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HDA Media And Political Bulletin – 11 October 2016

Public wrongly believes cuts are on hold ‘indefinitely’

10 October 2016, Chemist & Druggist, Grace Lewis

 

Stephen Fishwick, Head of Communications at NPA has explained that a number of people still believe the community pharmacy cuts are on hold indefinitely. In September David Mowat, the Pharmacy Minister, announced that the government’s proposed £170 million cuts to pharmacy funding in England would be delayed beyond October. However, following this announcement the Department of Health confirmed that a funding package would be announced in mid-October to be implemented by December. Mr Fishwick explained that the NPA is having  to correct and clarify public understanding on the cuts announcement.

 

Brexit: three months on

October 2016, PharmaTimes Magazine

 

As the initial furore beings to calm down three months after the UK voted for Brexit, the PharmaTimes has re-evaluated what leaving the EU will mean for the UK’s pharmaceutical industry. The current legal framework governing the life sciences industry is largely derived from EU legislation, thus a key post-Brexit concern is what will happen to existing and future marketing authorisations in the UK and the EU. George Freeman, the former Life Sciences Minister founded The UK EU Life Sciences Steering Group to work with key stakeholders to ensure the exit transition is as smooth as possible for the UK pharmaceutical industry.

 

Group calls for radical new approach to UK health

10 October 2016, PharmaTimes, Selina McKee

 

A group of experts is calling for a radical change to the NHS against the backdrop of Brexit. The group notes that the NHS has set out its vision for change in the Five Year Forward View but suggests that the NHS is facing double running costs due to the implementation of new services before eliminating the old. They state that additional funding is needed both to achieve the transformation of the system and to meet the growing needs of an ageing population. They emphasise that a key aim for the UK is to strengthen Britain’s role as a global centre for health and the biomedical and life sciences, following Brexit.

 

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Public wrongly believes cuts are on hold ‘indefinitely’

10 October 2016, Chemist & Druggist, Grace Lewis

 

Many people still believe the cuts to the sector’s funding are on hold “indefinitely”, C+D learned as it joined the National Pharmacy Association (NPA) on the anti-cuts campaign trail last week.

 

While there is “increasing” public and government awareness of the value of community pharmacy, “a lot of people” think the cuts to pharmacy funding are “completely on hold”, the NPA’s head of communications told C+D on Friday (October 7).

 

“We have made it our business to clarify that,” he added.

 

In September, pharmacy minister David Mowat announced that the government’s proposed £170 million cut to pharmacy funding in England is to be delayed beyond October. But just a couple of weeks later, the Department of Health (DH) confirmed in a letter to stakeholders that a funding “package” for community pharmacy in England would be announced in mid-October, to be implemented in December.

 

At the time, NPA chairman Ian Strachan said: “In what sense is a brief negotiation behind closed doors the ongoing dialogue we were promised just days ago?”

 

“Unprecedented” approach

 

Speaking to C+D during a leaflet drop (pictured above) in Burford, Oxfordshire, Mr Fishwick said the public are aware of the NPA’s campaign efforts to fight the funding cuts and ‘Support your local pharmacy’, but “we are having to correct and clarify public understanding on the cuts announcement”.

 

The NPA had a “huge presence” at the party political conferences this year, and the “unprecedented” joined-up approach the pharmacy bodies exhibited this time around helps to keep the anti-cuts campaign – and ongoing support for community pharmacy – in the media, Mr Fishwick added.

 

“We’re in a place right now we have never been before, a place of understanding and support… but unfortunately there are still some officials driving through changes that will put community pharmacy at risk.”

 

Mr Fishwick stressed: “We will continue to talk up the value of community pharmacy and keep the campaign in the public eye, long after the funding package has been announced.”

 

“Wherever the public eye is, wherever the politicians and media are, that’s where we’re trying to be,” he added.

 

Brexit: three months on

October 2016, PharmaTimes Magazine

 

Rules and games

Helen Kimberley and Laura Whiting, Hogan Lovells’ senior associates, and scientific assistant Joseph Wiseman

 

The Life Sciences industry is one of the UK’s leading manufacturing sectors. It is also one of its most highly regulated sectors. The current UK legal framework governing medicines derives largely from EU legislation, and so one of the key post-Brexit concerns is what will happen to existing and future marketing authorisations in the UK and the EU. However, the uncertainty surrounding the future regulatory regime also extends to other important areas including data exclusivity periods, orphan products, supplementary protection certificates, and clinical trials.

 

Marketing authorisation and regulators

 

The MHRA is heavily involved in the granting of Marketing Authorisations (MAs) within the EU. According to its 2015/2016 annual report, it was the Reference Member State for 43 percent of all procedures in which the applicant has sought a UK licence in this period. The MHRA’s influence and expertise, and its central involvement in the EU regulatory process, may be a key selling point for the UK in any negotiations regarding existing MAs and future collaboration.

 

The EMA is also currently located in London and works closely with the MHRA. A number of remaining EU Member States, including Ireland, Sweden and Italy have already expressed an interest in becoming the new home of the EMA. However, relocation to another host country, post-Brexit, is unlikely to be simple due to hundreds of EMA employees being settled in London, its strong symbiotic relationship with the MHRA, and the 25-year lease for its Canary Wharf headquarters that it moved into at the beginning of last year.

 

Meanwhile, The Clinical Trials Regulation, which entered into force on 16 June 2014, is expected to apply across the EU before Brexit takes effect. The UK will need to decide whether to implement equivalent legislation in the UK, post-Brexit, and if so, would need some form of agreement with the EU if it wishes to continue to fully benefit from these new EU Regulations, such as the multicentre approval process.

 

Protection for innovators

 

It seems likely that the UK will continue to protect both developers of innovative medicines and orphan drugs under the data/market exclusivity rules, both to ensure the UK remains equally as attractive as the remaining EU Member States for innovators, and continues to stimulate research and development of medicinal products for rare diseases. Brexit could, however, provide an opportunity for the UK to provide longer protection for innovators or diverge from the EU’s approach in other ways over time.

 

Carrying a maximum of five years’ additional exclusivity at the end of the life of the basic patent, supplementary protection certificates (SPCs) are also considered to be hugely important by innovator companies. As with data exclusivity, if the UK wishes to maintain its commitment to rewarding pharmaceutical research and innovation, it is to be expected that a parallel SPC system would be retained. As SPCs are subject to frequent challenges from the generics industry (which, if successful, allow earlier access to the market), there are likely to be differing views presented by the industry to the UK Government.

 

What can pharma companies do?

 

A newly formed UK EU Life Sciences Steering Group is working with a number of stakeholders across the life sciences industry. The Association of the British Pharmaceutical Industry (ABPI) and the UK BioIndustry Association (BIA) have been working with their members to produce a report setting out its views on Brexit. This was presented to the UK EU Life Sciences Steering Group on 6 September.

 

The MHRA is also working with the UK Government (along with many other stakeholders in the industry) to analyse the opportunities, and its role, in a post-Brexit world. In its response to Brexit, the MHRA makes it clear that continuing a full and active role in regulatory procedures for medicines remains one of its priorities.

 

It isn’t just the UK that is considering the impact of Brexit on the industry. A recent statement by the Japanese Government emphasised the concerns of Japanese companies regarding the relocation of EU agencies which are currently located in the UK, including the EMA.

 

While the preferred Brexit model remains unknown (and the formal process for Brexit has not yet begun), businesses with an interest in the life sciences industry should be thinking about what is important to them. As the UK government continues to gather its Brexit team and develop its strategy, now is the time to be involved. The government is listening.

 

Relocation, relocation, relocation?

Vincenzo Salvatore, member of the Healthcare Focus Team at BonelliErede

 

With the initial shock surrounding Brexit dying down somewhat, it is now the time for pharmaceutical companies to put their thinking caps on and devise a strategy to ensure their future is as bright as possible. It is still difficult to decipher when and how changes will be made, but it is not too early for companies to be considering their options. It is not a matter of standing by and waiting until article 50 is triggered – now that we know that is an inevitability, firms can think about the best business continuity strategies they can be adopting once the UK has separated from the EU.

 

There are initial concerns which the pharma industry needs to tackle: how will European pharma companies do business with. and inside, the UK going forward? And even more importantly, how will these changes affect the wider pharma industry?

 

It is very unlikely that the UK will want to drastically change how things are done with respect to the freedom of movement of medicinal products, from which the UK benefits greatly. The European internal market is extremely convenient for the UK and it is perfectly logical for the UK to want to continue to abide by EU pharma legislation.

 

The first way in which the UK could still benefit from freedom of movement of medicinal products is by going with the Swiss model: EU pharma law does not need to be implemented and the UK would have to make an application to the UK regulatory authorities to be able to sell these goods in the UK – this is something that could have far-reaching implications to businesses so they would need to consider this carefully. The procedures for evaluating medicinal products and granting marketing authorisation for them, as set out by the EU, could not be employed and the UK would have to rejoin the European Free Trade Association.

 

An alternative option for the UK is to join the European Economic Area (EEA) which Norway, Liechtenstein and Iceland are currently part of. This would involve abiding by ECJ case-law in relation to medicinal products, as well as acknowledging all EU administrative decisions. The benefits of adopting this model are numerous: it would mean that pharma firms which are solely based in the UK are able to be a part of a new harmonised procedure for approval of clinical trials taking place throughout the EU, as well as using an EU-wide database to share important information from these trials.

 

Most pressing is the need for UK-based businesses to think about relocating. Pharma companies might want to consider relocating to a country within the EU or the EEA if they do not already have a presence in one of these countries. Pharma companies that may have manufacturing sites of a registered office in the UK are deemed to be in the EU or EEA, as are clinical trials conducted in the UK.

 

For companies conducting clinical trials in the UK, they will need to jump through the hoops of proving that they are complying with standards that are equivalent to those that the EU has in place, otherwise these trials cannot go ahead as they are considered to be taking place in a third country. Relocating could therefore be less of a hassle than staying in the UK.

 

The UK will need to demonstrate the ways in which the pharma industry will be able to operate as seamlessly as possible post-Brexit, which will certainly be a challenge. Issues such as the transferring of patients’ personal data between the UK and the EU will need to be governed differently; for example, exporting active substances to the EU will be subject to the Active Product Ingredient Requirement under the EU Falsified Medicines Directive; and all branches of the UK pharma industry – from clinical trials to marketing – will be governed differently under UK-EU bilateral agreements.

 

The UK faces many challenges ahead with regards to its relationship with the EU, which inevitably has an effect on the pharma industry; losing its membership to European regulatory networks and no longer being part of major decisions that are made regarding rules governing the EU pharma sector are just a couple of the factors which no doubt make the UK a less desirable destination for pharma companies. However, as the uncertainty begins to lift, businesses in the pharma sector can at least go about taking the correct measures to manoeuvre their way through the changing landscape and try to come out of it unscathed.

 

Group calls for radical new approach to UK health

10 October 2016, PharmaTimes, Selina McKee

 

A distinguished group of experts that includes clinicians, scientists, social entrepreneurs and crossbench peers is calling for a radical rethink on health in the UK as the National Health Service “lurches from crisis to crisis” against a backdrop of Brexit.

 

The group has published a manifesto offering a new vision for a healthy and health-creating society in The Lancet, which, building on the policy, insights and actions of many organisations and people throughout the UK and beyond, proposes action across four simple but closely-linked themes.

 

For one, transformation of the health and care system from a hospital-centred and illness-based system to a person-centred and health-based system “needs to be accelerated and funded,” which will require “a massive increase in services in homes and communities and new ways to empower front-line staff, enabled by technology, to manage the complex needs of patients across different services and organisations,” it said.

 

Many different partners and providers will need to get on board with the process but, above all, there must be “far greater engagement of patients and carers in decision making and care, and enabling them to live as independently as possible”.

 

The authors note that NHS England has already set out its vision in the Five Year Forward View, but stress that “implementation is slow everywhere and the system is struggling with maintaining the old services whilst creating the new – and as a result is facing double running costs and failing to invest in the future”.

 

It was also stressed that this transformation will require funding, noting that the UK currently spends about 30–50 percent per capita less on health than, for example, Germany, Sweden, Ireland, Holland, and Australia.

 

“Additional funding is needed both to achieve the transformation of the system and to meet the growing needs of an ageing population. At the same time there is a need to bring together health, social care and, potentially, other local service budgets where this is not already happening for maximum efficiency and impact,” the group said, pointing to a cross-national analysis of the economic impact of spending in differing government sectors that found spending on health “had one of the highest and most positive returns on investment, yielding up to £3 for each £1 invested”.

 

It was also argued that the UK needs to develop and implement a plan for building a health-creating society that addresses health inequalities.

 

Current plans for health promotion and disease prevention are “too small scale and fragmented” to make a lasting impact and the NHS spends very little on the area. “It is clear that developing and supporting a healthy population cannot be done by the NHS, health professionals, and politicians alone. Achieving real impact on the health of people throughout society requires leadership and action from all sectors,” according to the manifesto.

 

It argues that national and local government “have the powers and responsibility to shape the environment and provide incentives for building a health-creating society in every area from employment and housing to welfare support, food, and education – as well as enacting laws and regulations that control the use of tobacco, alcohol, junk foods, and other damaging products and practices”, but also stressed that “business and other organisations have important contributions to make to health as employers, designers, educators, service providers, and manufacturers”.

 

In parallel, health, care, and scientific institutions must help develop and restore a healthy society in the UK, as “a health-creating society can only be built in a society that itself is healthy,” said the group.

 

These communities “embody values of social solidarity and have a crucial part to play in developing and restoring a healthy society in the UK,” and the manifesto stresses that “tackling racism, promoting equality in all its forms, and celebrating innovation and creativity are vital to the sector – and to the country as a whole”.

 

Also a key aim should be to strengthen the UK’s role as a global centre for health and the biomedical and life sciences, which “will require all sectors – the commercial life and biomedical sciences as well as the NHS, academia, government, and voluntary organisations – to build closer and more productive links to achieve synergy and impact”.

 

“Investing in the health and life sciences industries is smart economics. The Wellcome Trust estimated that each £1 investment in cardiovascular disease research produced a stream of benefits equivalent to earning £0·39 per year in perpetuity, easily surpassing the UK government’s minimum threshold of 3·5 pence per pound for investments,” it said.

 

“The NHS faces severe financial constraints and appears to lurch from crisis to crisis, with leaving the EU likely to exacerbate many problems including staffing issues across the whole sector,” note authors of the manifesto, who include former NHS chief executive Lord Nigel Crisp, Lancet editor Richard Horton, and ex chair of the Royal College of General Practitioners Maureen Baker.

 

“However, new scientific developments and digital technology offer societies everywhere massive and unprecedented opportunities for improving health. It is vital for the country that the NHS is able to adopt these discoveries and see them translated into improved patient care and population health, but also that the UK benefits from its capabilities and strengths in these areas.”

HDA Media And Political Bulletin – 11 October 2016

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