News

HDA UK MEDIA AND POLITICAL BULLETIN – 27 July 2017

MEDIA SUMMARY 

Patients at risk as UK plans to leave Euratom
European Pharmaceutical Review, Dr Zara Kassam , 26 July 2017

Medics have expressed dismay at UK plans to leave Euratom, saying that it would compromise the ability to easily access medical isotopes. While a limited number of radionucleotide drugs are licensed in the UK, most cancer treatments are dealt with using radiation, which relies on isotopes. Law firm McDermott Law said that while there is some desire to stay within Euratom,  “it will be exceptionally complicated and the UK’s position will inevitably be weakened”. Any agreement to say within Euratom while staying outside of the EU would inevitably lead to complicated transitional arrangements and legal mechanisms to incorporate future Euratom decisions. To deal with this situation, medics and lawyers are recommending that the Department for Brexit appoint a Chief Scientific Advisor, and that the Department of Health should join the Brexit negotiating team.

Young people can contribute to EMA committees for first time
The Pharmaceutical Journal, 26 July 2017

The European Medicines Agency has announced agreed to principles of interaction that allow those under 18 years of age to consult and provide input into EMA regulatory decisions. The EMA said it recognized the importance of giving young people a voice, particularly by “sharing their experience and perspectives of living with a disease or condition”. The views of young people will carried forward on a case-by-case basis, where their views could enhance discussions on pediatric and adolescent treatment. The EMA said that young consultees would likely meet most often with the Paediatric Committee (PDCO). The EMA also said the change was not a revamp of the consultation process, but a way to “enrich the stakeholder engagement process”.

New Chief Commercial Officer appointed
Department of Health, Cabinet Office, 26 July 2017

The Government announced that Steve Oldfield would be appointed the Chief Commercial Officer starting in October. His first task will be to develop a commercial strategy that underpins upcoming negotiations with commercial suppliers and key engagements with the pharmaceutical industry over the PPRS, under which £8 billion is currently spent. Steve has 25 years in the healthcare industry, currently serving as Chief Operating Officer for PGT, a consumer health joint operation between Procter and Gamble and Teva. He has also served on the board of ABPI. He will report directly to the Permanent Under-Secretary.

Westminster Health Forum Keynote Seminar: What now for pharmacy services?
Westminster Forums, 26 July 2017

On 16th January 2018, Westminster Forum will bring together key stakeholders to assess the state of the pharmaceutical industry leading up to Brexit. The Forum will consider the recommendations in the Independent Review of Community Pharmacy Clinical Services and the Pharmacy Integration Fund, as well as future policy initiatives. Speakers will include Ian Strachan, the Chair of the National Pharmacy Association, and Sandra Gidley, Chair of the English Pharmacy Board.The full agenda, with a fuller lineup of speakers, can be found here.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

Patients at risk as UK plans to leave Euratom
European Pharmaceutical Review, Dr Zara Kassam , 26 July 2017

The UK’s proposed withdrawal from the European Atomic Energy Community (Euratom) may threaten the supply of essential medical isotopes, putting cancer patients at risk, according to medics.

UK Prime Minister Theresa May is under pressure to reverse her plan to pull Britain out of Europe’s nuclear regulator after doctors warned that it would jeopardise treatment for cancer patients. The UK does not have the reactors needed to create specific isotopes for complex cancer care and treatment, and is dependent on reactors in France, Germany and Holland.

While a limited number of radionucleotide drugs are licensed in the UK, radioactive isotopes are also used in pharmaceutical analysis and diagnostics. In addition to C14 and H3 isotopes used in DMPk studies, PET (positron emission tomography) studies support a lot of neurological discovery and clinical investigations.

Euratom regulates the nuclear industry across Europe, safeguarding the transport of nuclear materials, disposing of waste, and carrying out research. It also supports the secure and safe supply and use of medical radioisotopes that cannot be stockpiled because they decay quickly.

Concerns have already been expressed by The Royal College of Radiologists and the British Nuclear Medicine Society about the supply of medical isotopes following Brexit, and the risk to patients should supplies be interrupted.

McDermott Law has suggested that the issues regarding the Euratom Treaty are further complicated by legal instruments. Following Brexit, it believes that the UK’s continued membership of the Euratom community would give rise to further complications: (i) the UK government would have to put in place the necessary transitional provisions to ensure that all existing EU instruments relating to Euratom remain in force in the UK, (ii) the UK would have to develop a legal mechanism for incorporating any future regulations or directives relating to Euratom into UK law, and (iii) the UK’s involvement in preparing and negotiating such regulations and directives would be limited.

Professor Martin McKee, of the London School of Hygiene & Tropical Medicine, points out that Euratom “barely featured in the Brexit referendum campaign”, and that government ministers have repeatedly dismissed concerns.

While it may be possible for the UK to remain within existing arrangements, “it will be exceptionally complicated and the UK’s position will inevitably be weakened,” says Prof McKee. Crucially, the government has offered no real clarity as to how any agreement might be achieved, he adds.

“Ministers have no excuse for failing to anticipate this controversy, the problems were highlighted clearly in an article in the Financial Times in February 2017 and in briefings by nuclear industry experts. Yet, as with all aspects of the Brexit negotiations, there is no evidence of any serious planning.”

Prof McKee calls for action on two fronts. First, the Department of Health must be brought into the Brexit negotiating team, as recommended by the Commons Health Committee. Second, the Department for Exiting the EU must urgently appoint a chief scientific advisor, as recommended by the Commons Science and Technology Committee.

Growth Opportunities in the European Next-generation Sequencing Informatics Market‘ details unmet needs and highlights potential opportunities across the secondary analysis, tertiary analysis and storage solution segments.

“As the industry matures, users of NGS informatics services will seek seamless end-to-end genetic solutions in an easy-to-use format at competitive prices,” said Frost & Sullivan Analyst Neelotpal Goswami. “Intensifying demand from pharmaceuticals, biotech, and diagnostic firms will propel NGS informatics providers to develop customised solutions that address user needs – from sample analysis to actionable informatics.”

Trends supporting market development include:

  • Focus on personalised medicine across European nations such as France, Germany, and the UK, along with a number of pan-Europe initiatives
  • National-level genomics data collection and analysis initiatives, such as the UK’s 100,000 Genomes Project and the French Plan for Genomic Medicine 2025
  • Strong research and development and wider application of NGS informatics-based services in Benelux and the Nordics
  • Presence of cutting-edge NGS technology infrastructure in the region, like the Wellcome Trust Sanger Institute, a highly-educated population receptive to NGS technologies and significant government support.

“Europe is a fragmented market, where revenue potential varies significantly in individual countries,” said Mr Goswami. “Additionally, at a pan-European market level, countries have differing regulations and reimbursement practices that may hamper successful commercialisation of NGS informatics solutions. However, innovative approaches such as storing genomic data for analysis within specified geographic borders to match data storage regulations, and evolution in reimbursement policies that increase clarity and coverage for NGS-based tests, will support growth opportunities.”

Young people can contribute to EMA committees for first time
The Pharmaceutical Journal, 26 July 2017
The European Medicines Agency agrees principles for interactions between scientific committees or working parties and young people aged under 18 years.

The European Medicines Agency (EMA) has announced that for the first time patients and consumers aged under 18 will have the opportunity to contribute to the work it does.

The agency has agreed on principles that set out best practice for the interaction between scientific committees or working parties and young people.

The EMA said it recognised the importance of giving young patients and consumers a voice because they “can make an important contribution to EMA’s committee discussions on medicines by sharing their experience and perspectives of living with a disease or condition”.

Its working principles include discussion in small groups, provision of specific support, and use of appropriate language for young people. They also address issues such as obtaining parental consent, protection of personal data, and the privacy of the young patients.

The principles define what input young people could contribute and suggest options on how best to capture their opinions. The document also establishes a process for identifying, supporting and consulting with young people.

According to the guidance, involving young people in the agency’s activities will be considered on a case-by-case basis when it is expected their views could enhance scientific discussions related to developing and assessing medicines for children and adolescents.

The EMA said young people were most likely to work with its Paediatric Committee (PDCO), but it said other of its committees including the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC), and the Scientific Advice Working Party (SAWP) could also benefit from their input.

The agency said that since it was established, it had engaged in dialogue with patients, consumers and carers. “They are involved in almost all areas of the agency’s activities”.

“However, one area where interaction had not yet been established was the option to consult with people under the age of 18.”

The EMA said the new initiative to involve young people in its activities is “not a major revamp of how we look at paediatric medicines, but rather a way of enriching stakeholder input”.

“It complements the work already ongoing in the PDCO and at the agency on this topic, and is an extension of the established engagement methodologies already in place for involving adult patient representatives in EMA’s work,” the EMA said.

New Chief Commercial Officer appointed
Department of Health, Cabinet Office, 26 July 2017 

Government announces new role to streamline commercial costs in the health and pharmaceutical sector.

It is announced today (26 July 2017) that Steve Oldfield will take up the role of Chief Commercial Officer, a newly created position, this coming October.

Steve Oldfield will be joining the Government Commercial Function and taking up a post as the CCO at the Department of Health. His initial focus will be the creation and development of the commercial strategy that will underpin upcoming negotiations with a variety of commercial suppliers, including key engagements with the pharmaceutical industry in particular over the PPRS scheme, under which we presently spend circa £8 billion a year.

Reporting to DH’s Permanent Secretary, Chris Wormald, he will be the most senior commercial manager within the health family and will lead the development of commercial capability and sharing of commercial best practice across the wider health family to the benefit of the whole system. He will be employed centrally as one of the new cohort of senior commercial managers tasked with improving the delivery and cost performance of our supply chain and will report functionally to Gareth Rhys Williams, Government Chief Commercial Officer, and be responsible for ensuring DHplays a leading role in the wider Government Commercial Function.

Steve has more than 25 years’ experience in the healthcare industry. He is currently Chief Operating Officer for PGT, a consumer health joint venture between Procter & Gamble and Teva, based in Geneva. Among his previous roles he has been the UK Managing Director for both Sanofi and Teva, as well as senior roles in Asia and Latin America. Steve has been involved for a number of years with industry-government initiatives, having served on the Board of the ABPI and co-chaired committees looking at the introduction and adoption of new medicines.

Chris Wormald, Permanent Secretary, Department of Health says:

I am delighted that, working with GCF, we have been able to secure Steve Oldfield as our new CCO. We face a number of commercial challenges across the health family, not least putting in place the next generation of the medicines pricing scheme, but we see huge opportunities for better delivery for patients and better value for money for the taxpayers from improved commercial skills and experience.

Paul Baumann, Chief Financial Officer, NHS England says:

Building strong commercial capability is a high priority for NHS England, as we seek to provide access to the best drugs and treatments for patients in a way which secures the best possible value. We welcome this new appointment as part of the department’s initiatives in this area and look forward to close collaboration over the coming years.

Gareth Rhys Williams, Government Chief Commercial Officer says:

As we continue to improve our commercial capability across government, I’m very pleased to have attracted Steve to this key role in Health. He brings deep knowledge of the pharmaceutical industry, which will be very valuable as we start to work with them on the next iteration of the £8 billion per annum medicines pricing scheme.

Steve Oldfield says:

I am delighted to be joining the Department of Health, especially at such an exciting time. Demands on the health system have never been greater, and I hope to be able to bring my previous commercial experience to bear on the activities of the department. In particular, I look forward to working collaboratively across the department, the NHS and the life sciences to find new ways of working for the benefit of patients and the health economy.

HDA UK MEDIA AND POLITICAL BULLETIN – 27 July 2017

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