Between now and the end of the Brexit transition period in December 2020, the UK will prepare for its future relationship with the EU. The process will impact patients’ access to medicines and medical technologies in the UK.
Ongoing future relationship negotiations between the UK and EU have the potential to shape what the future will look like from the point of view of trade with the EU, the UK as a market for new products and location for clinical trials, and management of the safety of products made available in the UK.
The Brexit transition period
During the Brexit transition period, the regulation of medicines and medical technologies in the UK continues to be managed by EU-wide systems, facilitating patient safety, access and trade under the single market.
After decades of cooperation across the complex regulatory systems that facilitate trade, supply chains and manage safety of products, there has been substantial growth in frictionless trade between the UK and EU. For medicines, 45 million patient packs go to the EU from the UK every month, and products are often developed in complex supply chains from across Europe.
The most recent government position is set out in the UK’s Approach to Negotiations publication from February 2020. This proposes an approach to defining the future relationship which prioritises the agreement of a deal over no deal, and advocates for tariff and quota free trade. Although it suggests measures that reduce unnecessary barriers to trade, streamline practical processes and provide for appropriate regulatory cooperation, it is also clear that the UK will maintain its own rules and regulations.
Agreeing to treaty-based rules tying the UK to future regulatory alignment to the EU and jurisdiction of the European Court of Justice is a red line for the UK Government, but also the UK has no intention to “diverge for the sake of divergence” and it does not envisage any diminution of the current high standards.
Brexit Health Alliance
The Brexit Health Alliance believes that the UK’s approach to the negotiations should provide patients and industry with as much clarity as early as possible, and prioritise:
Guaranteeing patients uninterrupted supply of their current treatments and fast access to new medicines and medical devices;
- Safeguarding high regulatory standards and public health protections for medicines and medical devices used to treat patients; and
- Promoting the UK’s position as a global leader in life sciences innovation and international influence.
Therefore, the Brexit Health Alliance is calling for the UK government to agree with the EU:
- The maximum possible regulatory and customs cooperation for medicines and healthcare products.
- Patient safety and public health to be guaranteed by close cooperation and making UK regulation as compatible as possible with that of the EU for medicines and medical devices.
- Maximum possible cooperation with the European regulatory network and collaboration with the European Medicines Agency; and UK participation in EU systems such as data sharing networks, pharmacovigilance and new clinical trials infrastructures.
- Active participation in future European-wide vigilance processes for medical devices to better understand post-marketing safety and performance.