News

HDA UK Media And Political Bulletin – 25 January 2017

Media Summary

Brexit Could Put The UK ‘Second Rank’ For Access To New Medicines

Huffington Post UK, Martha Gill, 24 January 2017

Health Secretary Jeremy Hunt told MPs this week that patients could face significant delays for new medicines as a result of Brexit. Saying that Britain would leave the European Medicines Agency (EMA), Hunt confirmed that this could leave it ‘second rank’ in terms of accessing new drugs, lagging behind the EU and the US. The EMA offers a quick route for marketing medicines across the EU, allowing major drug companies to bypass regulators in individual member states. MPs opposed the Health Secretary for ceding membership of the EMA so quickly. Hunt said he would fight for the ‘closest possible equivalence’ to the UK’s existing relationship with the EMA in Brexit negotiations, where there will be a number of organisations and agencies to navigate. Theresa May, too, has pledged to champion the UK’s pharmaceutical industry, saying in July that it was ‘hard to think of an industry of greater strategic importance to Britain that its pharmaceutical industry’.

Life Sciences Leaders Welcome UKs Industrial Strategy

Pharma Times, Selina McKee, 24 January 2017

Life sciences leaders have welcomed the government’s new industrial strategy, which places science and innovation at the centre of plans for post-Brexit Britain. Prime minister Theresa May said that the new strategy supports ‘creating the conditions where  successful businesses can emerge and grow, and backing them to invest in the long-term future of Britain’. Additionally, the government will invest £4.7 billion by 2020/21 in R&D funding – a bigger increase than in any Parliament since 1979. Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, welcomed the plan, with the appraisal that ‘[o]ur sector is worth £60bn a year to our economy, employing more than 220,000 highly skilled people across the UK. If we play to our strengths, we can go even further and create one of the world’s pre-eminent hubs for life sciences research and investment’.

2016 GMP Symposium

MHRA Inspectorate, Michelle Rowson, 24 January 2017

The 2016 MHRA Symposium put a spotlight on good manufacturing practice. Updating delegates on current activities, it also reassured that no routine activities have been put on hold because of Brexit. Planned updates to the EU GMP were outlined and international coalition initiatives were discussed, such as the International Coalition of Medicines Regulatory Agencies (ICMRA) and the EU/USA Mutual Reliance Initiative (MRI). The MRI is a strategic collaboration between EU regulatory authorities and the US-FDA to evaluate whether there are comparable regulatory frameworks for inspections of manufacturers of human medicines. Current plans are for the initiative to enter into operation later in 2017. The Symposium closed with Richard Andrews reminding delegates of the key themes of the day:

  • Organisations need to maintain awareness of GMP requirements and ensure there are systems in place to identify new requirements and implement the required changes within the pharmaceutical quality system.
  • Organisations need to consider the impact of company culture and management behaviour – the data integrity, IAG/CMT, deficiency data and investigation of anomalies presentations all identified company culture as being a key factor in improving GMP compliance
  • MHRA has, and plans to maintain a key role in EU and International initiatives.

Parliamentary Coverage

There is no Parliamentary coverage.

Full Coverage

Brexit Could Put The UK ‘Second Rank’ For Access To New Medicines

Huffington Post UK, Martha Gill, 24 January 2017

Patients could face a delay of up to a year for new medicines as a result of Brexit, the Heath Secretary told MPs on Tuesday.

Jeremy Hunt said Britain would leave the European Medicines Agency (EMA), a regulator, and confirmed this could reduce it to “second rank” in terms of access to new drugs, behind the EU and the US.

Major drugs companies, including those for cancer, use the EMA as a quick route to marketing medicines across the EU, as they can then bypass regulators in individual member states.

Hunt told the Health Select Committee it was also “likely” the regulator’s headquarters would move out of the UK, where it employs 890 people.

MPs slammed the Health Secretary for giving up membership of the EMA “without a fight”.

“It’s vital for the whole of the functioning of our medicines industry… We seem to be giving up this one without a fight,” Labour’s former health minister Ben Bradshaw said. Theresa May has pledged to champion the UK’s role in drug research and development. In July she said it was “hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry.”

The EMA has been based in London for two decades, cementing the UK’s place in Europe’s drugs industry.

But on Tuesday Hunt told MPs he did “not expect” to remain within the EMA, although he was “very hopeful” to keep working “very very closely” with the regulator. He agreed with warnings from SNP MP and former surgeon Philippa Whitford that the UK might move into the “second rank” for access to drugs if it couldn’t maintain its relationship with the EMA.

“We might move into the second rank for drugs being launched, in that Canada and Australia get access to new drugs six months to a year behind the EU and the US, and that’s just market size”, Whitfield said.

“That is precisely why I would like to have the closest possible relationship, and would also say that I think the EU has as much to gain as we do from having that close relationship because of the scientific expertise within this country”, Hunt said in reply.

But MPs criticised Hunt for not trying harder to retain membership of the EMA. “I have real concerns… that pharma are simply going to see the UK as a hostile market. It’s not just that we’ll be down there with Canada and Australia, six months to a year behind, we could slide further down”, Whitford said.

“We don’t want research that is done here that eventually becomes a drug, doesn’t become available.” “We’ve just had a meeting with one of your colleagues who says the UK will retain membership of the European Patent Office. There are all sorts of agencies and organisations that are vital for us to remain a member of”, Bradshaw said.

“We seem to have given up on this one.” Hunt said he would be arguing for the “closest possible equivalence” to the UK’s existing relationship with the EMA the upcoming Brexit negotiations.

The Department of Health and the Association of the British Pharmaceutical Industry have agreed in principle to amend Chapter 6 of the 2014 PPRS in accordance with paragraph 3.4 of the scheme in order that the scheme continues to deliver its agreed objectives of predictability and stability to Government and industry, and ensuring that the cost of branded medicines to the NHS stays within affordable limits. The effect of the changes is that the payment percentage for 2017 is to be set at 4.75% for 2017, and the 2018 PPRS payment percentage will be determined by reference to the existing PPRS payment mechanism, provided that the resulting percentage falls within the lower and upper limits of 2.38% and 7.80%. The Government recognises the additional contribution being made by the pharmaceutical industry in acknowledgement of the financial challenges facing the NHS.

The Department has published a document setting out further details entitled “Pharmaceutical Price Regulation Scheme (PPRS) 2014: revised payment percentages at December 2016”. A copy is attached.

Life Sciences Leaders Welcome UKs Industrial Strategy

Pharma Times, Selina McKee, 24 January 2017

Life sciences leaders have welcomed the government’s new industrial strategy, which gives science and innovation a prominent role in plans for post-Brexit Britain. According to prime minister Theresa May, the new strategy is designed to help “deliver a stronger economy and a fairer society”, “creating the conditions where successful businesses can emerge and grow, and backing them to invest in the long-term future of Britain”.

“Our action will help ensure young people develop the skills they need to do the high-paid, high-skilled jobs of the future. That means boosting technical education and ensuring we extend the same opportunity and respect we give university graduates to those people who pursue technical routes,” she said.

The green paper outlines proposals to further encourage pupils to study STEM (Science, Technology, Engineering, Maths) subjects and explore options to incentivise growth in the number of STEM graduates, as well as a commitment for more apprenticeships and PhD funding. Also, as previously announced, the government will invest an additional £4.7 billion by 2020/21 in R&D funding, a bigger increase than in any Parliament since 1979, to help bring the UK’s spend in the area more in line with European peers.

There is now consultation on how to invest this funding, setting out options ranging from investment in local science and innovation strengths, and increased support for commercialisation, to investing in future research talent, May noted. Chris Stirling, KPMG’s global lead for life sciences, said he expects that this funding and support “will focus on encouraging companies, particularly smaller businesses, to be more innovative and to make better use of technology developments including artificial intelligence and robotics”.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, has welcomed the plans. A successful industrial strategy “will help deliver a strong pharmaceutical industry for the UK economy and improve healthcare for patients,” he said. “Our sector is worth £60bn a year to our economy, employing more than 220,000 highly skilled people across the UK. If we play to our strengths, we can go even further and create one of the world’s pre-eminent hubs for life sciences research and investment”.

Also responding to the paper’s launch, Steve Bates, chief executive of the BioIndustry Association, said: “It’s great to see life sciences at the heart of the government consultation on Industrial Strategy. They are right to focus on investing in science research and innovation, developing skills, supporting business to start and grow, and cultivating world leading UK sectors like biotech”.

“The Industrial Strategy should capitalise on the UK’s strong fundamentals that underpin our vision and help attract investment to the UK, stimulate the growth of our domestic industry, deliver effective and efficient healthcare for future generations, seize the opportunity of the UK’s lead in efficient and effective regulation of new technologies and demonstrate that the UK is open for business.”

Brexit uncertainty
However, Stirling stressed that since the Brexit vote, there remains “plenty of uncertainty” in the industry.

“UK participation in EU research and development programmes is at risk, and scientists and other skilled workers from the EU are considering returning to their home countries. The regulatory environment is also likely to be significantly more complex as, currently, the UK relies significantly on the European Medicines Authority (likely to be moving out of London).

“These issues are still very real for the industry, but its businesses will hope [the] commitment by May will soften the potential blow.”

 

2016 GMP Symposium

MHRA Inspectorate, Michelle Rowson, 24 January 2017

It was a case of “lights, camera, action!” for the GMP days of the 2016 MHRA Symposium, with speakers making use of video clips, music, and pictures in order to deliver key messages.

As the GMDP Operations Manager with overall responsibility for planning and delivery of the event, I am pleased to be able to share with you some of the highlights of what was a professional and well received event.

The Inspectorate have taken to heart one of the MHRA’s priorities of supporting innovation and applied this to ensure the symposium was keeping up to date with emerging technologies. As well as a number of new presenters taking to the stage this year, the event made use of the MHRA Event App for the first time. The app enabled delegates to access presentation materials and to participate in the interactive sessions using their own electronic device.

The GMP day started with an opening presentation by Richard Andrews (Unit Manager Inspectorate Operations GMP and PV), who provided an update on applicable Agency, International and Inspectorate activities. This included confirmation that the 2017 editions of both the Orange Guide and Green Guide are on track to be published in January 2017 and also confirmation that no routine activities have been put on hold as a result of Brexit. George Collins (GMDP Inspector) then took to the stage to provide a regulatory update, which covered recent changes now in effect, and on-going and planned updates to EU GMP, Q&As and guidance for industry. George played the role of anchor man in delivering the regulatory news and was supported by video pop-ups from subject matter experts, who provided more detailed update reports. The following diagram provides a timeline of past and future changes in the pipeline.

The take home message was that the structure of GMP is changing. The EU Commission has taken a new approach to publication of specialist guidance. Organisations that manufacture a

combination of authorised products, IMPs and ATMPs will need to implement a quality system which accommodates the requirements of separate GMP guidances.

Mark Birse (Group Manager Inspectorate) then provided an update on current international coalition initiatives, which included updates on the various Pharmaceutical Inspection Co-operation Scheme (PIC/S) activities MHRA is leading and supporting, the International Coalition of Medicines Regulatory Agencies (ICMRA) and the EU/USA Mutual Reliance Initiative (MRI).

Mark explained that the ICMRA project aims to determine if it is feasible to take a risk-based approach to international inspections, placing reliance on data provided by the site and by their national regulator to carry out desktop assessments rather than inspecting the site.  The phase 1 implementation has now been completed and phase 2  will be starting in Jan 2017 to expand the number of countries involved. The proposal longer-term is for the operational phase to be transferred to PIC/S.

The MRI is a strategic collaboration between EU regulatory authorities and the US-FDA to evaluate whether we have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines so that we can rely on each other’s information. The FDA is continuing to assess each EU regulator.  The UK assessment has been finalised and the decision is now awaiting ratification.  The current proposal is that the initiative will be ‘signed off’ in January 2017, and enter into operation later in 2017 on a voluntary basis for inspections carried out in member territories, with a view to making it a permanent requirement in 2019.

The agenda then moved to an interactive session taking another look at data integrity, and explored why we are still seeing stories in the media relating to data governance and data integrity failures at manufacturing sites, despite the publication of MHRA and international guidance for industry. This thought provoking session was presented by Graham Carroll (GMDP Inspector) and David Churchward (Expert GMDP Inspector), who concluded that effective implementation of data governance requires understanding of organisational behaviour, business process, data lifecycle, data risk, and critical thinking.

The next session provided an overview of the processes and possible outcomes of the Inspection Action Group (IAG) and Compliance Management Team (CMT) activities. Alan Moon (GMDP Inspector) and Andrew Hopkins (Expert GMDP Inspector) presented the session, which emphasised that the primary function of the two escalation processes is to protect the patient. An interactive poll of delegates revealed that over 70% were unaware of the CMT, which is a non-statutory process managed within the Inspectorate by Senior and Expert Inspectors, Operations and Unit Managers. The process was introduced by the GMP Inspectorate in late 2013/early 2014, with the aim to help direct companies back into a state of acceptable compliance, maintain supply of medicines, and avoid regulatory action.

Vivian Rowland (GMDP Inspector) then provided an update on deficiency data trending for 2015 and 2016 and presented examples from the most cited deficiency topic areas. To highlight one area of international collaboration the Inspectorate is involved with, Vivian provided some background to the work of the PIC/S working Group on Harmonisation of Classification of Deficiencies and the development of a tool for Inspectorates to improve harmonised risk classification of GMP deficiencies. It was reassuring to see that of the top ten most cited deficiencies across PIC/S countries, eight of the ten were the same as those within MHRA’s top ten of most citied deficiencies.

Quality Systems was the number one most cited deficiency by both MHRA and PIC/S countries, with a particular weakness noted in the investigation and reporting of quality incidents,

deviations, customer complaints, out of specification investigations. It was therefore very timely that the next session on the agenda focused on the investigation of anomalies. Delegates were given the opportunity to benefit from some “tricks of the trade”, as Ewan Norton (GMDP Inspector) demonstrated some excellent practical tips on how to improve the effectiveness of investigations, to identify common causes of error and ensure effective CAPA is implemented.

This year’s event also featured two Q&A sessions which gave the audience the opportunity to pose Q&As to the MHRA panel. Delegates were invited to submit questions to the panel throughout the day using the MHRA Events App, and a wide range of questions were answered by the panel of Expert and Senior Inspectors. The Inspectorate commit to providing a written response to all questions submitted and the Q&As will be collated and made available to delegates in the New Year.

The event was drawn to a close by Richard Andrews who reminded delegates of the key themes of the day and take home messages which were:

  • Organisations need to maintain awareness of GMP requirements and ensure there are systems in place to identify new requirements and implement the required changes within the pharmaceutical quality system
  • Organisations need to consider the impact of company culture and management behaviour – the data integrity, IAG/CMT, deficiency data and investigation of anomalies presentations all identified company culture as being a key factor in improving GMP compliance
  • MHRA has, and plans to maintain a key role in EU and International initiatives

As with the use of new technologies this year, we are keen to continue evolving the format and content of the symposium to enhance stakeholder engagement. We are interested in receiving post evaluation feedback from delegates, and in response to this blog, to help us plan for next year’s event. 2016 was the third year we have held a four day joint GMP and GDP event, and we would be interested to hear your thoughts on how the joint back to back event format works for you.

HDA UK Media And Political Bulletin – 25 January 2017

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.

See the Infographic

Apply to become a Member

Membership of the HDA guarantees your organisation:

  • Access to leading policy and industry forums of debate and discussion
  • Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
  • Representation on HDA working parties, including the Members’ Liaison Group
  • A daily Political and Media Bulletin and HDA Newsletters
  • Access to HDA policy documents and all sections of the HDA website
  • Branding and marketing opportunities
Apply Now

Already a Member?