be covered by the Repeal Bill.
In response, Walker said that under the Repeal Bill, all EU law – including regulations, directly effective decisions and tertiary legislation – will be converted into UK domestic law after the Brexit date “so far as operative immediately before exit day.” Regulations, he said in a Sept. 21 letter to Lamb, would be operative where they are in force immediately before Brexit, “except where they are stated to apply after the date on which they come into force.”
“Our future alignment with the new EU Clinical Trials Regulation will be subject to negotiations” – Robin Walker, DExEU
He said the government was aware that the date of application of the CTR had been postponed and that now it “may take effect after we leave the EU”. This meant, he said, that its provisions “will not be covered by the Repeal Bill and so our future alignment with the new EU Clinical Trials Regulation will be subject to negotiations.”
He stated that the UK was nonetheless “fully committed to continuing the close working relationship we enjoy with our European partners across the field of medicines regulation that will include any future regime on clinical trials.”
The exact nature of the future relationship between the UK and the EU is, of course, far from certain, with the Brexit negotiations in deadlock and UK ministers at odds over whether the government should go for a “soft” Brexit that includes continued membership of the single market and customs union or, as some are pressing for, countenance a “no-deal” outcome.
Companies And Regulators To Give Evidence
Whether the UK and the EU will be able to strike some sort of deal to keep drug regulations in alignment after Brexit is a key issue for regulators and the industry, and is on the agenda of an evidence session being held by the UK House of Lords Science and Technology Committee today (Oct. 17).
At the session, entitled “How will the life sciences strategy affect businesses,” Ian Hudson, chief executive of the Medicines and Healthcare Products Regulatory Agency, and Sir Andrew Dillon, chief executive of the National Institute for Health and Care Excellence (NICE), will be asked for their views on the “possible impact different regulations between the UK and the EU could have after Brexit” and whether regulators should do more to aid the uptake of innovative products by the NHS.
Dave Allen, senior vice-president, respiratory disease R&D, at GlaxoSmithKline, and Mene Pangalos, executive vice-president of the innovative medicines and early development (IMED) Biotech Unit at AstraZeneca, will be grilled on the contribution that large pharmaceutical companies can make to the implementation of the UK life science strategy and the attractiveness of the UK as place for businesses to invest in life sciences.
Representatives of three life science SMEs, Randox Laboratories, Inhealthcare and Matoke Holdings, will discuss the challenges faced by smaller companies in areas such as funding and innovation.
Implications For EU Research Funding
Lamb had also asked Walker about the EU’s Horizon 2020 research program. Noting that the government had previously said that EU funding awarded before, but extending beyond, Brexit would be underwritten by the Treasury, he said it was not clear whether UK researchers should “invest time in submitting bids where the award is likely to be made after that point.”
“Universities and other institutions have made clear that they need to know now whether they should be preparing bids, so there is an urgency that the Government clarifies the position on Horizon 2020 and participation in the successor programmes,” Lamb wrote.
In response, Walker said that the UK would “work with the [European] Commission to ensure payments when funds are awarded, and Horizon 2020 participants should continue to collaborate as normal. This includes cases where bids are submitted before our withdrawal, but approved after our withdrawal.”
He added that the EU had “strong collaborative relationships with a range of international partners in science and innovation, underpinned by bilateral agreements, for example with the US, Canada, lsrael and the EFTA countries.” As part of the “new, deep and special partnership” with the EU, he said, the UK would “seek an ambitious science and innovation agreement with the EU that ensure the valuable research links between us continue to grow.”
From the editors of Scrip Regulatory Affairs.