The European Health Community has warned that time is running out to secure patients’ interests in Brexit negotiations. With Phase 2 of the negotiations looming, health groups across Europe have drawn up a list of crucial unanswered questions that must be answered by the EU and UK negotiators to ‘put patients first’ in the negotiations.
These questions were set out at a meeting of a Coalition of Brussels based health stakeholders on 21 February and have been released in advance of the European Council meeting on 22 March, where the guidelines for the negotiation of phase 2 will be agreed. These focus on how to prioritise patient safety and public health in the Article 50 negotiations on the future relationship between the UK and the EU. Each speaker posed three questions of importance which will need resolving for patients.
The Group has now published this document in light of the discussions by the EU27 on the draft guidelines for the future relationship between the UK and EU in the weeks to come. Some of the key questions the Coalition sets out are:
This follows on from the publication of a policy statement by the same group in December 2017[1]. The document outlined five priorities, which the group says will ‘determine the risk in Brexit’s impact on patients and public health across Europe’.
These priorities are:
Nicola Bedlington, General Secretary, European Patients Forum
“Brexit has great implications in various areas, public health, patient safety, access to medicine and medical devices, research and many others. This is so, not only for patients residing in the UK, but also in the rest of the EU(27). When it comes to those areas relevant to healthcare, patients’ interest should be shaping the agenda of both sides of the negotiating parties”
[1] http://www.eu-patient.eu/globalassets/library/publications/brexit–prioritising-patients—final.pdf
This week in London, Medicines for Europe gathers regulators and industry leaders to discuss future opportunities and challenges in the regulatory environment of the generic, biosimilar and value added medicines industry. Future changes in the regulatory landscape as a result of Brexit and the implementation of the Falsified Medicines Directive (FMD) will be discussed over the course of a two day conference in London. The opportunities for regulatory optimisation and international convergence will also be advanced as positive trends for the future.
The optimisation of regulatory operations, reflected in the HMA/EMA and CMDh 2020 workplans, are an important milestone for regulators and industry. In particular the ‘Regulatory Optimisation Group’ (ROG) offers a promising platform to find practical solutions for regulatory efficiency and operational excellence. Medicines for Europe will support this optimisation process for the benefit of patients and partners involved in or impacted by regulatory activities.
Marc-Alexander Mahl, Medicines for Europe President commented: “This conference provides an invaluable platform for stakeholders to adapt to the challenges posed by Brexit and FMD implementation while seizing opportunities to progress on regulatory optimisation and convergence for a more efficient system. Efficient regulatory systems will play a key role for patient access to medicines across Europe.”
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National authorities, regulators, industry leaders and key stakeholders gathered in London this week to discuss how to improve patient access to safe medicines with an effective pharmacovigilance framework. This 11th edition of the Medicines for Europe pharmacovigilance conference highlighted the need to engage effectively with patients and making sure the information is communicated in a clear and real-time matter. As modern technology advances, industry and regulators have an unprecedented opportunity to include patients in pharmacovigilance activities, a key element of patient involvement.
When ensuring pharmacovigilance systems remain effective, it is crucial to think not only of the operational aspects but also that every effort should be made to ensure that systems are sustainable. The 11th Pharmacovigilance conference dedicated sessions to the future of our current systems, in addressing issues such as enhancement of the Eudravigilance database, audits and inspection practices that need rethinking and how to maximise the use of electronic reporting, and minimise waste and overlap in the system.
Adrian van den Hoven, Medicines for Europe Director General commented: “Efficient pharmacovigilance is paramount to ensuring the safe use of medicines. Industry and regulators have a shared responsibility to ensure that this system remains effective and efficient. Together, we can reduce waste in the system, improve operational efficiency, prioritise and focus on processes which bring the highest benefits to patients. We commend the regulatory community on the close cooperation in the implementation the enhanced Eudravigilance and look forward to developing a clear roadmap to focus on the highest risks for patients while reducing the overload of non-essential data that the system currently generates.”
Geneva, 18 January 2018 – Today, the AMR Industry Alliance launches its first report that shows the commitment of the life sciences industry to tackle the public health threat of antimicrobial resistance (AMR). The Alliance brings together over 100 biotech, diagnostics, generics and research-based biopharmaceutical companies and trade associations from 20 countries. The report was compiled by the consultancy SustainAbility. The data and case studies collected in the Alliance report provide unique insights into the practical steps members are taking to respond to AMR in the areas of research and science, access, appropriate use, and the environment. The report presents data on AMR-relevant products, including therapeutic agents or technologies that have the potential to treat or prevent infectious diseases and/or combat resistance, including but not limited to antibiotics, vaccines, diagnostics, and novel approaches to address AMR. The Alliance showcases industry’s efforts and commitment to fulfil its role as a necessary and constructive partner in finding sustainable solutions to tackle AMR.
Today, an estimated 700,000 people die each year because of the growing number of potentially deadly infectious pathogens. These include pathogens that cause tuberculosis, HIV, malaria, and staph infections, which have developed resistance to treatment regimens. AMR has the potential to turn back the clock on modern medicine. In response to this public health threat and its social and economic consequences, the United Nations in 2016 called for concerted action from governments and various sectors to address the implications of AMR. The AMR Industry Alliance is the life sciences industry’s response to this call for action.
“This first report is ground-breaking for several reasons,” explains Thomas Cueni, chair of the Alliance. “It is unique in that the companies have committed to walk the talk together and report on their progress. It is the first industry-wide grouping of this scale that has been set up to respond to the AMR emergency.”
Adrian van den Hoven, Director General, Medicines for Europe commented “The AMR Industry Alliance report is a key milestone in cementing industry commitment to tackling this global challenge in a collaborative manner. In fighting AMR, the right balance should be found between facilitating access while ensuring appropriate use. This can only be achieved by multiple stakeholders working together to define the principles of appropriate use, which ensures that public health remains safe-guarded. Patients who need antibiotic medicines should be able to have access to the appropriate treatment they need to get better. Equally, medical professionals need to be able to choose from a wide range of antibiotics to provide optimal treatment for their patients. The AMR Industry Alliance, and Medicines for Europe as member, is committed to being part of this dialogue, and taking action which we hope will change the tide on AMR.”
This first progress report has aggregated data from 36 companies from all four categories represented in the Alliance: all research-based biopharmaceutical companies (11 out of 11), half of the generics (3 out of 6), one third of diagnostics members (5 out of 15), and one quarter (17 out of 68) of SMEs provided input. The Alliance is committed to reporting progress every two years. It is also dedicated to refining its approach to better address the challenges for its members in responding, so that it can achieve greater participation than seen in this first report.
The submitted data provides considerable insight into private sector efforts to curb AMR and shows that “broadly the Alliance membership is already active and making positive contributions to the challenge of AMR, even though there is a long way to go – on full Alliance participation and greater gains against AMR,” said Denise Delaney, Director at SustainAbility.
Research and science: The report confirms a broad commitment to research by companies in 2016. At least USD 2 billion in R&D was dedicated to AMR-related products in 2016. This is a conservative number as it corresponds to the data provided by only 22 companies. These investments cover R&D-related costs for early-stage R&D exploring new product classes, ten antibiotics in late-stage clinical development, 13 clinical bacterial vaccine candidates, and 18 AMR-relevant diagnostic products, as well as other preventive therapies. A majority of Alliance companies viewed R&D incentives as either “promising but with far to go” or “insufficient relative to the challenge.”
Access: While vast amounts of antimicrobials, especially antibiotics, go to waste on patients and animals who do not need them, almost six million people die each year from infections, because they lack access to these medicines. The Alliance supports protecting the efficacy of antibiotics and making them available, where necessary, to every human being. More than two out of three Alliance companies surveyed with marketed AMR products have strategies, policies or plans in place, which include principles or efforts to improve access to their AMR-relevant products. A similar number of companies are engaged in dialogue with external stakeholders on improving access to their AMR relevant products. Many of the Alliance generics and R&D-based biopharmaceutical companies with AMR-relevant products believe more work is needed to determine how to balance expanding access with appropriate use, reduce falsified products, and work with other stakeholders to address access issues in low and middle income countries.
Appropriate use: Over 80% of all responding companies are engaged in activities to support appropriate use, while nearly half of the responding companies have a formal appropriate use strategy in place. Nearly 90% of responding companies – and 70% of those with AMR-relevant marketed products – are planning to, currently collecting or support the collection of surveillance data. More than half of the responding companies are planning to, or are currently engaged in, stewardship education activities, directly or collaboratively. This number increases to 70% for those companies with a marketed AMR-relevant product. However, it is broadly acknowledged that there is a considerable way to go, and the potential of vaccines and diagnostics is not yet fully explored.
Manufacturing and the environment: Alliance companies, particularly those that made bold commitments in the Roadmap, are taking action to reduce the potential impacts of antibiotics manufacturing on AMR. One third of the Alliance companies that produce antibiotics currently have a strategy, policy or plan in place to address the issue of the release of antibiotics in their own manufacturing effluent that may contribute to AMR. Three quarters of them anticipate the implementation of good practice methods to reduce environmental impact of manufacturing discharge by 2018, well ahead of the 2020 target. The report also features a newly drafted common framework for managing antibiotic discharge across company supply chains.
Progress report: https://www.amrindustryalliance.org/progress-report/
About the AMR Industry Alliance
The AMR Industry Alliance is a coalition of over 100 biotechnology, diagnostic, generics and research-based biopharmaceutical companies and trade associations that was formed to drive and measure industry progress to curb antimicrobial resistance. The AMR Industry Alliance ensures that signatories collectively deliver on the specific commitments made in the Industry Declaration on AMR and the Roadmap and measures progress made in the fight against antimicrobial resistance.
About SustainAbility
SustainAbility is a consultancy and think tank enabling business to lead on the sustainability agenda.
Press contacts:
Morgane De Pol
IFPMA
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+41 22 338 32 20
Kate O’Regan
Medicines for Europe
koregan@medicinesforeurope.com
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Marie Petit
BEAM Alliance
marie.petit@beam-alliance.eu
+33 6 50 01 15 33
Daniel Seaton
Biotechnology Innovation Organization (BIO)
dseaton@bio.org
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Danielle M. Blake
AdvaMed
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Today, organisations representing the life science industry in the EU and the UK have called for medicines to be a priority in phase 2 of the Article 50 negotiations.
Setting out their priorities in advance of the European Council taking place on 14-15th December in Brussels, the sector has sent a clear message that the regulation, trade and supply of medicines must be a priority for the second phase of negotiations.
Whilst being encouraged by the breakthrough in phase 1 of the negotiations so that the second phase can now begin, the sector states that focusing on the framework for transitional arrangements and future relations with the UK must be a priority for negotiators.
The organisations are of the opinion that the agreement of transitional arrangements after March 2019 will be critical in ensuring there is minimal disruption to patients receiving medicines after the UK leaves the EU. Such a period will be essential in allowing companies to make the necessary changes to marketing authorisations and to their supply chains and ensure patients experience no disruption to their access to medicines. As such, negotiators should include access to medicines and the implications of Brexit for patients across the EU in the second phase of negotiations and be agreed in both the future agreement and in transitional arrangements.
The publication of this joint policy paper shows that the integrated nature of the supply chains for medicines across Europe, alongside a shared regulatory framework, means that patients in both the UK and EU need an early agreement on the future of medicines in phase 2 of the negotiations.
Among several key priorities, the joint paper sets out the following:
Hubertus Cranz, Director General, Association of the European Self-Medication Industry (AESGP), stated:
“Self-care products are often the first choice when European citizens face a health issue. Phase two of the Brexit negotiations should make sure that the availability of non-prescription medicines and self-care medical devices is not put in danger. This requires an open minded, pragmatic approach concerning the transitional arrangements, but also for the long-term relationship between the UK and the future EU27. Concrete proposals have now been put on the table and we are confident that they will make a constructive contribution to the further negotiation process. The current EU regulatory network should be kept intact as much and as long as possible to avoid disruption to the supply of all kind of self-care products.”
Mike Thompson, CEO, Association of the British Pharmaceutical Industry (ABPI) said:
“As we look forward to confirmation of sufficient progress between the UK and the EU in Brexit talks, securing the best possible deal in phase two of the negotiations is now our focus.
“In phase two it is crucial that the regulation and supply of medicines for UK and EU patients is prioritised. A cooperation agreement between the UK and the EU on medicines is the best way to ensure that there is no disruption to 500 million patients receiving the medicines that they need.
“This agreement, alongside a single-step fixed-term transition period that allows companies to make any necessary changes to the supply chain, will be critical. Protecting public health in the UK and Europe must be a priority.”
Warwick Smith, Director General of the British Generic Manufacturers Association (BGMA) and the British Biosimilars Association (BBA), said:
“We welcome the progress in Brexit talks but urge that in the second stage clarity is prioritised for the pharmaceutical sector. We have consistently stated that the existence of a single European regulatory system for medicines has generated considerable benefits for patients, the NHS and the industry. Both sides in the Brexit negotiations must find a way of maintaining these benefits in the interests of their citizens.”
Steve Bates, CEO, UK BioIndustry Association (BIA), said:
“The complex issues surrounding medicines regulation and supply chain need to be front and centre in the second phase of talks and industry needs a realistic transition period to ensure that the supply of lifesaving and life extending medicines to patients in the UK and across Europe is not affected. The life sciences industry stands ready to lend its expertise to the negotiating teams to ensure that there is no negative impact on public health and health security due to Brexit.”
Nathalie Moll, Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA) said:
“The joint agreement announced last week between President Juncker and Prime Minister Theresa May provided a welcome breakthrough towards phase 2 of the negotiations. It is critical that this is confirmed by the European Council, and discussions move on as soon as possible to agreeing cooperation between the UK and the EU on the regulation, trade and supply of medicines. Health security must be a priority in this next stage of negotiations, alongside securing a transition period beyond March 2019. This is critical for patients in the UK and Europe.”
Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
“Small and mid-sized companies are an indispensable factor for innovation in the healthcare and life sciences sector, and are catalysts of growth and competitiveness in Europe. To ensure that Europe and its patients continue to benefit from this, it is imperative that their capacity to operate is protected through the Brexit negotiations by minimising uncertainty and ensuring as much continuity as possible in the regulatory process between EU-27 and the UK.”
John Brennan, Secretary General, European Association for Bioindustries (EuropaBio), said:
“The simple facts are these: Many, many, European medicine approvals and European medicinal supply lines run through London and the UK. No matter how fast the Biotech industry and European drug approval authorities work together, we cannot succeed in adapting all drug approvals and all drug supply lines in time and by the 29th March. So the question to the negotiators is this: Do you want to prioritise medicines and allow an adequate transition, or do you want to risk interruption in the supply of life saving medicines to EU and UK patients?”
Adrian van den Hoven, Director General, Medicines for Europe said:
“We warmly welcome the important developments being achieved in the Brexit negotiating process. The recent compromise on the three key issues of phase one of the talks paves the way for discussions on the technical aspects of the future agreement, including public health.
In this regard, patient access to medicines should be of primary concern for negotiators as phase two of the talks begins. This encompasses a wide range of activities, including facilitating workable trade and customs mechanisms to ensure continued circulation of medicines between the UK and future EU27, as well as legal and regulatory provisions which enable companies to continue to supply European and British patients. This is particularly pertinent for the generic, biosimilar and value added medicines industry, which currently supplies the majority of medicines to patients in the European region.”
John Smith, Chief Executive, Proprietary Association of Great Britain (PAGB), comments:
“PAGB also welcomes that both parties have agreed the principles that goods on the market before withdrawal can continue to freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling. Thereafter, PAGB believes it is vital that appropriate mutual recognition agreements are put in place to allow over-the-counter and self-care products manufactured in the UK to continue to be exported to the EU and vice versa.”
The European Commission launched today additional translations of the Q&A paper “What I Need to Know about Biosimilar Medicines – Information for patients’’ making it available now in 23 official European languages, in order to provide patients with easy-to-understand information about biosimilar medicines. The Q&A was written to empower patients by providing answers to the most-frequently-asked questions on biosimilar medicines.
What are biosimilar medicines? How are they produced? How are they approved? Are they safe? – These questions and many more are addressed in this paper. Empowering patients to engage, discuss and participate in decisions on their treatment options is key to improving patient outcomes and contributing to the effective treatment of their individual condition(s).
In Europe, the introduction of biosimilar medicines brings competition, with the potential to improve patient access to biological medicines and contribute to healthcare system sustainability. Biosimilar medicines help treat many complex diseases, including cancer, diabetes, and autoimmune diseases (such as rheumatoid arthritis and inflammatory bowel disease). Biosimilar medicines have been used safely in the EU since 2006 as an alternative to reference medicines.
This Q&A is an initiative by the European Commission Directorate General for the Internal Market, Industry, Entrepreneurship and SMEs (DG Grow) on access to biosimilar medicines in Europe, in relation to the Corporate Responsibility Programme. This consensus information on biosimilar medicinal products was drafted by and for patients together with representatives of the European Medicines Agency, the European Commission and concerned stakeholders [the European Patients Forum (EPF), the European Federation of Crohn’s & Ulcerative Colitis Associations (EFCCA), the Standing Committee of European Doctors, European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for BioIndustries (EuropaBio) and Medicines for Europe]. The Q&A was first launched in English in January 2017.
The above stakeholders would like to congratulate the European Commissions’ DG GROW and the European Medicines Agency on the developments during this programme. The Patient Q&A amongst other documents, such as “Biosimilars in the EU – Information guide for healthcare professionals” and “What you Need to Know about Biosimilar Medicinal Products – A Consensus Information Document”, have contributed significantly to the increased understanding and acceptance of biosimilar medicines.
The Standing Committee of European Doctors (CPME) represents national medical associations across Europe. We are committed to contributing the medical profession’s point of view to EU institutions and European policy-making through pro-active cooperation on a wide range of health and healthcare related issues.
For more information please contact:
Miriam Beatrice Vita D’Ambrosio, Communication and Project Officer
Email: miriam.dambrosio@cpme.eu / Telephone: +32 2 738 03 12
EPF currently represents 74 members, which are national coalitions of patient’ organisations and disease-specific patient organisations working at European level. EPF reflects the voice of an estimated 150 million patients affected by various chronic diseases throughout Europe.
EPF’s vision is that all patients with chronic and/or lifelong conditions in the EU have access to high quality, patient-centred equitable health and social care.
The EPF strategic goals focus on areas such as health literacy, healthcare design and delivery, patient involvement, patient empowerment, sustainable patients’ organisations and non-discrimination.
For more information please contact:
Sara Gayarre, Communications Assistant
Email: sara.gayarre@eu-patient.eu / Telephone: +32 2 274 08 64
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world. To learn more about EFPIA, visit: www.efpia.eu
For more information please contact:
Faraz Kermani, Communications Manager – External Affairs
Email: communications@efpia.eu / Telephone: +32 2 626 25 55
EuropaBio, the European Association for Bioindustries, promotes an innovative and dynamic European biotechnology industry. EuropaBio and its members are committed to the socially responsible use of biotechnology to improve quality of life, to prevent, diagnose, treat and cure diseases, to improve the quality and quantity of food and feedstuffs and to move towards a biobased and zero-waste economy. EuropaBio represents 79 corporate and associate members and bio-regions, and 17 national biotechnology associations in turn representing over 1800 biotech SMEs. Read more about our work at www.europabio.org.
For more information please contact:
Cosmin Popa, Communications and National Associations Manager
Email: c.popa@europabio.org / Telephone: +32 2 739 11 73
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
The Biosimilar Medicines Group is a sector group of Medicines for Europe and represents the leading companies developing, manufacturing and marketing biosimilar medicines across Europe. Our members bring competition to the biologic medicines market, thereby increasing access to highly innovative medical treatments for patients in Europe and around the world, and supporting the sustainability of the European healthcare systems.
For more information please contact:
Andrea Bedorin, Communications Manager
Email: abedorin@medicinesforeurope.com / Telephone: +32 2 239 20 14
The associations representing the European and British life science industry (AESGP, EFPIA, EuropaBio, EUCOPE, Medicines for Europe, ABPI, BGMA, BIA, PAGB) have today underlined the importance of securing cooperation between the UK and EU on medicines regulation.
Whilst we respect the phased approach of negotiations, we urge progress to be made in the negotiations as soon as possible.
We urge Brexit negotiators on both sides to agree on a transition period that adequately reflects the time needed by companies, as well as all relevant authorities at EU and national level to adapt to changes in view of the UK exiting the EU. The transition period should provide for continued EU-UK partnership on the regulation and supply of medicines, to avoid supply disruption while moving forward towards a future cooperation agreement between the EU and the UK.
Our industry is highly integrated across Europe, and regulated under EU law through a sophisticated system of legal and regulatory arrangements involving EU Institutions, Member States and national competent authorities.
For our sector Brexit represents a challenge in several areas, notably regulatory procedures, quality testing of medicines, supply chain, trade, and intellectual property. For example, medicines companies may need to submit applications for the transfer of marketing authorisation for many products, move batch release sites and duplicate quality testing for products or move personnel into either jurisdiction. This will take a significant amount of time and will result in capacity issues which cannot be resolved before March 2019.
Clarity and certainty are needed as early as possible to enable our industry to make the necessary changes and to transition smoothly into the new framework. This is key to ensure that there is no disruption in the supply of medicines tor patients after March 20191.
Even in the context of the Brexit negotiations where all sectors are looking for clarity on the future, it’s important to recognise that medicines are different. Our goal is ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines through Brexit and beyond, and to ensure that there is no adverse impact on public health. This goal should be front of mind for both the EU and UK negotiating teams.