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HDA Media And Political Bulletin – 29 June 2016

Brexit could cause ‘significant’ delays in getting new drugs to patients, industry warns

28 June 2016, The Pharmaceutical Journal, Elizabeth Zukkar

 

The Pharmaceutical Journal reports on the potential disruptions Brexit could bring to the medicines supply chain, such as significant delays to patients receiving new drugs. The location of the European Medicines Agency, currently based in London, will be discussed by the European Commission and the European Council. Rebecca Lumsden, head of science policy at the ABPI stated that “A stand-alone UK process would be the worst possible outcome”. In addition, the UK leaving the EU could be seen as a loss as the MHRA is currently undertaking a “big share” of the work in appraising medicine applications for EU approval.

 

UK science funding uncertain after Brexit vote

28 June 2016, pharmaphorum, Richard Staines

 

The future of European science funding is one of the many concerns raised after the EU Referendum result last Thursday. The UK Government has calmed these concerns, stating that money will continue while relations with Europe are resolved. One of the EU programmes at stake is Horizon 2020 which makes available 80 billion euros, in addition to any private investment attracted, for European R&D projects.

 

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Brexit could cause ‘significant’ delays in getting new drugs to patients, industry warns

28 June 2016, The Pharmaceutical Journal, Elizabeth Zukkar

 

Disruption feared “inevitable” if UK withdraws from EU drug regulatory system.

 

The European Medicines Agency works closely with the UK’s Medicines and Healthcare products Regulatory Agency, which undertakes a large proportion of the work in appraising medicine applications for EU approval

 

The UK pharmaceutical industry association has warned that if the UK adopts a stand-alone medicines licensing system following the referendum vote to leave the EU, there could be significant delays to patients receiving new drugs.

 

At the moment, most new drugs are approved through the European Medicines Agency (EMA)’s centralised system.

 

“A stand-alone UK process would be the worst possible outcome and has the potential to cause significant delays in UK patients accessing the right medicines at the right time,” says Rebecca Lumsden, head of science policy at the Association of the British Pharmaceutical Industry (ABPI).

 

Leaving the EU may also impact medicines and pharmacovigilance legislation in the UK, she adds: “Whilst we know that a withdrawal of the UK from the EU regulatory system would lead to inevitable disruption, our goal should be for any UK system to align or integrate with established international regimes.”

 

The EMA, a decentralised agency of the EU, is currently located in London. A spokesperson for the agency says its future location will be a decision for the European Council and European Commission, “if it comes to it”.

 

The UK leaving the EU could be seen as a loss for the EMA because the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s drug regulator, undertakes a proportion of the work in appraising medicine applications for EU approval. “It’s a big share,” says the EMA spokesperson.

 

The EMA’s scientific committee responsible for preparing opinions on medicines in the centralised procedure is the Committee for Medicinal Products for Human Use (CHMP). The CHMP’s medicine assessment is carried out by a rapporteur and a co-rapporteur who prepare the assessment reports and lead the discussions in the committee.

 

In 2015, the UK was appointed as rapporteur for 22 procedures and as co-rapporteur for 17, the EMA says.

 

“To date, for both human and veterinary products, the UK [has been] appointed as rapporteur for 15.9% authorised and pending medicines and as co-rapporteur for 9.6% valid and pending medicines,” the EMA spokesperson says.

 

The UK has also played a role in drug safety in particular, through the Pharmacovigilance Risk Assessment Committee (PRAC), an EMA committee that monitors safety issues for human medicines.

 

The UK was appointed as PRAC rapporteur for 16.2% authorised and pending products and as PRAC co-rapporteur for 12.4% valid and pending medicines, the EMA says.

 

Of the agency’s 890 employees, 60 (6.6%) are British nationals. Nearly 10% of its management positions are held by British nationals, including the agency’s executive director, the deputy executive director, heads of division, heads of department and the EMA’s senior medical officers and heads of advisory functions.

 

“No country has ever decided to leave the EU, so there is no precedent for this situation. It is too early to foresee the implications of this decision and we will be in close contact with the EU institutions,” the EMA spokesperson adds.

 

Following the referendum result, the MHRA says it will continue to focus on its public health role. “Working closely with government we will consider the implications for the work of the agency,” it says.

 

“We will continue to make a major contribution globally to improving public health through the effective regulation of medicines and medical devices, underpinned by science and research.”

 

Lumsden adds that the Brexit decision creates “immediate challenges” for future investment, research and jobs.

 

“The [pharmaceutical] sector is already beginning to work closely with the government to take steps that minimise business uncertainty, to send a message that the UK is open [to] the world, and that we should promote innovation for a strong, competitive UK economy.”

 

She adds: “What we do know is that the uncertainty that does exist has had an immediate impact on the placement of both research and development and clinical research, but we will do all we can to ensure that the UK continues to be at the forefront of global science research and development for the benefit of the NHS, industry and patients.”

 

UK science funding uncertain after Brexit vote

28 June 2016, pharmaphorum, Richard Staines

 

The future of European science funding is one of many matters thrown into confusion after Thursday’s Brexit vote, but the UK government has moved to calm concerns and says money will continue while  relations with Europe are resolved.

 

The EU’s research programme Horizon 2020 makes available 80 billion euros, in addition to any private investment attracted, for European R&D projects.

 

Many pharma and life science projects have been funded by Horizon 2020 through the Innovative Medicines Initiative, a public-private partnership between the European Commission and industry.

 

In a statement, Jo Johnson, minister for Universities and Science, said UK participants can continue to apply for the programme in the usual way.

 

“The referendum result has no immediate effect on those applying to or participating in Horizon 2020,” he said.

 

However the future of UK access to European science funding “will be a matter for future discussions,” according to a statement.

 

Jo Johnson is the younger brother of Boris Johnson, who led the Leave campaign to victory, but Jo was firmly in the Remain camp.

 

Minister Johnson is to give a briefing on the future of UK science and innovation later this week, and stressed that the UK would continues to play a leading role in European and international research.

 

He has reiterated that there will be no “immediate changes” following the referendum in circumstances of British citizens living in the EU, and European citizens living here. This includes people studying or working at UK universities.

 

This clarification has been necessary as many EU nationals have reported feeling unwelcome in the UK after the vote, in which fears about uncontrolled immigration was a leading issue.  The last few days have seen a very sudden and worrying rise in reported xenophobic and race-related incidents, which all politicians have condemned.

 

But the pharma industry is concerned about the uncertainties caused by Brexit. Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA) told pharmaphorum that he is concerned about the impact of Brexit on EU-funded pharma projects and would hinder collaborative R&D projects.

 

Sarah Rickwood, vice president of thought leadership for Europe at IMS Health said: “The question of scientific funding is one of the big issues. It is not necessarily affecting big pharma but it does affect universities and small pharma companies.”

 

Rickwood noted that loss of EU funding from Horizon 2020 and IMI was a concern, adding that Switzerland’s eligibility was restricted after its negative vote on mass immigration in 2014.

 

She added that although any future system would be likely to prioritise the skilled individuals who work in pharma, there is inevitably wider concern about restricting freedom of movement and immigration.

 

At present, she noted, it is the uncertainty about the eventual agreement has the most potential to damage.

 

Another issue affecting the scientific community could be barriers to collaboration, data sharing, infrastructures and public-private partnerships.

HDA Media And Political Bulletin – 29 June 2016

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