The joint 24th Medicines for Europe and 21st IGBA Annual Conference began today with key industry leaders coming together in Budapest, Hungary, to discuss the challenges and opportunities for the global generic, biosimilar and value added medicines industries.
Challenges related to industry sustainability were debated with key experts, who shared perspectives on topics such as medicines shortages, use of data, Brexit, international regulatory cooperation and the EU Falsified Medicines Directive (FMD). European industry leaders outlined the period of intense preparations to ensure compliance by the early 2019-milestones for FMD and Brexit.
The conference also underlined the exciting opportunities ahead for the industry. Having welcomed the European Commission legislative proposal for an EU SPC manufacturing waiver in May this year, Medicines for Europe is committed to supporting such industrial policy initiatives which can strengthen the European industrial base, increasing investments in R&D for biosimilar medicines, boosting EU competitiveness, and delivering faster access to medicines for patients.
Marc Alexander Mahl, President of Medicines for Europe, commented that “Medicines for Europe is committed to engaging with stakeholders and decision makers to improve patient access. In fact, to showcase our strong manufacturing footprint in Europe, Medicines for Europe has decided to launch an ‘Industry manufacturing week’, in which member companies will open production plants across Europe for stakeholders. We are leading suppliers of medicines for European patients and we want to engage with local communities to show that we are an integral part of the health ecosystem. “
David Gaugh, Chair of IGBA and Senior Vice President at the Association for Accessible Medicines, USA, commented that “the global perspective of the industry is crucial; key objectives such as international regulatory harmonisation and global collaboration to ensure the uptake of generic, biosimilar and value-added medicines can bring real benefits to patients – access and affordability are objectives we all share, right across the globe.”
Mr László György, State Secretary for Economic Strategy and Regulation, stated that “the primary goal of the newly established Ministry of Innovation and Technology is to maintain and improve decent living conditions and enhance the competitiveness of the pharmaceutical industry, which plays a decisive role in the Hungarian economy.”
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 International Generic and Biosimilar Medicines Association (IGBA) was founded as IGPA (International Generic Pharmaceutical Alliance) in March 1997 to strengthen cooperation between associations representing manufacturers of generic medicines from around the world. Its membership includes AAM (USA), CGPA (Canada), GBM – Southern Africa (South Africa), IPA (India), JAPM (Jordan), JGA (Japan), Medicines for Europe (Europe), and TGPA (Taiwan), while the associations from Australia (GBMA), Brazil (ProGenericos), Mexico (AMEGI), and Malaysia (MOPI) are Associate Members. The IGBA is at the forefront of preserving sustainable competition within our industry, by stimulating competitiveness and innovation in the pharmaceutical sector; thereby, ensuring millions of patients around the world have access to high quality, pro-competitive medicines. Through its constituent member associations, the IGBA maintains constant dialogue with government authorities around the world, as well as with international institutions such as WTO, WIPO and WHO. More information: www.igbamedicines.org
Key authorities, lawyers and industry leaders discussed today in London the key issues in the spotlight for the pharmaceutical industry legal framework: Brexit, the SPC regulation and changes in the EPO. The high level event assessed how various aspects of law affect access to generic, biosimilar and value added medicines in Europe.
The fast changing legal environment was assessed in areas such as the impact of Brexit on the industry, competition in pharmaceuticals including the European incentives review and biosimilar medicines litigation. Interactive expert roundtables covered highly technical topics including second medical use patents, paediatric extensions, statute of limitations in nullity actions, the falsified medicines directive, the role of competition policy to ensure free markets, the concept of plausibility, the practice of search and seizure, and disclosure and data protection and industry codes of conduct.
The anticipated Commission proposal for an SPC manufacturing waiver for pharmaceutical production and R&D in Europe and to foster high-skill job creation and economic growth was discussed in depth. According to a report published by the European Commission, the SPC manufacturing waiver would:
“Today’s conference reviewed pathways to encourage competition as well as innovation and growth in the pharmaceutical sector. Patients, governments and healthcare systems rely on a strong generic, biosimilar and value added medicines industry to increase access to medicines and to create jobs for Europe”, said Sergio Napolitano, Legal and External Affairs Director at Medicines for Europe, speaking ahead of the 14th Legal Affairs Conference, “an efficient, pro-competitive legal environment that includes the SPC manufacturing waiver will boost investments in our sector, facilitate faster access to medicines for patients, contribute to the sustainability of healthcare systems across Europe and we stand ready to support these positive measures”.
We, the signatories of this declaration, recognise and understand the concerns regarding the presence of pharmaceuticals in the environment.
We believe that these concerns can only be addressed through a dialogue with policy-makers, taking into account public health and environmental aspects, as well as their policy ramifications, and we pledge our commitment to remain open and constructive partners in this debate.
We look forward to the European Commission EU-wide strategy on pharmaceuticals in the environment. We call for a balanced approach that is mindful of the underlying essential role of medicines. We recognise that environmental protection contributes to safeguarding the health and safety of future generations; however, medicines also play a critical role in ensuring a high level of public health. As a matter of policy, we believe that any environmental-based measures should be clearly justified and guarantee patient access as well as access to the demonstrated benefits that medicines bring to public health.
We confirm our commitment to take actions in the areas where we can make a difference in order to reduce the presence of pharmaceuticals in the environment.
One such example of our commitment is the #medsdisposal campaign, a collaborative multi-stakeholder initiative aiming to raise public awareness about the correct disposal of unused and expired medicines. Around 8-10% of pharmaceutical substances in the environment originate from improperly disposed medicines – flushed down the toilet, poured into drains, or otherwise disposed inappropriately in household waste by patients or even by medical institutions [1],[2]. Educating citizens across the EU can therefore lead to a change in behaviour that can make a substantial difference.
While there is no evidence of harmful concentrations of active pharmaceutical ingredients in the European drinking water[3], we recognise that the possible impact of pharmaceuticals on the environment is generally unknown, and we support and encourage more research to identify and evaluate potential risks.
In addition, the representatives of the health sectors signing this declaration are taking additional actions in their own sectors to address the concerns around pharmaceuticals in the environment:
We would like to encourage more stakeholders to join and endorse the #medsdisposal campaign and pledge their commitment to address environmental concerns around pharmaceuticals. Should you be interested in doing so, do not hesitate to be in contact by email medsdisposal@gmail.com.
ABOUT US
#medsdisposal is a campaign to raise awareness on how to dispose of unused or expired medicines appropriately in Europe, bringing information on current disposal schemes in European countries to one place. It is a joint initiative between European healthcare, industry and student organisations including, among others:
AESGP
AESGP, the Association of the European Self-Medication Industry, is the representation of manufacturers of non-prescription medicines, food supplements and self-care medical devices in Europe. It is composed of national associations and the main multinational companies manufacturing self-care products. AESGP is the voice of more than 2000 companies operating in the consumer healthcare sector in Europe, affiliated with AESGP directly or indirectly through the national associations.
www.aesgp.eu
CED
The Council of European Dentists (CED) is a European not-for-profit association, which represents over 340,000 practising dentists through 32 national dental associations and chambers from 30 European countries. Its key objectives are to promote high standards of oral healthcare and effective patient-safety centred professional practice across Europe, including through regular contacts with other European organisations and EU institutions. The CED is registered in the Transparency Register with the ID number 4885579968-84.
EFPIA
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 40 leading pharmaceutical companies, 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.
www.efpia.eu
EPSA
The European Pharmaceutical Students’ Association (EPSA) represents more than 160,000 students and recent graduates from 37 European countries. The Association has a permanent office in Brussels and conducts its activities through regular congresses, advocacy activities, training events, publications, exchange programmes and virtual presence. The mission of the Association is to actively engage at student and professional level, bringing pharmacy, knowledge and students together while promoting personal development.
www.epsa-online.org
GIRP
GIRP is the umbrella organization of pharmaceutical full-line wholesalers in Europe. It represents the national associations of over 750 pharmaceutical full-line wholesalers serving 34 European countries, including major pan-European pharmaceutical full-line wholesaling companies
www.girp.eu
MEDICINES FOR EUROPE
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.
PGEU
The Pharmaceutical Group of the European Union (PGEU) is the association representing the 400.000 community pharmacists from 32 countries across Europe.
www.pgeu.eu
[1] Kümmerer, 2009: The presence of pharmaceuticals in the environment due to human use: present knowledge and
future challenges. J. Environ. Manage. , 8:2354–2358.
[2] European Environmental Agency, Pharmaceuticals in the environment, 2010:
http://www.eea.europa.eu/publications/pharmaceuticals-in-the-environment-result-of-an-eea-workshop/at_download/file
[3] WHO, Pharmaceuticals in Drinking-water, 2011:
http://www.who.int/water_sanitation_health/publications/2011/pharmaceuticals_20110601.pdf
Today’s agreement on a transition period is welcome news for Europe’s Life Sciences industry. While expecting a deal on the withdrawal agreement as soon as possible, this gives companies more certainty about the time they will have to prepare for the UK’s departure from the EU.
At the current status of negotiations, we continue to advise our members to prepare for every scenario and ensure that they have the right plans in place so that patients across Europe and in the UK continue to access the medicines they need.
However, as Article 50 negotiations progress to the next phase, clarity over the UK and Europe’s future relationship on the regulation, trade and supply of medicines needs to be provided as soon as possible. Alongside Europe’s patient groups and healthcare organisations, Europe’s Life Sciences industry will continue to advocate that the best outcome for patients is an agreement for the EU and the UK to continue to cooperate on medicines.
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.”
Photos:
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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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Kate O’Regan
Medicines for Europe
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Marie Petit
BEAM Alliance
marie.petit@beam-alliance.eu
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Daniel Seaton
Biotechnology Innovation Organization (BIO)
dseaton@bio.org
+1.202.470.5207
Danielle M. Blake
AdvaMed
dblake@advamed.org
+1-202-434-7233