HDA UK MEDIA AND POLITICAL BULLETIN – 17 July 2017

MEDIA SUMMARY 

UK drugs regulator looks to partner with Australia, Canada after Brexit
Politico Europe,  Helen Collis, 14 July 2017

The UK medicines regulator (MHRA) is publicly considering an agreement with Australia and Canada to approve new drugs more quickly in all three jurisdictions. The plan would mean that a product that was approved in the UK would automatically gain market access in Canada and Australia. Andrew Gregory, deputy policy at the MHRA said that “we’re looking at what’s attractive for smaller markets, globally it will give us an opportunity to collaborate around the world”. These countries are already working on a ‘decentralized procedure’, meaning only one country would assess the drug. Given that the UK is likely to leave the EMA, the collaboration could be seen as a full-court press to ensure that regulatory cooperation continues across markets.

Disappointment as government delays pharma-friendly policies
Pharmaphorum, Richard Staines, 14 July 2017

The government’s Accelerated Access Review (AAR) has fallen short of expectations, with the NHS continuing to be slow in adopting new technologies and medicines. The AAR, originally designed to stimulate the life sciences sector and encourage the use novel drugs, was said to have the potential to reduce the drug approval process by four years. However, the government has yet to respond to the AAR, and funding for the life sciences has been withheld. The head of commercial policy at the ABPI, Richard Torbett, urged the government to act, calling for a “full, positive government response”. So far, the feeling in the industry is one of ‘overwhelming disappointment’.

How the NHS became embroiled in a global drugs price clash
The Daily Telegraph, Iain Withers, 16 July 2017

The recent lawsuit filed by the ABPI on behalf of multinational drug firms is simply “a proxy battle in a long-running tussle between global pharmaceutical firms and the NHS over drug-pricing”. While the ABPI launched the lawsuit, the Telegraph notes that it has “failed to show a united front” with British members of the group, including GSK and AstraZeneca, refusing to publicly endorse the lawsuit. While the ABPI represents over 60,000 strong pharmaceutical sector, 14 of 16 of its board members represent foreign-owned companies. A source close to the situation said “there’s a strong correlation between the level of long term and strategic investment in the UK and feeling on the judicial review”. Michael Cooper, a pharmacy equity analyst, said that tensions over prices run deep and are only set to get worse.

Big pharma is taking the NHS to court this week – people are already dying for profit and it could now get worse
The Independent, Morten Thaysen, 12 July 2017

The Independent weighed in on the current drug pricing disagreement, saying the root cause is the “greed of pharmaceutical companies”. Calling the price rises “skyrocketing”, the author noted that while austerity and refusing to fund the NHS was a problem, all drug companies “spend more on marketing than they do on research”. The author argued, instead of a price cap, the government should “take back control of health technology” – advocating more government intervention in a market with already small profit margins.

How ‘no deal’ could bring Britain to a halt
The Financial Times, Chris Giles, 16 July 2017

In a wide-ranging article on the impacts of a ‘hard brexit’, the Financial Times reserved a mention to the drug sector, saying that medical licensing is the most salient problem in this sector. In the ABPI’s words, the problem is a large one: “This is not like transferring a filing cabinet from one location to another . . . This will take time and investment”.

Parliamentary Coverage

UK BioIndustry Association – Lord O’Shaughnessy outlines government’s plans for post Brexit landscape for UK life sciences at BIA/MHRA Conference
July 14, 2017

Lord O’Shaughnessy, Life Sciences Minister, has publicly expressed the government’s support for the life sciences industry. He outlined three principles for any collaboration with the EU and internationally: patients must never be disadvantaged, the UK must continue to play a leading role in public health, and businesses must be able to get their products to the market as quickly as possible. The BioIndustry Association, the organization at which the minister made these remarks was publicly supportive, saying that it was a “clear message” of support to the industry.

Full Coverage

 

Disappointment as government delays pharma-friendly policies
Pharmaphorum, Richard Staines, 14 July 2017

The government’s Accelerated Access Review (AAR) was supposed to herald a new age of innovation in the NHS, cutting drug development times and encouraging the use of novel medicines and treatments.

But a new set of policies from the government has fallen short of the ambitions of former life sciences minister, George Freeman, who began the Accelerated Access Review back in 2014.

The government has admitted it has delayed many of the policies that pharma hoped would encourage the NHS to use more novel drugs, and stimulate the life sciences industry.

While the NHS held on to top place in an analysis of safety and affordability by the Commonwealth Fund think tank today, the health service has long been criticised for failing to adopt new technologies and medicines.

Authored by top civil servant Sir Hugh Taylor, the AAR was published last October and outlined ambitious plans based on a lengthy and thorough national consultation.

Proposals included a revamped approval process that could cut the drug development process by up to four years.

The review envisioned a partnership between NHS England, NHS Improvement, NICE and the Medicines and Healthcare Products Regulatory Agency (MHRA) regulator to streamline the development process.

Taylor also proposed a national “Accelerated Access Pathway” for the most transformative products and stronger incentives for NHS organisations to use and spread the benefits of innovation.

While many in the life sciences industry are publicly congratulating the government on the initiative, the overwhelming feeling is that of disappointment.

Freeman never got the chance to see the review to its conclusion, after the life sciences minister job disappeared following a reshuffle when Theresa May took charge as prime minister last year.

Instead of the “joined up” life sciences policy promised by the original document, the government has decided to give out a total of £86 million to four key projects.

Academic Health Science Networks will get £39 million, enabling them to assess new health technologies and “support NHS uptake.”

A £35 million Digital Health Technology Catalyst will match fund development of such technologies for the NHS.

There will also be £6 million over the next three years to support development of drugs by small and medium-sized enterprises.

And a £6 million Pathway Transformation Fund will help NHS organisations integrate new technologies into everyday practices.

Speaking at the joint MHRA-BioIndustry Association in London, junior health minister Lord O’Shaughnessy said that plans to improve uptake of medicines in the NHS will be included in AAR funding, but this cash has been delayed because the government wants the review to be as ambitious and transformative as possible.

The government has also not responded formally to the AAR and its recommendations. “Our response to the AAR has hardly been accelerated itself,” he admitted at the conference in London, although he said that the government plans to publish the response.

He also dodged a question on when a new industrial strategy – possibly including other pharma-friendly policies – will be published.

Lord O’Shaughnessy did try and reassure the conference that whatever happens with Brexit, patients will not lose out in terms of speed of access to drugs as the country leaves the European Medicines Agency and the regulator moves away from its London headquarters.

The Association of the British Pharmaceutical Industry (ABPI) stopped short of publicly criticising the government, noting that the Academic Health Science Networks are a “critical delivery partner” for the review.

But Richard Torbett executive director of commercial policy at the ABPI urged the government to act on the proposals in the rest of the report.

He said: “Turning the rest of the AAR’s recommendations into reality now relies on a full, positive government response to the Review – and an effective life sciences industrial strategy.”

“If we get this right, fostering greater collaboration between innovators, patients, NICE and the NHS can make the UK the world leading hub for Life Sciences.”

Big pharma is taking the NHS to court this week – people are already dying for profit and it could now get worse
The Independent, Morten Thaysen, 12 July 2017

The UK drug industry is taking the NHS to court over a new price cap on medicines. The drugs price cap is a disaster for patients, but the solution is not taking the NHS to court – it’s tackling the greed of big pharmaceutical companies.

The pharmaceutical industry has established itself firmly at the top of the Forbes list of the most profitable industries in the world. A significant contribution is made by public health services like the NHS. But seemingly, that’s not enough. The Association of the British Pharmaceutical Industry has applied for a judicial reviewagainst the NHS over its attempt to protect its crumbling budgets from corporate rip-off.

The knowledge that the treatment you need exists, but isn’t available to you, is a more common experience in the UK, as the NHS has to resort to rationing and even straight out rejection of new drugs because they’re too expensive.

The NHS now rejects a third of all new cancer drugs over cost-efficiency concerns, leaving many cancer patients unable to access the treatment they need. And because of astronomical costs, the NHS has had to ration a new groundbreaking cure for hepatitis C to only the very worst cases of more than 200,000 people, leaving the vast majority to continue to suffer from the disease.

Many are quick to point the finger at the NHS over lack of access to medicines. But the fact of the matter is that rising drug prices, together with austerity measures, are destroying our health service. The rise in NHS drug costs in the last five years has now hit more than twice the entire NHS deficit of £1.85bn. It’s because of these skyrocketing drug prices that the NHS took the decision to place a price cap on new drugs earlier this year, allowing them to delay the introduction of new drugs that would cost more than £20m pounds a year.

If we want to secure better access to medicines, we must tackle the problem of high drug prices, and this means transforming the whole way new drugs are developed. Pharmaceutical companies argue that high prices are due to research and development costs. But almost all of the biggest pharmaceutical companies spend substantially more money on marketing than they do on research.

Last year Gilead, the American pharmaceutical giant behind the above-mentioned hepatitis C cure, boasted a 45 per cent net profit margin – which would be unheard of in most industries – while almost 400,000 people died of the now curable disease globally.

This gives some idea of the extent of the problem globally. Imagine the impact on people in countries which don’t even have accessible health systems. The pharmaceutical industry has proved time again they cannot be trusted with the control of vital medicines we need. If we want access to new medical treatments, we need to rethink the way they are controlled.

The UK pours huge sums of money into medical research and development. Globally, taxpayers are the biggest funders of early-stage medical research. But because of few or no conditions of our research, pharmaceutical companies can take over that research and market the resulting drugs at considerable profits. The only way to heal the gaping hole drug prices have cut in NHS finances, it to make sure that we at least demand affordable prices from the drugs that are developed with our tax money.

For the sake of our NHS – and for the billions of people globally who cannot access the medicines they need – we must take back control of the health technology that our tax money is paying for. If we’re lucky, we end up paying twice for our medicines. If we’re unlucky, the consequences are even worse.

There are alternatives, which mean that the private corporations don’t gain intellectual property privileges gained through public funding. Our NHS demands a different answer – one that puts people ahead of profit
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UK BioIndustry Association – Lord O’Shaughnessy outlines government’s plans for post Brexit landscape for UK life sciences at BIA/MHRA Conference
July 14, 2017

Lord O’Shaughnessy, Parliamentary Under Secretary of State for Health, has underlined the government’s commitment to support and promote UK life sciences in the ongoing Brexit negotiations with the EU at the BIA MHRA conference today. This is the first speech by a government minister that publicly addresses industry concerns and commits government to working with the sector throughout the negotiation process.

The minister emphasised the government’s vision for future collaboration between the UK and the EU, and emphasised that the UK is a ‘scientific, regulatory and industrial centre of excellence,’ and outlined three key principles that must underpin any future relationship with the EU:

• First: patients must never be disadvantaged;
• Second: the UK will continue to play a leading role promoting and ensuring public health – both in Europe and around the world; and
• Third: industry must be able to get their products into the UK market as quickly and simply as possible, with the UK and Europe at the forefront of medical innovation.

BIA CEO, Steve Bates, said: “It’s great to see that the minister has taken the opportunity at the joint BIA MHRA Conference, to offer a clear message to the UK life sciences industry, as we look towards the next round of EU negotiations taking place next week. The strong commitment ‘to secure ongoing close collaboration between the UK and the EU, with the needs and rights of patients always our paramount concern’ is good news for patients, industry and investors in the UK and EU.

“This builds on the helpful letter from Secretaries of State Jeremy Hunt and Greg Clark last week. The BIA will continue to share our members’ expertise with government and all relevant stakeholders throughout the negotiation process and continue the ‘positive level of engagement and debate’ that has occurred so far between us.”

-Ends

MEDIA SUMMARY 

EU Pharma Bosses warn of Brexit medicines threat
Financial Times, Sarah Neville, 13 July 2017

The Financial Times has reported that EU pharma bosses have warned against a “disorderly Brexit”, following on from the joint ABPI-EU letter to Michel Barnier and David Davis. The FT calls it the ‘first coordinated response’ from the pharmaceutical industry about the potential impact on Brexit. All the associations warned against ‘severe disruptions’. The CEO of the ABPI, Mike Thompson, said that the desired goal would be ‘frictionless trade’ between the EU and the UK facilitated, once the 2 year negotiating period is complete, by a common standard of regulations.

EU & UK pharma leaders write to Brexit negotiators
PharmaTimes, Selina McKee, 13 July 2017

PharmaTimes called the letter to Michel Barnier and David Davis an ‘unprecedented move’. PharmaTimes commented that it is clear that “close cooperation should be the ongoing priority” in negotiations. The letter noted that the current system is maintained“through a sophisticated system of legal and regulatory arrangements” that would require cooperation to be maintained. The letter further stated that the Medical and Healthcare products Regulatory Agency (MHRA) played a vital role and that any loss of cooperation would lead to a ‘loss of capacity’ in the UK and the EU.

Brexit Health Alliance welcomes collaborative EU relationship
European Pharmaceutical Review, Niamh Marriott, 13 July 2017

Responding to the previous commitment from Health Secretary Jeremy Hunt and Business Secretary Greg Clark, to cooperate with the EU on matters of medical and pharmaceutical regulation, the Co-Chair of the Brexit Health Alliance Niall Dickson said it was a ‘very welcome signal’. He called the determination to cooperate necessary, saying “we must maintain the highest possible level of collaboration and regulatory alignment.” The Brexit Health Alliance brings together stakeholders from the NHS, research, public health organizations and patient associations to advocate for changes in light of Brexit.

Parliamentary Coverage

There is no parliamentary coverage.

Full Coverage

Davis proposes transition period for EU agencies in UK after Brexit
Politico Europe,  Helen Collis, 13 July 2017

LONDON — The U.K. wants to grant EU organizations and agencies “privileges and immunities” to continue operating in the U.K. for a certain period of time after Brexit — opening the door to a transition period for the European Medicines Agency and the European Banking Authority to relocate from London.

“These privileges and immunities should reflect the extent of the U.K.’s continued involvement in any EU programs, agencies or other activities,” stated one of several briefing papers issued Thursday by the Department for Exiting the European Union.

The U.K. would grant these for international organizations “primarily on the grounds of functional need.”

This is as per international law, the government argued, and also recognized in Protocol 7 of the Treaty of the Functioning of the European Union.

Europe’s life sciences sector has raised serious concerns over the timeframe for Brexit. In a letter to chief Brexit negotiators David Davis and Michel Barnier on Wednesday, eight trade groups urged them to consider continued cooperation of medicines regulations as soon as possible, given public health concerns and the extent of the extra workload for the industry and the regulators.

A transition period would ease these pressures.

The government said these privileges and immunities would “apply for a limited period after exit, in order to permit the EU a reasonable time in which to wind up its current operations in the U.K.”

“The scope and duration of such a transitional period may be different for different types of asset or agency,” the briefing paper says.

Davis’ department aims to start these talks as soon as possible.

EU & UK pharma leaders write to Brexit negotiators
PharmaTimes, Selina McKee, 13 July 2017

In an unprecedented move, eight leaders from associations representing the entire EU and UK pharmaceutical sector have written a joint letter to chief Brexit negotiators Michel Barnier and David Davis requesting that ongoing cooperation between the two territories for medicines be a negotiating priority.

Securing an agreement between the EU and UK “is the best way of ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines and to ensure that there is no adverse impact on public health,” the letter states.

The industry is highly integrated across Europe and regulated under EU law “through a sophisticated system of legal and regulatory arrangements between EU institutions, Member States and national competent authorities,” it notes, adding: “It is important that there is as much certainty as possible, as early as possible, to enable the pharmaceutical and life science industry to transition smoothly into the new framework, ensuring there is no disruption to patient access to medicines”.

The leaders call for the maintenance of previously granted European marketing authorisations both in the UK and the EU and continued cooperation between national authorities as facilitated by the European Medicines Agency and European Commission, and also stress that any changes to the EU-UK trading relationship “should not adversely affect the research, development, manufacture and supply of medicines across Europe, including for clinical trials.”

They also note that the UK’s MHRA currently makes “a significant contribution” to the work of the European regulatory network, and argue that there its withdrawal “would mean a loss of capacity and expertise for the network for the review of medicines as well as the capacity across Europe for the surveillance and safety supervision of products.”

The letter warns that, in the case of an “unorderly withdrawal”, there is a risk that all goods due to be moved between the UK and EU could be held either at border checks or in warehouses subject to extensive retesting requirements. “This would lead to a severe disruption of most companies’ supply chains, which would lead to potential supply disruptions of life-saving medicines.”

​An implementation period should also be agreed on by negotiators to allow pharmaceutical and biotech companies to transition to a new framework and “avoid any unintended consequences on the availability of the medicines.”

The move follows a letter published in the Financial Times last week​ by Jeremy Hunt, Secretary of State for Health, and Greg Clark, Secretary of State for Business, which said the UK “would like to find a way to continue to collaborate with the EU, in the interests of public health and safety” post Brexit.

Brexit Health Alliance welcomes collaborative EU relationship
European Pharmaceutical Review, Niamh Marriott, 13 July 2017

Niall Dickson responds to the commitment by the secretaries of state to seek a collaborative relationship with the EU in medicines regulation and supply…

Responding to the commitment by secretaries of state Jeremy Hunt and Greg Clark to seek a collaborative relationship with the EU in trade, medicines regulation and supply, Niall Dickson, co chair of the Brexit Health Alliance, said:

“This is a really important and welcome signal. If we get these negotiations wrong, there is a real danger that patients could be denied access to cutting edge treatments, and indeed access to a wide range of innovative health technologies. The determination of the UK government to continue with a regulatory system that protects and supports the life science sector is very welcome.

“The current EU medicines research, development and regulatory arrangements work well and benefit from the input of UK academics, regulators and industry. For patients in the UK and across Europe we must maintain the highest possible level of collaboration and regulatory alignment.”

About the alliance

The Brexit Health Alliance brings together the NHS, medical research, industry, patients and public health organisations to safeguard the interests of patients and the healthcare and research they rely on.

The Brexit Health Alliance will complement the work of the Cavendish Coalition, which is concerned with the staffing and workforce implications in health and social care of the UK leaving the EU. The Cavendish Coalition is led by NHS Employers, which is part of the NHS Confederation.

Founding members of the Brexit Health Alliance are NHS Confederation – Co-chair of alliance, Welsh NHS Confederation, Northern Ireland Confederation (NICON), Association of UK University Hospitals (AUKUH), Academy of Medical Royal Colleges (AOMRC), NHS Providers, National Voices, Association of the British Pharmaceutical Industry (ABPI), Association of British Healthcare Industries (ABHI), The Richmond Group of Charities, BioIndustry Association (BIA), Faculty of Public Health (FPH), Association of Medical Research Charities (AMRC), and Scottish NHS Chief Executive Group.

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