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.

Five-year NHS strategy only mentions pharmacy twice

C&D, Emma Weinbren, 23 December 2015

The 5-year NHS plan only mentions pharmacy twice, compared to 13 references to GPs and 3 to nurses. The document promises a community pharmacy reform to improve primary care productivity but the nature of the reform is not specified. Another pledge is to increase access to primary care, in particular on weekends and evenings.

 

Pharmacy2U supply problems

PSNC, 24 December 2015

NHS England has issued a letter on the disruption to services that Pharmacy2U (P2U) is experiencing over the Christmas period.

The technical issues at P2U have resulted in some patients being unlikely to receive their ordered medicines until 11th January 2016.

The letter contains details of the arrangements being made to mitigate risk and inconvenience to patients.

NHS England letter – Important note regarding services provided by ‘Pharmacy2U’ over Christmas and New Year

 

Independents rally to NPA call for coordinated response to NHS England ‘efficiency’ plans

NPA, 4 January 2015

The National Pharmacy Association reports that hundreds of independents pharmacy have decided to take part in a joined-up response to the NHS proposal for “efficiencies”, including centralised dispensing and an increase of online medicine supply. This action will aim to:

  • Present a strong case to the Government and the NHS
  • Mobilise support from politics and the general public

 

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Five-year NHS strategy only mentions pharmacy twice

C&D, Emma Weinbren, 23 December 2015

NHS England plans to “support community pharmacy reform”, according to the document, but does not specify what that will involve

The strategy also references the role of pharmacists in GP practices

The Delivering the Forward View document, released yesterday (December 22), makes reference to the role of pharmacists in GP practices and improving primary care productivity by “supporting community pharmacy reform”.

But there is no mention of what the reform will entail in the document, designed to help the NHS achieve the goals set out in last year’s Five Year Forward View.

The original document outlined a vision for pharmacists to form large-scale primary care practices with GPs and pledged to make “far greater use” of the profession.

This week’s update stresses the importance of “balancing” the NHS budget in realising the plans, which aim to give 20% of the population “enhanced access” to primary care by March 2017. They also include improving access to primary care at weekends and evenings.

But it makes no mention of using community pharmacies to achieve this vision.

The document makes 13 references to GPs and three to nurses.

In June, NHS England’s deputy chief pharmaceutical officer Bruce Warner told C+D that pharmacy has a “huge role to play” in NHS England’s plans for the future.

 

Independents rally to NPA call for coordinated response to NHS England ‘efficiency’ plans

NPA, 4 January 2015

Hundreds of independent pharmacists have already registered to take part in a coordinated response from the independent sector to NHS England proposals for ‘efficiencies’, such as centralised dispensing and more online supply of medicines.

They will be given resources and hands-on support to build the evidence base required to make a compelling case to Government and NHS mobilise public opinion and political support for local pharmacies.

The NPA’s overall approach is to robustly oppose the current policy drift, which, together with funding cuts, risks undermining the community pharmacy network. At the same time, the NPA will help independents adapt to meet the genuine long-term challenges that exist in terms of patient expectations and NHS productivity.

NPA Chairman, Ian Strachan, said:

“The Government is conducting a dangerous experiment which could see local pharmacies close, thereby reducing people’s access to pharmaceutical and healthcare advice, and putting extra pressure on GPs and hospitals.  The current drift of policy puts at risk a part of the health system that holds the key to solving many of its problems. Patients would be the biggest losers.

“The Government’s approach is to combine funding cuts with jumbled proposals for productivity gain, including support for ‘large scale automated dispensing’ and increased online supply of medicines.  The proposals imply that pharmacy is just a distribution mechanism for product – rather than a valuable health and social care asset at the heart of communities.

“Fundamentally, the answers lie in universal implementation of what we know works well, not about relying on unproven measures that could have serious unintended and irreversible consequences.

“Our voice is most powerful when NPA members are actively involved, so we are asking independents to step forward at what could be an important moment in pharmacy history.  It is vital that we all play our part in the coming months.”

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

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