Windsor Framework - The Start of a Brighter EU-UK Life Sciences Future?

A Cooling of Relations

The Medicines and Healthcare products Regulatory Agency (the MHRA) was once looked upon as the leading national regulator within the European regulatory framework. The European Medicines Agency (the EMA), which is the EU-wide medicines regulator and with whom the MHRA worked closely, was based in Canary Wharf. Then the Brexit vote happened. The EMA moved to Amsterdam. The people on the ground may have wanted something different, but political pressure meant that a once very close relationship between the regulators cooled considerably.

Things worsened as accusations mounted on each side of the political fence through the divorce period. Then eventually, Boris Johnson 'got Brexit done'. There were threats of no deal between the EU and the UK, but then finally, on Christmas Eve 2020, the parties signed the Trade and Cooperation Agreement. A deal. At over 1,200 pages, there was a lot in it. But there was a lot that was not in it. One such sector noticing that was pharma and life sciences.

The Trade and Cooperation Agreement

The good news was that pharma products or medical devices imported or exported between the UK and EU were tariff and quota free. The Agreement also covered good manufacturing practice and the mutual recognition of inspections by the national regulators.

Not in the agreement but what later followed was the approval of each other's data protection regimes for data export.

However, the big gaps included the following:

• No mutual exhaustion of rights regime. The UK continued to allow products put on the market in the EEA to come into the UK, because any intellectual property rights were deemed to have been 'exhausted' as soon as they were put on the market anywhere in the UK or EEA; however, products going the other way did not have that effect, thus stopping the parallel export of products from the UK into the EEA.
• No mutual regulatory authority recognition or equivalence.
• No mutual recognition of batch testing, meaning that products had to be tested again when entering into the EEA even if they had been tested by a Qualified Person in the UK already.
• No mutual recognition of good clinical practice.
• Information sharing and packaging, labelling and other aspects of regulations on falsified medicines. Great Britain is no longer a part of the EU's Falsified Medicines Directive regime.

With a growing gulf between the MHRA and other regulators in the EU, things have since worsened for pharma and life sciences businesses.

The Northern Ireland Protocol

Then there was the thorny problem of Northern Ireland. How do you deal with the issue of having a land border between the UK and EU but without a hard border on the island of Ireland? The two sides had come up with a fudge called the Northern Ireland Protocol. In essence, this had a combination of rules that meant that Northern Ireland remained in the EU's Customs Union and Single Market, but also part of the UK. Nevertheless, it was far from perfect, and there was confusion over the roles of the MHRA and the EMA over medicines in Northern Ireland. Medicines and other products were treated differently when supplied in Northern Ireland compared to other parts of the UK. So, instead of people in Northern Ireland having the best of both worlds - being part of the UK and the EU's Single Market and Customs Union - the territory was getting a raw deal. In particular, many medicines were not being supplied. There were other tensions in other sectors.

Something had to be done in order to help the people of Northern Ireland.

As personnel on the political sides changed, and with a thawing of the iciness, the parties have now agreed the Windsor Framework.

What's in the Windsor Framework?

Here are the highlights:

• Patients in Northern Ireland will now receive the same medicines in the same packs with the same labels as in the rest of the UK.
• The MHRA will approve all medicines that are on the market in Northern Ireland.
• There will not be any EU Falsified Medicines Directive packaging, labelling and barcode requirements for medicines in the territory.
• Medicines going from Great Britain to Northern Ireland will travel through a new Green Lane, meaning goods that remain in the UK and not going beyond Northern Ireland into the Republic of Ireland will not have additional paperwork, checks and duties.
• Any medicines or other products that are produced in Northern Ireland will still have frictionless access to the EU market.

A New Dawn?

The Trade and Cooperation Agreement was entered into against the odds in 2020. However, there were lots of gaps and it was a thin deal in many areas. The Brexit divorce process had led to a lot of bitterness. What has followed with the concessions by the EU side in the Windsor Framework would have been unthinkable until recently. And there was no masking the warmth between the politicians on the UK and EU side when signing the Windsor Framework. With this warmth, the pharma and life sciences sector must surely be looking more optimistically to the future, with the opportunities for trade, closer co-operation between regulators and with businesses, investment and funding. With political differences having driven a wedge between people who had just wanted to get on with people they had worked with in the sector, could this Agreement that eases tensions around Northern Ireland signal the outbreak of a closer relationship more widely once again - for the good of life sciences regulators, businesses and ultimately patients?

If you have any thoughts on this development, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 07795 570 072, or complete the form below.