HDA UK Media And Political Bulletin – 25 April 2017

Don’t let Brexit disrupt European Medicines Agency, warn pharma leaders

Pharmaphorum, Andrew McConaghie, 24 April 2017  

 

Heads of research & development at major pharmaceutical companies have signed an open letter from the European Federation of Pharmaceutical Industries and Associations (EFPIA) to warn of the risks associated with the relocation of the European Medicines Agency. Calling for a decision to be made at the European Council of Ministers in June, a spokesperson for the EFPIA stated that its main concern was “regulatory continuity”.

 

The full letter is available here.

 

Decisions, decisions

The Pharmaceutical Journal, 21 April 2017

 

The Pharmaceutical Journal discusses the decisions lying ahead for the UK Government to exit the European Union and transfer EU laws to the UK. In pharma, the future of drug approval or patient access to new medicines remain unclear, and more particularly the future role of the Medicines and Healthcare products Regulatory Agency (MHRA) and how it can unpick the web of mutual reliance with its EU counterpart, the European Medicines Agency (EMA).  While the MHRA brings huge experience and expertise to the EMA, the UK represents only 3% of the global drug market compared to 25% for the European Union. Nonetheless, Brexit offers opportunities for the MHRA who should adopt a system of reciprocal regulatory approval if it splits from the EMA.

 

The impact of a ‘hard Brexit’

Pharma Times magazine, Ana Nicholls, May 2017 issue

 

Pharma Times reviews what the Prime Minister’s statement “no deal for Britain is better than a bad deal” would mean for the pharmaceutical sector. A ‘Hard Brexit’ scenario broadly forecasts a cut in health expenditure and pharmaceutical sales combined with a rise in the UK pharmaceutical’s spending. While this is not the core forecast, the healthcare sector will still face high disruption in areas such as recruitment, patients’ reciprocal rights to treatment, medical research and procurement.

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Don’t let Brexit disrupt European Medicines Agency, warn pharma leaders

Pharmaphorum, Andrew McConaghie, 24 April 2017  

 

Heads of R&D at all major pharma companies have come together to express their concerns about severe disruption to the European Medicines Agency (EMA) as it faces a Brexit-induced relocation.

 

The UK’s decision to leave the European Union by 2019 means that the EMA, the world’s second most important drugs regulator after the US FDA, must leave its current home in London.

 

The open letter, published by Europe’s pharm industry association EFPIA, is signed by 19 big pharma R&D leaders, who have called for a swift resolution to the issue.

 

They have urged for a decision to be made in June at the meeting of the European Council of ministers.

 

This summit is where the remaining ‘EU27’ will begin to decide on their collective position on a huge number of questions raised by Brexit, including the terms of the UK departure and life after 2019.

 

The open letter states that the EU member states have benefitted from the EMA’s co-ordination in approvals and pharmacovigilance for two decades, and warns that this mustn’t be disrupted.

“It is a stark and alarming reality that such fundamental activities would undoubtedly be impeded were the operations of the agency to be disrupted as a result of the United Kingdom’s exit from the EU.”

 

It added: “To put it concisely: in the event of obstruction or failure, Europe possesses no backup option.”

 

This warning chimes with comments already made by EMA chief Guido Rasi in the media.

 

Rasi says the uncertainty around its future has already prompted some staff to leave, and warns that a badly-handled transition could ultimately disrupt the approval of new medicines.

 

Major cities in EU27 nations, including Dublin, Barcelona, Amsterdam and Stockholm are queueing up to become the new location for the organisation, which currently around employs 900 experts at its base in Canary Wharf.

 

The UK’s chief Brexit negotiator, David Davis, has even suggested that the UK could retain the EMA as part of a broad negotiation with Europe’s leaders – even though this idea will almost certainly be dismissed by the EU27.

 

Among the signatories of the open letter are Novartis’s research supremo Jay Bradner, Elias Zerhouni’s R&D chief at Sanofi, Patrick Vallance, president of R&D at GSK and Pfizer’s Mikael Dolsten.

 

These leaders represent respectively a Switzerland, France (EU), UK and US headquartered firms – but an uninterrupted flow of decisions at the EMA is vital to all global companies, as collectively it represents the second most important global market, even once the UK departs.

 

The letter adds that the “well oiled machinery”  of the EMA continues to function with the current level of “internationally-acknowledged efficiency”.

 

A spokesman for EFPIA says the pharma organisation has no view on whether the EMA could stay permanently in the UK or not, or if it could remain in London after 2019 under transitional arrangements.

 

The spokesman said the pharma industry has been following the Brexit process with “both concern and interest,” and says the impetus for the open letter has come from its members and from the EFPIA board.

 

Asked if EFPIA had a view on the ideal timelines for decision-making and relocation of the EMA, the spokesman concluded: “This is a matter for the European institutions and our only concern is regulatory continuity.”

 

Given that the EMA is such as prized institution in Europe, competition to be its new home will be fierce. This will mean that the decision-making process will have to observe due process, which suggests that a final ‘winner’ from the process will take time to emerge.

 

The EMA receives 36,000 expert visits every year, and EFPIA points out that any EU city must meet fundamental logistic demands, such as having a large number of hotel rooms to host these legions of visiting experts.

 

Decisions, decisions

The Pharmaceutical Journal, 21 April 2017

 

On 29 March 2017, the UK’s EU representative Sir Tim Barrow hand-delivered the letter signifying the UK’s official intention to leave the EU within two years. In the days since, the European parliament has agreed a negotiating stance and the UK government has released its white paper on the ‘Great Repeal Bill’ to transfer EU laws to the UK. Formal discussions await. In the increasingly likely event of a so-called ‘hard Brexit’, the future of relationships between Britain and the many institutions that have been formed as a result of the country’s 40-year EU membership remains unclear. The UK government has remained vague about what Brexit will really mean, and many decisions must now be taken — for example, on how new drugs will be approved for use and monitored safely in the UK. A preferred post-Brexit model for patient access to new medicines may also be required. The future role of the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), and how it can unpick the tangled web of mutual reliance with its EU counterpart, the European Medicines Agency (EMA), also remains unclear.

 

The EMA does not have its own scientific assessor for drugs, but relies on 50 medicines regulatory authorities in the EU/European Economic Area (EEA), including the MHRA, to evaluate drug submissions and monitor safety reports. The MHRA brings a huge amount of expertise and experience to the European drug regulatory landscape, a contribution that is underpinned by its access to comprehensive external advice via the UK’s Commission on Human Medicines and its expert advisory groups across the range of drug disciplines. The MHRA also contributes to the EU regulatory network of national competent authorities in decentralised and mutual recognition procedures. For example, the MHRA is among the countries most commonly selected to account for around 4,000 licensing procedures across the EU/EEA. It is also responsible for about 50% of new marketing authorisation applications submitted in the UK.

 

Brexit means that the MHRA will lose the benefit of work-sharing for those applications in which it does not act as co-rapporteur at the EMA, which equates to around 70% of new marketing authorisation applications. However, the MHRA has committed to continuing to prioritise a full and active role in regulatory procedures for drugs. If the MHRA is to duplicate the EMA’s work, it would need to substantially increase in size. And such expansion is not cheap.

 

The UK as a drug market is dwarfed by the EU, which represents 25% of the global market. The UK alone accounts for only 3%, making it of less importance to pharmaceutical and biotech companies when planning product approvals and launches. Recent announcements from GSK and Takeda, headquartered in London and Osaka, Japan, respectively, confirming long-term investments in the UK are encouraging signs for the UK’s place in research and development and manufacturing. But the uncertainty surrounding the future of the UK pharmaceutical industry means confidence is low among industry leaders. One major uncertainty is how European pharma companies can do business with and inside the UK following a hard Brexit. Similarly, there is little understanding of any possible knock-on effect the disruption will have on the global pharmaceutical industry.

 

The UK is one of the top five European markets, and is part of the core global market for launching innovative new drugs. However, financial problems in the NHS and barriers in its local organisations raise challenges for market access to new drugs, especially for rare diseases. In a report published on 16 March 2017 on access to rare disease treatments, data — collected and analysed by Office of Health Economics Consulting, and commissioned and funded by Dublin-based pharmaceutical company, Shire — showed that the average time to the treatment of rare diseases being funded following EMA authorisation in England is just under 28 months, compared with 9 months in Italy, and almost immediate reimbursement in Germany.

But Brexit will also create opportunities for the MHRA, which should adopt a system of reciprocal regulatory approval if it splits from the EMA. The MHRA’s influence and expertise, and its central involvement in EU regulatory process and granting marketing authorisations, may be a key bargaining point for the UK in any negotiations regarding existing marketing authorisations and future collaborations.

 

One option for negotiation would be to seek continued mutual recognition, which means the UK would remain as attractive for trials and early drug introductions as it is now. But this would also preclude the UK departing from EU rules on issues such as clinical trials, seen by some as a potential opportunity afforded by Brexit. The EU Clinical Trials Regulation, which aims to harmonise the assessment and supervision processes for clinical trials throughout the EU, is due to come into force in 2018. The regulation provides more streamlined approaches for the multi-centre trial approval process and also provides more coordination between national competent authorities and ethics committees, both of which should benefit sponsors. The UK should consider implementing equivalent legislation in the UK post-Brexit. But to do so, it would need some form of agreement with the EU. Companies conducting clinical trials in the UK would need to prove that they are complying with standards that are equivalent to those in the EU, otherwise these trials would not be able to go ahead because they would be considered to be taking place in a third country.

 

The UK government may decide to go down the route of divergent regulation, in line with talk of leaving the European single market and standing beyond the reach of the European Court of Justice. If so, the MHRA and NICE may have a role in advising on changes in regulatory processes and on what the UK can do to limit damage to clinical trials and new product introductions. Unilateral recognition of drugs approved in Europe or the United States to retain the UK’s prompt access to new drugs, might be one possibility.

 

The impact of a ‘hard Brexit’

Pharma Times magazine, Ana Nicholls, May 2017 issue

 

In January, the prime minister, Theresa May, warned the EU that “no deal for Britain is better than a bad deal” when it comes to Brexit. Although her government is now edging away from that position, the statement raised the question of what no deal would actually mean for the pharma industry

 

To answer the question of what a ‘hard Brexit’ would mean, The Economist Intelligence Unit recently assessed how our economic and healthcare forecasts would change if the UK did drop out of the EU in 2019 with no deal at all – which means no mutually agreed transition arrangement, no immediate prospect of a formal trade agreement, and scrambling even to assert its trade rights under World Trade Organization (WTO) rules. We drew up a detailed Hard Brexit scenario of how it could happen, and compared that to our baseline forecast, which is that the UK will manage to secure a phased agreement (a scenario we call Softish Brexit).

 

Under the Hard Brexit scenario, we assumed that the negotiations that are now underway would break down in late 2017 or early 2018, probably because of disputes over free movement of labour. When the two-year transition period ended in 2019, the UK would have to renegotiate its existing EU trade agreements under its own name (including WTO ones). Even under the best circumstances, this would take several months. In the meantime, trade would be disrupted and that would lead to a dramatic slowdown in the economy, with GDP growth falling to 0.3% by 2019 and proving very slow to recover. By 2021 total GDP would be around 2% lower than under Softish Brexit.

 

One effect would be to cut health expenditure and pharmaceutical sales. We calculate that, given lower tax revenues to fund the NHS and lower consumer spending on health, total health spending in 2021 would be £2bn lower. Compared with projected total spending of £207bn, that is not a huge amount (although it is on top of the £22bn in NHS ‘efficiencies’ already expected). That is largely because we assume that, as now, health spending would be ring-fenced in government budgets, and even in household budgets. However, the effect would be exacerbated if the government, instead of adopting an expansionary monetary policy to dampen the effects of Hard Brexit, instead reacts by trying to turn the UK into a low-tax economy, competing with the likes of Ireland. That could cushion business, but it does mean that in the short term there would be even less money for the NHS.

 

‘The economic damage of Brexit will be limited, although we still expect growth to be slower than it would have been inside the EU’

 

Moreover, one counter-intuitive effect of our scenario is that we actually expect the UK’s pharmaceutical spending to rise under a Hard Brexit scenario, ending up around £600m or 2.8% higher than it would be under a Softish Brexit. That is largely because we expect the exchange rate to be worse under Hard Brexit, which would make imported drugs more expensive – and the UK runs a big trade deficit in pharma. One sideeffect of this extra spending on drugs will be less money for other parts of the healthcare system. Given that we also expect that NHS wages will go up as it becomes more difficult to recruit staff, the squeeze on actual patient spending will be much harder than the headline numbers seem to suggest.

 

To repeat, this is not our core forecast. Although negotiations will be difficult and there are multiple points where talks could break down, we do still think that the UK and EU will manage to agree a transition deal (probably at the last minute). Under this scenario, the UK would leave the single market in 2019 but would gradually phase in a free-trade deal and customs agreement with the EU. In that case, the economic damage of Brexit will be limited, although we still expect growth to be slower than it would have been inside the EU.

 

The healthcare sector will still face huge disruption over recruitment, patients’ reciprocal rights to treatment, medical research and procurement. As for the pharma industry, it will still face higher trade barriers. There would be no actual tariffs on pharmaceutical trade under either of our scenarios – even the WTO rules set tariffs at zero for humanitarian reasons. However, the UK pharma industry is relying on an amicable deal with the EU to reduce the non-tariff barriers. If we fail to secure EU agreement on issues such as mutual recognition of marketing approvals, our ability to secure third-party trade deals, harmonised rules on clinical trial data, or the ability to be involved in pan-European research projects, then the effects will be far-reaching.

 

Softish Brexit in itself will be no picnic. The European Medicines Agency will still leave the UK and the pharmaceutical industry will still find it harder to trade in the EU. However, as the House of Commons Foreign Affairs Committee warned in its March report, a Hard Brexit would be ‘a very destructive outcome leading to mutually assured damage for the EU and the UK’. Let’s hope it doesn’t come to that.

Media Summary

ENVI ‘welcomes’ UK’s continued membership in EMA
Politico, Helen Collis and Marion Solletty, 23 March 2017

The European Parliament’s environment committee (ENVI) has urged that, even after Brexit, the UK should remain a member of EU agencies including the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control. Repeating calls by other health ministers, the ENVI committee also called for a “swift agreement” on the relocation of the EMA.

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ENVI ‘welcomes’ UK’s continued membership in EMA

Politico, Helen Collis and Marion Solletty, 23 March 2017 

Even after Brexit, Brits’ membership in EU agencies including the European Medicines Agency and the European Center for Disease Prevention and Control should be welcomed, the European Parliament’s environment committee urges.

These agencies’ work “should not be compromised” due to Brexit, which “should not lead to a lowering in standards,” the ENVI committee stressed in an internal document, obtained by POLITICO,  submitted for possible inclusion in the Parliament’s future Brexit resolution.

It “welcomes continued participation by the U.K. in these agencies” and expressed “a preference” for the U.K. to remain part of the Registration, Evaluation, Authorization and restriction of Chemicals (REACH) process.

The calls contradict recent comments from U.K. Health Secretary Jeremy Hunt. He said it would be unlikely the U.K. retains membership of the EMA since this would mean being subject to EU jurisdiction — a red line Prime Minister Theresa May is not prepared to cross.

Repeating the calls of other health ministers, the ENVI committee called for a “swift agreement” on the relocation of the EMA and “transitional arrangements … to limit the loss of skilled staff and their vital expertise.”

The committee favored continued cooperation and financial contribution to the EU Health program by the U.K., with payments continuing to British beneficiaries.

It also urged continued cooperation on health and public health issues, including sharing expertise and contributing to the European Reference Networks.

ENVI said the U.K. should continue to abide by the bloc’s environmental policies on climate, emissions and air pollution.

Media Summary

Pharma criticises ‘heavy handed’ NICE affordability test

Pharmaphorum, 23 January 2017

The National Institute for Health and Care Excellence (NICE) and NHS England have outlined measures to cut the costs of expensive new medicines. Part of the plan involves fast-tracking medicines with a low budgetary impact to patients. Alongside this, proposals for a budget impact assessment – an ‘affordability check’ – constitute a less welcome part of the plan. This would mean that any drug looking to cost the NHS £20m or more per year would raise affordability discussions between a pharma company, NICE and NHS England. Above all, NHS wants to keeps its budget impact down. Proving to be a point of controversy with pharma companies and patient organisations, this NHS objective – manifested in the new affordability check – has already stirred considerable calls for renegotiation.

Simon Harris is trying to lure EU medicines agency to Dublin

The Irish Examiner, Stephen Rogers, 23 January 2017

Today, Irish Health Minister Simon Harris will visit London with the hope of convincing the European Medicines Agency to relocate to Dublin. In the wake of the Brexit vote, various countries have been courting the Agency. “I am mindful of the consequences of Brexit for the agency and I believe that it will be essential to minimise the impact of a relocation, in particular by finding a solution that maximises retention of existing staff,” said Mr Harris. Mr Harris has said he will follow up today’s visit with a series of meetings in early February with officials and stakeholders in Brussels. Staff retention and Dublin’s English-speaking status are being presented as highly beneficial in providing a smooth transition for the Agency’s departure from Britain.

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Pharmaceutical Price Regulation Scheme PPRS Payment for 2017: Written Statement

Parliament UK, Nicola Blackwood (Parliamentary Under-Secretary of State for Health), 20 January 2017

The Department of Health and the Association of the British Pharmaceutical Industry are to amend the 2014 Pharmaceutical Price Regulation Scheme (PPRS) to ensure that the scheme continues to deliver its objectives of predictability and stability to Government and industry. Additionally, it looks to safeguard costs, so that branded medicines to the NHS stay within affordable limits. Implicit in this is the Government’s recognition of the pharmaceutical industry’s contributions, and the financial challenges facing the NHS. The Department of Health has published a document setting out further details entitled “Pharmaceutical Price Regulation Scheme (PPRS) 2014: revised payment percentages at December 2016”. It can be read in full here.

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Pharma criticises ‘heavy handed’ NICE affordability test

Pharmaphorum, 23 January 2017

Plans to cut the cost of expensive new medicines could mean delays getting them to patients in England, according to the UK pharma industry.

NICE and NHS England have been consulting on changes to processes that will fast-track medicines with low budgetary impact to patients.

But also included is a proposal for a budget impact assessment – a kind of ‘affordability’ check.  This would mean any drug set to cost the NHS £20 million or more a year would trigger affordability discussions between a pharma company, NICE and NHS England.

Above that threshold, NHS organisations will begin talks with drug companies to try to get the price down.

NHS England has pushed for the new budget impact assessment to prevent problems similar to those caused by hepatitis C drugs such as Gilead’s Sovaldi (sofosbuvir). NICE ruled Sovaldi to be cost effective – but this didn’t reflect the overall, upfront cost – the affordability of the drug.

NHS England has resorted to rationing to keep its budget impact down, something which has proven controversial with pharma companies and patient organisations.

In 2015/16 NHS spending on Gilead’s Harvoni (sofosbuvir+ledipasvir) and Sovaldi for hepatitis C was £154 million, although AbbVie’s Humira (adalimumab) inflammatory diseases drug had the largest budget impact, costing the NHS almost £417 million.

The industry says that the new affordability check is unfair – as NICE already screens new medicines for cost effectiveness, and the PPRS pricing system limits overall NHS drug spending.

ABPI chief executive, Mike Thompson, said: “The ABPI agrees with the NHS England’s objective of developing a workable solution for managing the introduction of new medicines which are likely to create significantly high costs to the NHS.”

“However, given that all new drugs approved by NICE have already gone through a process to ensure they are cost-effective and clinically beneficial, the proposal to impose a £20million budget cap on these medicines is both heavy-handed and unrealistic and will mean more patients face delays in accessing appropriate NHS care.

“Better long term planning by the health service would ensure that major breakthroughs are managed into the NHS in an appropriate and affordable way and with less disruption.”

The ABPI said it supports plans to fast-track medicines with an estimated budget impact of less than £10,000 per Quality Adjusted Life Year.

But it and UK biotech industry association the BIA both warned that NICE’s proposals could delay or prevent access to drugs for ultra-rare diseases.

The consultation also proposes a £100,000 cost per QALY threshold for rare and ultra-rare disease drugs would receive automatic funding.

Above this threshold, ultra-rare disease drugs would receive cost-effectiveness assessments and the BIA and ABPI are concerned this could lead to many such drugs being rejected or delayed.

“We believe that this will have a detrimental impact on the development of new products for those who desperately need them and that this this proposal should be paused while a better solution is identified,” said Thompson.

These new checks on affordability send out a message is in clear contradiction to the government’s proposed life sciences industrial strategy.  Theresa May’s government is promising to help make the UK a world leading life sciences market, but pharma and biotech says this can’t be fully achieved if the NHS doesn’t use its new medicines.

This argument is one that will be clearly played out behind the scenes, but as the government is currently refusing to give the NHS extra money to cope with growing demand, it is also unlikely to give way on the new proposals for NICE.

There is some hope that the ABPI and the government could negotiate a new ‘value-based’ pricing system, but this is unlikely to emerge until 2019, after the existing PPRS pricing system expires.

Simon Harris is trying to lure EU medicines agency to Dublin

The Irish Examiner, Stephen Rogers, 23 January 2017

Health Minister Simon Harris will today travel to London to try to convince the European Medicines Agency of the merits of relocating to Dublin.

The EU agency will have to leave Britain as a result of Brexit and the Government has made no secret of its desire to attract it to Ireland.

Today, Mr Harris will meet with the agency’s executive director, Professor Guido Rasi, and members of his team.

“I am mindful of the consequences of Brexit for the agency and I believe that it will be essential to minimise the impact of a relocation, in particular by finding a solution that maximises retention of existing staff,” said Mr Harris.

“The Government has endorsed my request that Ireland would seek to have the EMA relocate to Dublin.”

Dublin is being presented as a viable location on the back of its ability to maximise retention of existing staff; the fact that it is an English-speaking location and English is the agency’s working language; and the fact that the Health Products Regulatory Authority here would be able to provide strong support.

Mr Harris has said he will follow up today’s visit with a series of meetings in early February with officials and stakeholders in Brussels.

Sue Sharpe: Why 2017 will be a ‘testing’ year

Chemist and Druggist, Thomas Cox, 4 January 2017

 

Sue Sharpe, PSNC Chief Executive, discusses the “difficult challenges” the pharmacy sector will face in 2017. In her New Year address on January 3rd, she said “We are working in an increasingly hostile environment and the financial stringencies biting across the whole of the public sector will continue for several years”. Sue Sharpe also recognised the efforts already made by the sector since funding cuts were announced in December 2015.

 

Brexit could disrupt EU drug approvals – EMA chief

Pharmaphorum, Richard Staines, 4 January 2017

 

Pharmaphorum further reports on the head of the European Medicines Agency’s warning that Brexit could disrupt the drug approval process across Europe, with knock-on effects for the wider industry. Speaking to the Financial Times, Guido Rasi explained that Brexit had already resulted in disruptions for the agency with seven senior executive members quitting since the vote in June. Due to the complex structure of the organisation, the EMA would require “the longest possible time” to manage a relocation.

 

Return on investment falls for pharmaceutical industry

The Pharmaceutical Journal, 4 January 2017

 

An industry analysis published by Deloitte found that return on investment in drug R&D achieved by the pharmaceutical industry fell to 3.7% in 2016. This figure is the lowest in six years. In the context of acute public scrutiny on drug prices, this report raises questions about productivity and returns on innovation.

 

ABPI launches new film and suite of resources about the value of the UK pharmaceutical industry

ABPI, 4 January 2017

 

The ABPI launched a new film to showcase the history and value of the UK pharmaceutical industry. Alongside the launch of the film, up-to-date online resources aimed at providing a comprehensive overview of the UK are available. With over 120 slides divided in 5 chapters, the online content demonstrates the value of medicines and vaccines and the pharmaceutical industry’s worth to the UK economy.

 

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Brexit could disrupt EU drug approvals – EMA chief

Pharmaphorum, Richard Staines, 4 January 2017

 

Brexit could disrupt the approval of drugs across all of Europe, with a knock-on effect on industry, the head of the European Medicines Agency has warned.

 

In an interview with the Financial Times, Guido Rasi, executive director of the European Medicines Agency said Brexit is already causing disruption at the London-based agency, with seven senior executive members quitting following the UK’s vote to leave the EU last June.

 

But the decision to quit the EU could have even wider ramifications in the event of a “hard Brexit” style decision. This would guarantee that the EMA would have to relocate away from London, and the disruption could affect the running of the agency.

 

A poll conducted in early December by pharmaphorum of 11 UK pharma industry leaders (including six UK general managers) found most (seven, 64%) feared that Brexit would cause “long term damage to the UK pharmaceutical industry”.

 

This damage would not just be limited to the UK.

 

Rasi said that running the EMA is like an “assembly line”, with complex logistics organising meetings, which is why it would need “the longest possible time” to organise any move.

 

It would take at least two years to move the agency away from London, said Rasi, to ensure recent improvements in approval times to not stall, or move into reverse.

 

This could make Europe less attractive to pharma and biotech countries considering investing in the region, said Rasi.

 

“If we are losing expertise we have to focus on managerial things, HR issues, of course our capacity and commitment to provide additional support to this community would be decreased, and that would make a fragmented Europe in terms of pricing and enforcement. We will give the opposite of being competitive.”

 

A staff survey presented to the agency’s board last week showed about 50% would leave if the EMA moves to an undesirable city.

 

Rasi added that morale is becoming “worse and worse” at the agency had been affected by the political uncertainty, and there is a lack of candidates in selection procedures.

 

His comments echoed views expressed by senior figures at the agency’s annual review of the year meeting, held last month in conjunction with TOPRA.

 

The figures expressed frustration that they felt like passengers while politicians decide the future and location of the EMA.

 

The EMA employs almost 900 people – but also faces a large loss of capacity in the event of a move.

 

Rasi noted that the UK Medicines and Healthcare Products Regulatory Agency approves around a fifth of all drugs in the EU.

 

The UK’s pharma industry is lobbying to keep the UK within the European regulatory system after Brexit – and Rasi warned that severing the MHRA from the EU’s network would present huge challenges.

 

Rasi warned that a hard Brexit would require the creation of a standalone UK regulator, and would be a huge undertaking.

 

“I assume if we are going to lose the 20% [of capacity], it means they [the MHRA] are going to lose the 80%,” said Rasi.

 

Return on investment falls for pharmaceutical industry

The Pharmaceutical Journal, 4 January 2017

 

The return on investment in drug research and development (R&D) being achieved by the pharmaceutical industry fell to 3.7% in 2016 — the lowest figure in the past six years, according to an industry analysis published by Deloitte.

 

The analysis found that projected peak sales per new product have fallen by 11.4% year on year since 2010 to reach an average US$394m.

 

The findings, published in Deloitte’s report ‘Measuring the return from pharmaceutical innovation 2016: Balancing the R&D equation’, are based on its 2016 analysis of the R&D spend by the global top 12 research-based life science companies: Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck & Co, Novartis, Pfizer, Roche, Sanofi and Takeda.

 

The companies have launched 233 products over the past six years and developed another 376 products to reach late stage pipelines, with a total sales forecast of US$1,697bn, the report reveals.

 

During 2016, the costs of bringing a new drug from discovery to launch have stabilised — from US$1,576m in 2015 to US$1,539m in 2016 — but peak sales per product have continued to fall.

 

Colin Terry, consulting partner for European life sciences R&D at Deloitte, says the continuing fall in projected return is a “real issue” for the global industry: “As costs per product remain high, sales projections decline, and given it now takes the industry over 14 years to launch a drug, real questions should be raised about productivity and returns on innovation.”

 

He says drug price is the “most publicised challenge, with political and public scrutiny on the topic intensifying”.

 

“The majority of companies are struggling to achieve historical peak sales despite continuing to launch many new products. They are also increasingly looking for returns from treatments in smaller patient groups.”

 

ABPI launches new film and suite of resources about the value of the UK pharmaceutical industry

ABPI, 4 January 2017

 

The Association of the British Pharmaceutical Industry (ABPI) has launched a new film and an accompanying suite of up-to-date online resources aimed at providing a comprehensive overview of the UK pharmaceutical industry.

 

A short film – ‘Only Just Begun’ (available at https://youtu.be/8KzjP37Fv2A), produced in association with Artemis Films, celebrates the history of the UK pharmaceutical industry in changing the lives of patients, and the people involved in its past, present and future. It uses original footage and archive footage made available by ABPI members AstraZeneca, GSK, Novo Nordisk and Pfizer.

 

The new online content (available at http://www.slideshare.net/ABPI_UK/an-update-on-the-uk-research-based-pha…) features over 120 slides (split into chapters) that demonstrate the value of medicines and vaccines, the pharmaceutical sector’s worth to the UK economy, and the strides the sector has made to improve patient and health outcomes.

 

​Introduction: An update on the UK research-based pharmaceutical industry

  • Chapter 1: Medicines and vaccines
  • Chapter 2: Trailblazing science
  • Chapter 3: Putting patients first
  • Chapter 4: Letting innovation flourish
  • Chapter 5: The future
  • Case study examples from industry

 

Aileen Thompson, ABPI Executive Director of Communications, said:

 

“Medicines and vaccines help us live longer, better lives and offer one of the greatest hopes we have for the future of human health. These new resources tell the story of what we do and why, and we hope they will inspire others to find out more about the life-changing discoveries, vaccines and medicines which our members deliver.”

London-based regulator for EU drugs fears staff exodus

Financial Times, Gonzalo Viña, 3 January 2016

 

Guido Rasi, executive director of the European Medicines Agency (EMA), the European Union’s London-based drug regulator, warned that the agency has already lost an unprecedented number of senior staff and as much as half could leave if the transition is not carefully managed. This warning is further reminder of the administrative and logistical complexity which will result from the UK exiting the European Union. Considering the importance of the MHRA’s role in approving medicines in the EU, some see the relocation of the EMA as a bargaining chip for the UK in Brexit negotiations. However, the UK is set to be lose more with the MHRA facing greater challenges if it stands on its own. The UK pharmaceutical industry is lobbying against the creation of a standalone British regulator, arguing this would turn the UK in a third-class market.

 

Class 4 MHRA drug alert – Arava (leflunomide) 10mg film-coated tablets (Sanofi-Aventis Deutschland GmbH)

PSNC, 3 January 2016

 

Drug alert number: EL(17)A/01

 

Date issued: 3rd January 2017

 

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use, for certain batches of:

 

Arava (leflunomide) 10mg film-coated tablets (Sanofi-Aventis Deutschland GmbH)

 

Sanofi on behalf of Sanofi-Aventis Deutschland GmbH, has informed the MHRA that there is an error in the Braille on 1 in 5 cartons from certain batches. On affected cartons, the strength of the product reads ‘20mg’ instead of ‘10mg’ in Braille. The printed text is correct on all packaging.

 

There is a risk to patients who have compromised eye-sight and who rely solely on Braille to determine their tablet strength. Packs with the specified batch numbers should not be dispensed to patients who rely solely on Braille.

 

To view the alert please visit the MHRA website.

 

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London-based regulator for EU drugs fears staff exodus

Financial Times, Gonzalo Viña, 3 January 2016

 

The head of the EU’s London-based drugs regulator said the agency had lost an unprecedented number of senior staff since the Brexit vote and warned that as many as half could walk out unless its future is handled properly.

 

For Guido Rasi, executive director of the European Medicines Agency, its probable relocation once Britain leaves the EU poses a unique challenge but is also a stark reminder of the broader administrative and logistical quagmire that is likely to follow Brexit.

 

The EMA’s Canary Wharf headquarters plays host to 36,000 national regulators and scientists each year from across the continent who come to London to approve the safety and efficacy of drugs for the EU’s 500m people. London’s 890-strong secretariat plays a central role in coordinating that work.

 

Prof Rasi said seven senior executives had quit the agency since the referendum, more than in the past decade put together. A staff survey presented to the agency’s governing board last week showed that about 50 per cent would leave in the event of relocation to an undesirable city.

 

We are experiencing a lack of candidates in the selection procedures, we are experiencing many more people leaving the agency

 

For the majority still in place, morale has plunged to worrying depths, Prof Rasi adds: “That’s becoming worse and worse; the uncertainty, of course, is generating all the bad things you might expect. We are experiencing a lack of candidates in the selection procedures, we are experiencing many more people leaving the agency.”

 

The EMA is also likely to suffer a large loss of capacity because of the work the UK regulator does on its behalf. The Medicines & Healthcare Products Regulatory Agency punches above its weight and currently approves about a fifth of all medicines in the EU.

 

While the loss to the EMA might raise the hopes of Brexiters looking for bargaining chips in negotiations with the EU, Prof Rasi warns that the challenge facing the UK regulator will be even greater.

 

“I assume if we are going to lose the 20 per cent, it means they are going to lose the 80 per cent,” Prof Rasi said.

 

The pharmaceuticals industry in the UK is lobbying against the creation of a standalone British regulator following Brexit, arguing that severing ties with Europe would turn the country into a third-class market, where drugs are approved in larger countries first. Some ministers — mainly those in favour of a “hard Brexit” — are said to want a new UK body.

 

Without expressing any preference, Prof Rasi said a “good deal” could still see Britain as part of the EU regulatory network.

 

“That, I think, might affect the decision to relocate or not, but that’s really beyond me,” he said.

 

Sweden is the latest EU country to pitch for the EMA to relocate to its capital. Others have included Denmark, Spain, Italy, Ireland and France. Prof Rasi said the number one priority was transport “connectivity” followed closely by a long enough window — two years — to relocate the headquarters.

 

Running the EMA, he said, is like running an “assembly line, which means they [delegates] have to come at the right time, in the right room, in the right sequence, to meet the right people. So, it is a machinery, very complex, so the logistics matters a lot; that is my concern. That’s why I would like to have the longest possible time to organise.”

 

Without a proper amount of time — a minimum of two years — Prof Rasi fears the approval of drugs in the EU could suffer and recent improvements in approval times could stall or even go into reverse, leaving Europe’s burgeoning biotech sector to seek approval in the US or Japan or in future in Korea or Singapore.

 

“If we are losing expertise we have to focus on managerial things, HR issues, of course our capacity and commitment to provide additional support to this community would be decreased, and that would make a fragmented Europe in terms of pricing and enforcement. We will give the opposite of being competitive.”

PSNC seeks Judicial Review of consultation on community pharmacy

PSNC, 1 December 2016

 

PSNC is seeking a Judicial Review of the Secretary of State’s October decision to implement cuts to community pharmacy funding and other changes.

 

PSNC has sought permission from the High Court to apply for the Judicial Review on the grounds that it believes the Secretary of State failed to carry out a lawful consultation on the proposals for community pharmacy.

 

An ‘expedited hearing’ has been requested, so that if permission to seek Judicial Review is granted, the hearing will take place as soon as practicable.

 

PSNC accepts the need for the NHS to achieve efficiencies within the community pharmacy sector and is not challenging this principle, but it does not believe that the consultation process on the proposals that are now being implemented complied with the requirements of a lawful consultation.

 

PSNC believes that the Department of Health (DH) has used poor data which it did not disclose as a basis for its decision, rather than updating existing high quality data.

 

PSNC’s application raises a number of concerns about the consultation, including:

 

  • The DH’s failure to disclose the fact that it had carried out an analysis of pharmacies’ profitability based on Companies House data as part of its Impact Assessment.
  • The delay in providing this analysis to PSNC after the publication of the Impact Assessment.
  • The validity of the DH analysis including the sample size and the use of accounting returns, rather than economic returns, as the basis for the assessment of pharmacies’ economic viability and how they might be affected by the changes.
  • The DH’s failure to analyse what the levels of pharmacy closures may be.

 

PSNC has been taking legal and other expert advice since the letter of December 17th 2015 and in recent weeks working closely with other pharmacy organisations also exploring legal options. The National Pharmacy Association is named as an interested party in PSNC’s application.

 

PSNC Chief Executive Sue Sharpe said:

 

“PSNC’s role is to represent community pharmacy contractors. We have always sought to do this by working positively with the NHS to ensure that community pharmacies can do their best to meet the needs of the NHS, patients and local communities, and that the NHS recognises and acknowledges the value they provide.

 

PSNC has spent the past twelve months trying to work constructively with the Department of Health and NHS England to enable community pharmacy to help the NHS to meet the increasing challenges that it faces. We have sought to avoid taking legal action and very much regret that the process the NHS has followed has made this impossible.”

 

ABPI gives evidence to Exiting the EU Commons Select Committee on Brexit priorities

ABPI, 2 December 2016

 

Dr Virginia Acha, ABPI’s Executive Director of Research, Medical and Innovation has told MPs on the Exiting the European Union (EU) Committee that for the UK pharmaceutical industry a primary objective for Government in Brexit negotiations should be to secure alignment and cooperation with EU medicines regulation.

 

​​The UK is currently part of the European Medicines Agency (EMA), a network that facilitates the harmonisation of medicines regulation for more than 25% of global pharmaceutical market and over 500m patients. This includes EU member states, and non-EU members of the European Economic Area (EEA), Iceland, Liechtenstein and Norway.

 

Robust and internationally aligned medicines regulation, has been essential for protecting and improving the health of patients, has ensured effectiveness and safety, and has brought forward advances in medical innovation to large patient populations in a way that minimises delays and cost.

 

The UK having an aligned framework in place for medicines regulation ‘from day one’ of leaving the EU would be important for maintaining drugs availability and supply.

 

Dr Acha also told the Committee that recently announced Government funding for science and innovation was extremely welcome. In order for this to be maximised, enabling UK researchers and academics to continue global collaboration should be a goal of Brexit negotiations. In line with other leading UK business sectors, she also highlighted that maintaining the ability to trade and move goods and capital across borders, and prioritising ease of movement of global talent for high-value industries, are important for pharmaceutical companies in the UK.​

 

Mike Thompson, ABPI’s Chief Executive commented:

 

“As we lay the foundations for leaving the European Union, last week’s Autumn Statement sent a clear message that a productive high-wage, high-skill economy of the future can be built through investing in UK science and innovation.

 

To make this a reality, maintaining the strength of the UK’s pharmaceutical industry should be a Brexit priority.

 

Government has indicated that they are looking to achieve a bespoke Brexit deal for Britain. As part of this, there are several options for the regulation of medicines. This critical area has a significant impact on the pharmaceutical industry, and we are working with Government to outline the mutual benefit in striking a deal for the benefit of patients in the UK and patients across Europe.

 

UK alignment and cooperation with the EU framework for medicines regulation can be a common goal for our Government and for member states, and should be a priority objective in Brexit negotiations.”

 

​Find out more about our work on what Brexit means for the pharmaceutical industry and our work with Government to maintain and grow of a world-leading Life Sciences environment in the UK outside of the EU.

Pharma companies argue against new UK regulator

Financial Times, David Crow and Gonzalo Viña, 1 December 2016

 

The Financial Times reports that British pharmaceutical companies have been lobbying against the creation of a new regulator in the UK, to replace the European Medicines Agency (EMA). According to a briefing on the negotiations, ministers in favour of a “hard” Brexit are pushing for a British regulator which would decide whether medicines were safe, effective and affordable in a single, streamlined process. The ABPI explained on Wednesday to MPs that the EMA was not a single entity, but a network of co-operation between countries, including countries outside the European Union.

 

The news was also reported by Reuters UK.

 

DH reveals payment scheme for pharmacy urgent supply service

Chemist and Druggist, Grace Lewis, 30 November 2016

 

The Department of Health has announced how much community pharmacies will get paid for providing emergency medication, and in which areas its pilot service will be rolled out first. Those community pharmacies taking part in the programme will be paid a total of £12.50 for any request for urgent medicine received from NHS 111, regardless of whether or not a supply is made, the PSNC confirmed on Tuesday.

 

Review of the year 2016: Brexit

Pharma Times, George Underwood, December 2016

 

Pharma Times discusses the implication of the Brexit vote for the pharma industry in the UK. The negotiations and outcomes are yet to be clarified, creating uncertainty for a number of things including the fate of the European Medicines Agency based in London, the availability of doctors, nurses and health workers and more generally regulation of medicines in the UK.   Mike Thompson, ABPI Chief Executive stated it “creates immediate challenges for future investment, research and jobs in our industry in the UK”.

 

EU drug spending fell after 2008 recession

The Pharmaceutical Journal, Santiago Saez, 30 November 2016

 

Pharmaceutical spending reportedly fell since the financial crisis, combined with an increased disparity in public medicines coverage across the EU. The report by the OECD and the European Commission found that the EU spent more than €200bn on pharmaceuticals, around 17% of its total health spending, making the EU’s third largest expense, after inpatient and outpatient care costs. The report also acknowledges the cost benefits derived from using generic medicines and encourages EU countries to take steps towards using them.

 

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Pharma companies argue against new UK regulator

Financial Times, David Crow and Gonzalo Viña, 1 December 2016

 

The UK pharmaceuticals industry is lobbying against the creation of a British drugs regulator following Brexit, arguing that severing ties with Europe would turn the country into a third-class market.

 

Some ministers — mainly those in favour of a “hard Brexit” — want a brand new UK body, according to two people briefed on the negotiations.

 

This would assess whether medicines are safe and effective to be sold in the UK, and would be combined with Nice, the gatekeeper for drug companies selling to the NHS, these people said.

 

Supporters argue it would offer global pharmaceuticals companies a simpler way of winning approval for their drugs in Britain, because the agency would decide whether medicines were safe, effective and affordable in a single, streamlined process.

 

Currently, drugmakers must get regulatory approval from the European Medicines Agency before negotiating separately over price with Nice.

 

However, the pharma industry, including the largest UK companies GlaxoSmithKline and AstraZeneca, is opposed to the plan. It would prefer the government to come to an arrangement with the EMA, which currently decides whether drugs are safe and effective enough to go on sale in Britain.

 

Virginia Acha, of the Association of the British Pharmaceutical Industry, the lobby group, told MPs on Wednesday that the existing European regulator was not a “monolith” but a “network of co-operation” among countries, including some outside the EU.

 

“There is a precedent there for co-operation,” she told the commons committee on exiting the EU.

 

An industry document provided to ministers ahead of talks in September said a standalone UK regulator would have “significant disadvantages” including “additional regulatory burden” that would “add cost for industry and the UK government”.

 

One person briefed on the talks warned that Britain would fall behind countries such as China and Japan when drugmakers sought approval for their medicines, because it is a relatively small market that tends to drive a hard bargain when setting prices.

 

The UK industry believes it benefits from the European framework because global drugmakers prioritise approval by the EMA, which gives them clearance in all 28 EU countries.

 

Many companies seek a green light from the EMA in tandem with approval by the US Food and Drug Administration, and in some cases go through the European process first.

 

“Increasingly, China and Japan are massive markets, so it would make sense to concentrate on those big clusters before going to the UK,” said one person briefed on the talks. “The risk is the UK falls further down the list and that is not a good development for British patients. It would be a shame and a risk.”

 

David Mowat, a health minister who was against Brexit, told parliament in October that whatever approach the UK takes “it would be disappointing if that happened, and many of us will be working hard to ensure that it does not”.

 

Industry has also said Britain would in effect have to “recognise EU authorisation for the majority of products, aiming to use the same file, same timeline and ensure a quick, pain-free process for industry.” It has also noted “there is no appetite” to find extra money to fund a standalone regulatory framework.

 

GlaxoSmithKline and AstraZeneca are privately opposed to the plans but have avoided putting their concerns on the record for fear of alienating ministers during the negotiations, the people said.

 

DH reveals payment scheme for pharmacy urgent supply service

Chemist and Druggist, Grace Lewis, 30 November 2016

 

The Department of Health (DH) has confirmed how much community pharmacies will get paid for providing emergency medication, and in which areas its pilot service will be rolled out first.

Under the ‘Pharmacy Urgent Care’ pilot programme announced by the DH last month, patients who call NHS 111 for urgent repeat medication will be directed straight to a community pharmacy, instead of an out-of-hours GP surgery.

 

Those community pharmacies taking part in the programme will be paid a total of £12.50 for any request for urgent medicine received from NHS 111, regardless of whether or not a supply is made, the Pharmaceutical Services Negotiating Committee (PSNC) confirmed yesterday (November 29).

 

This consists of a £10 consultation fee and a £2.50 administration fee “to reflect the additional work and documentation required”, PSNC said.

 

A supply fee of £1.50 will be paid for the first item provided, and an additional 50p for each additional item.

 

PSNC said “a phased introduction” of the scheme will take place from December 2016 to March 2017, with the pilot ending in March 2018.

 

The four phases of the roll-out are:

 

Phase 1 – December 2016 – Brighton and Hove clincial commissioning group (CCG); Guildford and Waverley CCG; Blackpool CCG; Fylde and Wyre CCG; Nottingham City CCG; Cambridgeshire and Peterborough CCG

 

Phase 2 – January 2017 – East of England; North East; North West

 

Phase 3 – February 2017 – South East Coast; West Midlands; East Midlands; South West

 

Phase 4 – March 2017 – London; Yorkshire and Humber; South Central; Isle of Wight

 

All contractors in England will be able to sign up to provide the service from tomorrow (December 1) via the NHS Business Services Authority website.

 

However, this sign-up process is only to “register contractors’ intention”, PSNC said. “Most” contractors will not be able to start providing the service immediately, it added.

 

Details not agreed with PSNC

 

When the pilot scheme was first announced, the National Pharmacy Association branded it a “smoke screen… clearly timed to draw attention away” from the cuts to pharmacy funding.

 

PSNC said yesterday that while it supports the commissioning of an emergency supply service “in principle”, the final details of the programme “have not been agreed by PSNC”.

 

“PSNC is pleased to see recognition of how community pharmacies can help patients and the NHS, but we are disappointed that the scheme has only been commissioned as a pilot,” it said.

 

“We are also disappointed that the service will not cover patients who have been referred by other health professionals or come to pharmacies in the first instance themselves.”

 

More expensive than planned?

 

In its initial assessment of the programme’s funding, PSNC said it would be more expensive to run the service than NHS England has suggested.

 

The volume of referrals from NHS 111 to contractors “is likely to be relatively low…based on information provided by NHS England”, it added.

 

“The maximum number of potential referrals is in the region of 200,000 per annum. Based on the experience of similar locally commissioned services, it is unlikely that it will be possible to transfer all of these patient requests to community pharmacy, at least to begin with,” the negotiator said.

 

The lack of funding to provide IT support for the service is “regrettable”, PSNC said, and will incur additional “bureaucracy” and costs for contractors in the long-run.

 

The negotiator suggested the Pharmacy Integration Fund – a £300 million fund designed to assimilate pharmacy into the NHS and other care settings, which is being used to fund this pilot service – should also be used to provide the IT infrastructure needed for the scheme.

 

EU drug spending fell after 2008 recession

The Pharmaceutical Journal, Santiago Saez, 30 November 2016

 

Spending on medicines fell by an average of 1.1% across the EU in the six years following the 2008 financial crisis, finds a report by the OECD and the European Commission.

 

The reductions were “triggered” mainly by cuts in public spending over the 2009–2014 period, the ‘Health at a Glance: Europe 2016’ report says. Some countries saw greater falls than others, such as Greece and Portugal, where drug expenditure fell by more than 7%.

 

In 2014, the EU spent more than €200bn on pharmaceuticals — around 17% of its total health spending. Medicines were the EU’s third largest expense, after inpatient and outpatient care costs.

 

“Pharmaceuticals play a vital role in the health system and policy makers must balance the access of patients to new effective medicines, while providing the right incentives to manufacturers to go on developing new generations of drugs. At the same time, healthcare budgets are limited,” says the report.

 

Thomas Allvin, director for healthcare systems at the European Federation of Pharmaceutical Industries and Associations, the body representing the drug industry in Europe, says that the reduction in medicine sales could be attributed to budget changes of crisis-stricken states.

 

“[R]esource allocation of healthcare budgets must be based on a thorough assessment of the value of different health interventions for patients and societies as a whole”, says Allvin. An investment in medicines can help reduce expensive hospital costs in the same way that prevention measures can help cut treatment costs, he says.

 

The EU spent €402 per capita on medicines, on average, in 2014. However, there were wide differences when individual country spend was analysed. For instance, Germany (€551 per capita) and Ireland (€523) spent more than double that of Denmark (€201) and Estonia (€230). Expenditure per UK citizen was €361. All figures were adjusted for purchasing power in each country and included prescription and over-the-counter drugs but omitted medicines used in hospitals and other healthcare centres.

 

Public cost protection schemes covered about 64% of EU pharmaceutical expenses, but there was disparity in coverage between EU countries. Public coverage of medicines was greater than 80% in some northern and western European states, such as Germany, but lower in countries such as Bulgaria and Cyprus, which paid less than 25% of their citizens’ medicine expenses.

 

The report acknowledges the cost benefits derived from using generic medicines and encourages EU countries to take steps towards using them. The market for these products has grown rapidly since the 2000s. In countries, such as Portugal and Spain, where generic drugs had little or no presence in 2000, generic spending rose to cover more than 40% of the market in 2014.

 

More than 70% of medicines used (in volume terms) in the UK, Germany, the Netherlands and Slovakia were generic in 2014, but these products represented only around 20% of the market in other countries such as Italy and Greece, the report notes.

 

“All EU countries see the development of generic markets as a good opportunity to increase efficiency in pharmaceutical spending, but many do not fully exploit the potential of generics”, says the report.

 

The report presents a wide range of indicators of health and health systems in the EU, including increased life expectancy. Specifically, the report states that life expectancy across the EU has risen by 6 years from an average of 74.2 years in 1990, to around 80.9 years in 2014. However, it notes that there is inequality between western countries with the highest life expectancy, compared with countries in central and eastern Europe, where people die at a younger age.

European medicines regulator sets out plans for revamped drug database

11 October 2016, The Pharmaceutical Journal

 

The European Medicines Agency (EMA) have approved plans for a new electronic database to replace EudraPharm11. It will contain information about all human medicines authorised for use across Europe. The information included on this database will be accessible to the general public as well as healthcare professions. This announcement follows the European pharmacovigilance legislation requiring the creation of an accessible database as part of the EMA’s work to protect public health.

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European medicines regulator sets out plans for revamped drug database

11 October 2016, The Pharmaceutical Journal

 

Plans for an electronic database containing information about all human medicines authorised across Europe, which will be accessible to the public as well as healthcare professionals, have been approved by the European Medicines Agency (EMA).

The medicines safety regulator announced on 7 October 2016 that it has agreed the first steps in developing the web portal, which follows European pharmacovigilance legislation requiring the creation of an accessible database, as part of the EMA’s work to protect public health.

As a starting point, the site will contain all the product data provided to the EMA by drug manufacturers as part of the statutory regulatory process. It will also provide links to similar data held by EU member states’ own national medicines safety regulators.

In a paper adopted by the EMA’s management board on 6 October 2016, the EMA explains that the database, which will be multilingual with search and browse options, will be supplemented with additional validated information as it becomes available.

“The vision for the European medicines web portal is to launch a multilingual website for patients and healthcare professionals, as well as other groups or individuals looking for information and data on medicines, such as academic researchers, providing access to information on nationally and centrally authorised medicines for human use in the EU,” the EMA states, adding that the initiative will enhance the reputation of European medicines regulators as providers of “unbiased, up-to-date, trustworthy, scientifically sound and validated online information on medicines”.

The new website will replace EudraPharm11, a website developed by the EMA in 2006 that sought to provide access to information on medicines authorised in the EU.

Harris confirms bid to house European Medicines Agency

26 September 2016, Irish Independent, Gavin McLoughlin

 

The Irish Minister for Health, Simon Harris, has confirmed that Ireland will be launching a formal bid to become the new host country of the European Medicines Agency (EMA). Speaking at a pharmaceuticals industry conference, Mr Harris announced that his department had already begun laying the groundwork for a formal bid. He believes that it is important for the EMA’s work to face as little disruption as possible when it is relocated from London in the next few years. Officials representing Strasbourg, Lyon, Barcelona, Madrid, Stockholm, Warsaw, Vienna and Milan have already expressed an interest in housing the EMA headquarters. However, the Chief Executive of the Irish Pharmaceutical Healthcare Association, Oliver O’Connor, believes that Ireland has “a strong case” for housing the EMA in the future.

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Harris confirms bid to house European Medicines Agency

26 September 2016, Irish Independent, Gavin McLoughlin

 

Health Minister Simon Harris has confirmed that Ireland will launch a formal bid to house the European Medicines Agency (EMA).

He said attracting the EMA was “one of the more interesting opportunities” afforded by Brexit.

“Given the importance of the EMA’s work…it’s important that any disruption to the agency’s work should be kept to a minimum when it relocates from London, probably within the next couple of years,” Mr Harris said at a pharmaceuticals industry conference in Dublin last week.

“My department…has already begun to lay the groundwork for preparing a formal bid, and I know that your industry will support our efforts to bring this prestigious agency to Dublin,” he added. The EMA is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.

It employs around 900 people, including temporary staff, and is highly sought-after by other EU countries, along with the European Banking Authority (EBA), which is also set to leave London after the Brexit vote. Officials representing Strasbourg, Lyon, Barcelona, and Milan have already expressed interest in the EMA.

Reuters has previously reported that Madrid, Stockholm, Warsaw and Vienna are also in the race to grab one or other organisation in the knowledge that banks and drugmakers will want to maintain close ties with key regulators.

Irish Pharmaceutical Healthcare Association chief executive Oliver O’Connor told the Irish Independent that Ireland had “a strong case” for housing the EMA.

“I think it would be a very good addition to the capability that Ireland has already demonstrated on a global scale for manufacturing, development, and high regulatory standards,” he added.

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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