UK patients could be denied medicines in event of Brexit – biotechs

Leaving the EU could deny UK patients access to innovative drugs as pharma may decide it is not cost-effective to engage with a regulatory system covering only one country, the country’s life sciences trade body has warned.

The BioIndustry Association warned that pharma may not wish to engage with the UK regulator, the Medicines and Healthcare products Regulatory Agency, because the small size of the country’s market may not make the process worthwhile in cost terms.

In the build-up to a referendum on EU membership in June, the BIA said in a submission to the Science and Technology Committee that the UK represents 3% of the global market as opposed to the 27% represented by the EU.

According to the BIA “it is possible that drug companies would have to file a separate dossier, at an added cost, to launch their products in the UK.”

The BIA, which also gave evidence to MPs from the committee earlier this week, said in its submission that “this risks reduced patient access to new innovative medicines and the attractiveness of the UK as a location for inward investment.”

However the BIA gave no indication whether this had occurred in comparable non-EU markets such as Norway and Switzerland.

It also argued that the UK would be frozen out of the regulatory process in the EU, which is driven from the European Medicines Agency’s London headquarters. Many EU regulations would either have to be mirrored or accepted from outside the UK. This would mean it would have to follow a system it cannot influence.

Overall, the BIA said leaving the EU “would dilute the perception of the UK as a world leader in this global industry.”

The BIA also argued that the new European Unified Patent Court, expected to open in early 2017, will reduce costs associated with patent litigation. Europe’s intellectual property framework is important for life sciences as it helps encourage innovation by compensating for the long time needed for regulatory approval of products.

Other drivers for innovation are the Horizon 2020 research and innovation programme, which will provide 80 billion euros between 2014 and 2020 to support breakthroughs, discoveries and world firsts.

The Innovative Medicines Initiative, funded 50/50 by Horizon 2020 and pharma is also “relevant” to the industry, the BIA said.

EU membership also gives access to venture capitalist funding that invest in the UK, the BIA said. This includes the European Investment Fund that promotes creation and development of smaller businesses by guaranteeing loans and financing VC funds that invest in them.

However the BIA said that the “precautionary principle” had been misused in the past, allowing “political views to interfere with what should be appropriate regulatory regimes.”

The BIA’s intervention comes after several high-profile warnings from pharma about the potential fall-out should the UK choose to leave Europe.

Related articles:

AstraZeneca and Glaxo sign letter warning of European exit

Pharma warns of European exit – but British public needs more convincing

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.