News World EU drug regulators step up work to prepare for 'no deal' Brexit

EU drug regulators step up work to prepare for ‘no deal’ Brexit

Drug regulators across Europe are hiring extra staff and increasing their workload as the role of British experts in the EU-wide system of medicines supervision winds down ahead of Brexit.

Although the UK’s exit from the European Union is still eight months away, Britain has already stopped taking on new projects that will extend beyond March 29, 2019 and is preparing to hand over existing drug review work to other countries.

That leaves a major gap, since British experts carry out around a fifth of the work for the centralised European Medicines Agency (EMA), the EU’s equivalent of the U.S. Food and Drug Administration.

In addition, Britain’s Medicines and Healthcare products Regulatory Agency also plays a pivotal role in Europe’s decentralised system of drug supervision, which is based on mutual recognition.

“It’s a real pity that we are going to lose the UK expertise, which is certainly very strong,” said Hugo Hurts, executive director of the Netherlands Medicines Evaluation Board.

“It’s a real challenge, but I’m not going to say there is not enough knowledge to replace that in the rest of the network,” Hurts told Reuters.

Germany, Sweden and the Netherlands are among the other big contributors to the EU drug review process, alongside Britain.

The Dutch agency has already added more than a dozen extra staff, and drug regulators in other EU states are also hiring more people.

In addition, officials are exploring how more drug assessment work can be performed by multinational teams in future, rather than just one agency.

Despite a vote by UK lawmakers this week calling for Britain’s continued participation in the Europe regulatory network for medicines, there is no certainty that any such deal will be reached.

That reflects the wider lack of clarity over Britain’s future relationship with the world’s biggest trading bloc after it leaves the EU next March.

“At the end of the day, the network has to be prepared for the worst-case scenario. If we are not prepared by March 29, 2019 for a ‘no deal’ Brexit then we would have done a very bad job,” Hurts said.

Maintaining timely approvals for new drugs is crucial for pharmaceutical and biotechnology companies, which have dozens of experimental medicines due to be assessed in the next couple of years.

The Brexit-induced disruption also comes at a time when regulators are having to grapple with oversight of a range of new health technologies, such as gene therapy, and a slew of big data on health outcomes.

Global drug companies, including UK-based GlaxoSmithKline and AstraZeneca, have been vocal in calling for continued close EU-UK ties after Brexit. The issue is also important to many Japanese drugmakers that have made Britain their European base.

The EMA itself is being uprooted from London to Amsterdam, increasing the pressure on the system for overseeing drug safety. Although Amsterdam is more attractive than other locations that might have been chosen, the agency is still braced for significant staff departures.

A staff survey last year predicted 19 percent employee losses from the move to Amsterdam, and the EMA’s executive director Guido Rasi said this was based on optimistic assumptions.

Meanwhile, individual drug companies are taking steps to prepare their supply lines in the event of a disorderly or no-deal Brexit that could threaten the smooth flow of products across borders.

AstraZeneca said this week it was increasing stockpiles of those medicines in Britain and Europe that could be affected by around 20 percent.

Top Stories

Access to Troodos controlled by Police

The Police announced that on the basis of the Health Ministry decrees aiming to contain the outbreak of the pandemic, tomorrow Sunday, access to...

129 new cases, four deaths announced on Saturday

The Health Ministry announced the death of four persons due to COVID-19. This raises the death toll from the virus in Cyprus to 183,...

Crowding at Troodos; lots of fines by police

Lots of traffic was today seen at Troodos. In order to maintain order but also to monitor that people respected the measures aiming to...

Where to get antigen rapid tests on Sunday 24 January

The Health Ministry announced the following antigen rapid test sites for Sunday, 24 January 2021:   LIMASSOL Parking place Lidl supermarket, Limassol 08:30-16:30 Glafkos Clerides Park, Germasoyia 08:30-16:30 Municipal...

Larry King dies at 87

Larry King dies at 87. Photo taken at his concert at Hard Rock Live in Hollywood, Florida on January 25, 2012. (Reuters)

Taste

Squash soup

Ingredients: 1 kg pumpkin, cut into small cubes, approximately 5 cups 2 medium (400g) sweet potatoes, cut into cubes, approximately 2 ½ cups 1 chopped leek, only...

Mezedes

No visit to Cyprus is complete without enjoying the traditional meal of many small dishes known as ‘meze’. This large feast, which has been a...

Prawns with fried cheese, barley shaped pasta

Put the barley shaped pasta into a small pan with salted water, bring to a boil and when tender, drain. Peal the prawns leaving...

Salmon and shrimp sheftalies

Mix all ingredients for tabbouli in a bowl and keep to one side so flavours can combine. Prepare the sheftalies: wash and soak the casing...