Question to the Department of Health and Social Care:

To ask Her Majesty's Government what steps they are taking to ensure access to rare disease medicines is not delayed after Brexit.

The Government is committed to the safe and effective regulation of medicines in the United Kingdom; ensuring patients and the public have fast access to new, innovative medicines, including medicines for rare diseases.

The future regulatory system for medicines is subject to negotiation. The White Paper proposal sets out a proposed UK-European Union free trade area for goods, to ensure continued frictionless access at the border to each other’s markets, underpinned by an upfront commitment to a common rulebook on goods and a Facilitated Customs Arrangement to avoid customs checks and controls at our borders. A copy of the White Paper The Future Relationship Between the United Kingdom and the European Union is attached.

Furthermore, UK and EU negotiating teams have already agreed a time-limited implementation period, that will maintain access to each other’s markets on current terms - providing certainty for businesses across the EU and UK and time to prepare for the future.

On 22 August the Government also set out its plans for medicines regulation in the unlikely event of no deal, through a technical notice. In the unlikely event of a no-deal scenario, the Medicines and Healthcare products and Regulatory Agency would be a stand-alone medicines regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level.

The Government also launched a consultation on medicines regulation for the event of no deal; this closes on 1 November 2018.

Whatever the exit scenario, we will continue to ensure that UK patients are able to access the best and most innovative medicines and medical devices and that their safety is protected.