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 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.
The 1st Value Added Medicines conference organised by the Value Added Medicines Group, a sector group of Medicines for Europe, which took place today, 22nd November, gathered a wide range of experts in the healthcare community to raise awareness and foster debate on a common approach to present solutions for patient-centric innovation and better patient access to these medicines.
Health delivery models in Europe are being challenged by an ageing, rising patient population and current healthcare economic constraints, threatening the sustainability of Europe’s healthcare systems. There is a need for a new value proposition for patients, healthcare professionals and healthcare systems, especially to address clinical (adherence, quality of life) and economic inefficiencies. According to IQVIA, patient non-adherence is undoubtedly the biggest source of these, representing 57% of all inefficiency costs[1], and limiting the ability for patients to best manage their condition. Value added medicines can address these challenges by improving patient adherence and quality-of-life issues, while addressing medicine-related healthcare inefficiencies and improving healthcare provision and organisation thereby contributing to the sustainability of healthcare systems.
Marc-Alexander Mahl, Medicines for Europe President, highlighted that ‘We have a responsibility to look at European healthcare systems and see how we can contribute value to patients, healthcare professionals and society. Value added medicines deliver patient-centric gains. To continue the development of this sustainable innovation, there is a need for a favourable environment, where the development efforts can be reasonably recognised, and the access to value added medicines is well integrated in healthcare systems.’
Umberto Comberiati, Chair of the Value Added Medicines Group at Medicines for Europe, commented: “The wide range of stakeholders present at today’s conference has confirmed the wide interest surrounding value added medicines. We actively engage all the stakeholders from policymakers to patients, industry and payers to see how together we can address patients’ needs through the relevant outcomes that value added medicines can deliver. These benefits need to be more widely recognised and incentivised to promote the development of value added medicines in Europe. Pricing, HTA and market access pathways should be adapted to fully appreciate the benefits of this patient centric innovation”.
[1] IQVIA European Thought Leadership; IQVIA Institute 2012 “Responsible use of Medicine”
Medicines for Europe is very glad to see the Council of the European Union reach a decision today, to relocate the European Medicines Agency (EMA) to Amsterdam. This is an important milestone in the Brexit process, bringing us from a point of uncertainty to clarity concerning the future of the EMA and the important work it carries out for public health.
Of course, the real work starts now. Looking to the next steps in the process, we hope for a well elaborated relocation plan, which will provide certainty for both EMA staff and for the continuity of the work of the agency. In particular, we hope to see key EMA projects and coordination run smoothly, to avoid disruptions in pharmaceutical regulatory activities – ranging from the approval for marketing to the post-marketing surveillance of medicines. In this regard, we particularly look forward to the EMA continuing to implement important information technology projects like ISO-IDMP, and to lead the way on biosimilar medicines, both in the EU and globally. The pioneering work of the EMA on biosimilars in Europe has ensured that patient access to treatment has increased, and to let this, as well as other projects of the EMA, slip during relocation would have serious negative consequences.
Our primary concern is that now this decision has been taken, we as healthcare stakeholders now focus on continuing this work, which of course is paramount to ensuring supply and access to medicines for patients. We look forward to continuing this important work in Amsterdam, the new home of the EMA.
The newly elected President of Medicines for Europe – Marc-Alexander Mahl – launched the “Access to Medicines: Better Care for More Patients” campaign which calls on health ministers to fully embrace generic, biosimilar and value-added medicines to improve the sustainability of healthcare systems across Europe.
Dr. Mahl takes over the Presidency of Medicines for Europe for 2 years. As Executive Vice President Business Unit Generic Drugs at Fresenius Kabi, Marc-Alexander Mahl chaired the Hospital Sector at Medicines for Europe. A physician by training, he completed his specialization in transfusion medicine and blood banking in 2001, the year he also joined Fresenius Kabi. He also holds an Executive MBA from INSEAD.
Today, in Warsaw, Marc-Alexander Mahl explained: “European healthcare is under financial constraint with many patients struggling to get access to treatments. The increasing overall cost of healthcare will force policy-makers to make difficult and unpopular choices about how best to allocate resources. Yet there is a very simple and obvious way to ensure access while managing healthcare budgets: to promote generic, biosimilar and value added medicines use by patients, medical professionals and pharmacists.” The new campaign will provide compelling data and proposals to help policy-makers and stakeholders improve access to medicines. In particular, the campaign will help policy-makers encourage competition in complex, specialty medicine markets where there are tremendous opportunities to increase access, spend resources more efficiently and improve overall care for patients.
Value added medicines represent a major opportunity to improve patients’ quality of life, health outcomes or adherence, and to address a number of medicine-related healthcare inefficiencies, improving healthcare provision and organisation while contributing to the sustainability of healthcare systems.
To ensure access to value added medicines for patients, the Value Added Medicines Group, a sector group of Medicines for Europe, will participate in the ISPOR 20th Annual European Congress on an Issue Panel entitled “Value Added Medicines: Time To Adjust The Health Technology Assessment Decision Frameworks?”.
Moderated by Professor Michael Drummond (Professor of Health Economics at the Univerity of York), the panellists (Professor Mondher Toumi from the Public Health Department of Aix-Marseille University, Professor Ulf Persson from the Swedish Institute of Health Economics and Luigi Burgio – Head of Market Access Teva Italy and Chairman of the HTA Working Group at Medicines for Europe) will debate current challenges for capturing the benefits of value added medicines as well as key recommendations to integrate and recognise patient-centric innovation in HTA decision frameworks.
Umberto Comberiati, the Chairman of the Value Added Medicines Group,: “The time has come to explore new areas to deliver better health and access for patients, tapping into a sustainable source of patient-centric innovation. Value added medicines are an opportunity to deliver benefits to patients, payers and healthcare systems. However, there is a challenge to ensure that benefits can be appropriately assessed via HTA decision frameworks. The ISPOR Issue Panel will allow an informed debate among experts, industry and stakeholders.”
Medicines for Europe invites you to join the ISPOR European Congress in Glasgow and please follow us on Twitter and LinkedIn to know more about how European patients can better benefit from value added medicines. More information on the Issue Panel and the challenges and recommendations on adjusted HTA decision frameworks for value added medicines can be found here.