The abstracts of the 3A's Conference

The abstracts of the 3A's Conference
April 26, 2021

The 3 A's conference aims to give a new and renewed momentum to the discussion on how to address the longstanding topics that have been on the agenda of those with the highest responsibilities in the European pharmaceutical policy.

 

Abstracts of the presentations

 

DAY 1

KEYNOTE SESSION

Portuguese Presidency Priorities on Access to Medicines and Medical Devices

Speaker: Marta Temido, Portuguese Minister for Health

 

European Health Union and the Pharmaceutical Strategy for Europe

Speaker: Stella Kyriakides, European Commissioner for Health and Food Safety

 

European Parliament perspective on access to medicines and medical devices

Speaker: Dolors Montserrat, European Parliament, ENVI Committee

 

Introduction to Conference

Speaker: Rui Santos Ivo, President of Executive Board INFARMED, PT

 

PANEL I: AVAILABILITY OF MEDICINES AND MEDICAL DEVICES

Addressing shortages: preliminary results from the Commission study

Speaker: Andrzej Rys, European Commission 

 

Availability of Medicinal Products

Speaker: Nuno Simões, INFARMED

The causes of medicines shortages are multifactorial and the solutions require actions and solutions at different levels involving all stakeholders. Growing concerns at national level demand for greater coordination and sharing of information between Member States to avoid or mitigate the impact of shortages. Last year INFARMED has established a dedicated unit to manage availability issues and engage with stakeholders.

A common understanding for a list of critical medicines and medical devices

Speaker: Noël Wathion, EMA

Improving the availability of medicines authorised in the EU is a key priority for the European Medicines Regulatory Agencies. In the context of the COVID-19 pandemic, EMA was asked by the Member States (MSs) and the European Commission (EC) to take on the role of a central coordinator to actively support Member States’ COVID-19 shortage prevention and management actions, hence going beyond its current legal remit.  In this respect, EMA will explain its involvement in securing availability of medicines during the pandemic – in cooperation with the EC and the Member States – primarily by explaining the activities initiated by the EU Executive Steering Group (ESG) on shortages of medicines caused by major events, including the work of an Ad hoc Working Group (WG) on forecasting demand data tasked to establish a common framework for forecasting demand data in the EU/EEA. In addition, as a practical example, EMA will also elaborate on the methodology undertaken by the ESG to develop a “List of critical medicines for the treatment of COVID-19 patients” in April 2020 based on the input received from National Medicines Regulatory Authorities. EMA used this list of critical medicines to select a subset of high-impact COVID-19 medicines (31 active substances) monitored under the i-SPOC system, a fast-track shortage monitoring system to help prevent and mitigate supply issues in EU/EEA. The proposal for a reinforced EMA role – as part of the COVID-19 Health Response Package - includes a strengthening of the current role of EMA in shortages of medicines and crisis management and an entirely new role in the management of medical devices shortages. The new legislative proposal puts clear obligations to companies and MSs for reporting on shortages, supply capacity and demand data to the Agency, which will facilitate setting recommendations and coordination of measures to prevent or mitigate potential or actual shortages.

 

PARALLEL BREAKOUT SESSIONS

Session 1: National experience on shortage’s management

Rapporteur: Hugues Malonne, FAMHP

Session 2: Shortages management plans to avoid availability problems

Rapporteur: Josipa Cvek, HALMED

Session 3: Hospital Pharmacists solutions for availability problems

Rapporteur: Aida Batista, Vice-President EAHP

Session 4: Consumers and patients’ perspectives on medicines shortages, the case of small volumes and limited use medicines

Rapporteur: Monique Goyens, BEUC

 

PANEL II: ACCESSIBILITY AND INNOVATION OF MEDICINES AND MEDICAL DEVICES TO PATIENTS 

HMA-EMA joint strategy 2025

Speaker: Emer Cooke, EMA 

Medicines for Europe represents the European off-patent medicines (generic, biosimilar and value added medicines) industry, which provides close to 70% of all dispensed medicines in Europe and plays a crucial role in enabling equitable access to „standard of care“ therapies for patients while maintaining the health systems budgetary sustainability. Off-patent medicines demonstrated their pivotal role also during the current pandemic, between 70% and 90% of intensive care unit (ICU) medicines were off-patent medicines. To fully utilise the potential that the off-patent medicines provide there is a need to present an overarching and future-proof European legislative framework that will foster competition in the medicines market and enable timely uptake of generic and biosimilar medicines, at the expiry of intellectual property protection, for the benefit of all patients. What is the current state of play in the medicines market? What are some of the barriers preventing off-patent medicines from reaching the patients? And how the policymakers, the regulatory bodies and the industry can work together to deliver this change via thoughtful manufacturing, regulatory and pharmaceutical policies? The answers to these questions will be presented during this talk.

Speaker: Svens Henkuzens, ZVA

The presentation will illustrate the European Medicines Agencies Network Strategy 2025 and outline how this strategy aims at addressing challenges on availability of medicines and shortages. Hear on the creation, consultation and planned implementation of the European Medicines Agencies Network Strategy 2025.

 

PARALLEL BREAKOUT SESSIONS

Session 1: Access to medicines for special populations: Orphan and Paediatric Regulations & Revision of the system of incentives

Rapporteur: Helena Fonseca, PDCO and Violeta Stoyanova-Beninska, COMP

Session 2: Unmet medical needs: medicines and medical devices research in view of patients and health systems needs

Rapporteur: Marco Greco, EPF 

Session 3: How the repurposing of old medicines may add new value on patients’ access to new therapies

Rapporteur: Cesar Hernandez, AEMPS, ES 

Session 4: Generation of evidence for a better patient access & Health data space and big data: shared data for a better communication and coordination

Rapporteur: Xavier Kurz, EMA and Nikolai Brun, DKMA, DK 

 

PANEL II (cont): ACCESSIBILITY AND INNOVATION OF MEDICINES AND MEDICAL DEVICES TO PATIENTS

The new regulation of medical devices: State of play – Are we ready?

Speaker: Anna-Eva Ampelas, European Commission

Anna-Eva will provide a state of play of the implementation of the new Medical Device Regulation and refer to main achievements and challenges.

Will the new regulation promote accessibility of MD: Coordination, complexity and stringency vs. the need for regulatoryfexibility

Speaker: Thomas Wejs Møller, Chair CAMD

The main objective of the new Regulations (MDR and IVDR) is to enhance patient safety, but also to ensure continued market access for innovative health solutions. I will discuss to what extent the challenges in the current system will be addressed by the new regulation – and what do we still expect to battle with after the dates of application?

The technological, scientific and regulatory convergence between medicines and medical devices

Speaker: Niall MacAleenan, HPRA

 

DAY 2

 

PANEL III: AFFORDABILITY OF MEDICINES

Developing an “affordability” agenda under the pharmaceutical strategy for Europe to keep the sustainability of Health Systems

Speaker: Sylvain Giraud, EC

The presentation will highlight the “affordability” aspects of the Commission’s Pharmaceutical Strategy for Europe (Nov 2020) , the policy approach it promotes and the actions it proposes , thus developing an “affordability” agenda for cooperation between national authorities”

Effective ways of investing in health and patient access

Speaker: Pedro Pita Barros, Nova SBE 

Payment mechanisms of new products have, in the health care sector, to attain three objectives: (a) providing quick patient access; (b) providing the incentives for “innovation that matters”; and (c) being affordable to health care payers. There are inevitable trade-offs between those goals. Such trade-offs may be evaluated differently across time and across countries, leading to distinct choices by different countries, while innovation is global by its own nature. New payment models and (eventually) new institutional design of mechanisms rewarding innovation may provide a better, more effective way, of achieving the above-mentioned goals. These new models need to avoid some of the implicit incentives present in the current mechanisms.

Sustainability of healthcare systems: What costs? What value?

Speaker: Francisco Ramos, ENSP

 

ROUNDTABLE

The perspective of National Competent Authorities

Speaker: Momir Radulovic, JAZMP

The European Medicines Strategy recognises some long-lasting concerns of the accessibility and affordability of medicines. The future revision of regulatory procedures, incentives and obligations should address differences in access to medicines across the EU Member States, taking into account also the specificities of small markets. COVID-19 experience can be an inspiration for finding new approaches at EU level to ensure the accessibility of those medicinal products that suffer from lack of commercial interest. Different mechanisms, such as managed entry agreements or regional cooperation, are put in place to control the pharmaceutical spending and to preserve accessibility of medicines to patients. New technologies open new possibilities for patients, but innovation should remain affordable. The accessibility and affordability of medicines are intrinsically linked with the sustainability of health systems. The transparency in pricing, research and development of medicinal products would be the right step to long-term solutions.

 

The perspective of the Industry

Speaker: Nathalie Moll, EFPIA

A wave of new potentially curative treatments is being discovered and becoming available to patients and society, transforming healthcare – it should also cause us to transform the way we think, manage and resource healthcare. The recently released EFPIA Pipeline Review found that in 2020 alone, around 5,000 clinical trials were launched across disease areas for new treatments for unmet health needs. Despite the disruption caused by the COVID-19 pandemic, the volume of trials has increased over the past five years. However, this innovation only matters if it reaches patients in a timely manner. We need new shared solutions to make the most of this disruption and ensure the best possible health outcomes for patients and faster, sustainable and more equitable access to innovative medicines in Europe. For this reason, EFPIA strongly supports the call by the EU Health Coalition to the Portuguese Presidency for a European Forum for Better Access to Health Innovation to enable a shared understanding of the causes of access delays and the co-creation of shared solutions. Such an EU Forum bringing together Member States, EU policy makers and healthcare system actors would need to include a critical analysis of the reasons for delays and barriers to access followed by a shared commitment to find solutions, together. To contribute concretely to the analysis of the causes of delay, EFPIA publishes a yearly overview of the availability gap and access delays between different EU countries (WAIT indicator). The average delay between market authorisation of new medicines and patient access can vary by a factor greater than six across Europe. After investigating the root causes of unavailability and access delays, EFPIA identified 10 interrelated responsible factors. This analysis clearly concludes that only by working together is it possible to address the unavailability of medicines in Europe. To contribute proactively on the discussion around possible solutions, in 2020 EFPIA shared an overview of which New Pricing and Payment Methods are being used across Europe as opportunities to accelerate patient access, allowing payers to manage evidential uncertainty, spread the upfront cost and thus alleviate financial pressure on healthcare budgets, whilst providing sufficient incentives for innovation. Aiming at addressing concerns on the lack of transparency of these models, EFPIA has now identified six common principles that should govern the transparency of evidence from novel payment schemes, to ensure this data may improve the clinical practice, advance our knowledge and understanding of a particular disease or treatment, and ultimately bring greater benefit to patients, society and healthcare systems. The co-creation, adoption and transparency of novel pricing and payments models is just one part of EFPIA and its members’ wider pledge to help address delays and barriers to patients getting access to new treatments. By taking a more holistic and inclusive approach, agreeing on access barriers and co-creating new, flexible and collaborative solutions to ensure faster and more equitable access to medicines across Europe, together in an EU High Level Forum, we will transform the way we think, manage and resource healthcare to the benefit of patients.

Speaker: Christoph Stoller, MfE

Medicines for Europe represents the European off-patent medicines (generic, biosimilar and value added medicines) industry, which provides close to 70% of all dispensed medicines in Europe and plays a crucial role in enabling equitable access to „standard of care“ therapies for patients while maintaining the health systems budgetary sustainability. Off-patent medicines demonstrated their pivotal role also during the current pandemic, between 70% and 90% of intensive care unit (ICU) medicines were off-patent medicines. To fully utilise the potential that the off-patent medicines provide there is a need to present an overarching and future-proof European legislative framework that will foster competition in the medicines market and enable timely uptake of generic and biosimilar medicines, at the expiry of intellectual property protection, for the benefit of all patients. What is the current state of play in the medicines market? What are some of the barriers preventing off-patent medicines from reaching the patients? And how the policymakers, the regulatory bodies and the industry can work together to deliver this change via thoughtful manufacturing, regulatory and pharmaceutical policies? The answers to these questions will be presented during this talk.

Serge Bernasconi, Medtech Europe

 

Monika Derecque-Pois, GIRP

During her 15-minute intervention, Ms Derecque-Pois will outline the position of full-service healthcare distributors on the revolving themes of the conference: availability, accessibility and affordability. Ms Derecque-Pois will especially highlight the pivotal position of full-service health care distributors in ensuring availability of medicines and medical devices by bundling transactions, which in turn, allows for more efficient as well as more effective transactions from manufacturer to pharmacies and other healthcare professionals. She will then shift to an exploration of full-service healthcare distributors’ pertinent role in mitigating shortages, sharing sustainable solutions such as providing both expertise and infrastructure, advocating for full, fair and monitored implementation of existing regulations and calling to set in motion a European-wide strategy to mitigate the issues. With regards to accessibility, Ms Derecque-Pois will shed led light on the unique position of full-service healthcare distributors in ensuring continuous and timely access to the full range of medicines via the important role of buffer-stock and just-in-time delivery. Full-service healthcare distributors, through their stockkeeping and financing function, their extensive network of distribution centers and warehouses, as well as, through their logistic excellence are able to deliver any medicine in Europe within a very short time span to even the most remote location (average delivery time in Europe is 2.5h). She will conclude with final remarks on how full-service distributors are advocating for sustainable solutions which prioritise medicines availability, accessibility and affordability by outlining the core function of full-service healthcare distributors (also referred to as pharmaceutical full-line wholesalers), being the vital link for the fair, efficient, timely and safe distribution of all medicinal products, including medical devices and other medical supplies, to patients across Europe.

 

The perspective of patients & health professionals

Speaker: Yannis Natsis, EPHA 

 

Speaker: Annabel Seebohm, CPME

Close collaboration between Member States, public health authorities and stakeholders determines the possibility of timely access to safe, effective and affordable novel medicines. Member States should improve their cooperation at EU and regional level. For example, by working together and exchanging information on net unit prices, national pricing authorities can improve their negotiating position with pharmaceutical companies. Moreover, conclusions should be drawn from the experience gained during the COVID-19 pandemic on the added value of joint procurement and it should be discussed how to improve and expand joint negotiations, especially in health emergencies. Options for improving and expanding joint negotiations should be explored, especially during health emergencies. Similarly, HTA bodies can benefit from joint robust assessment of new medicines at EU level. Regulatory agencies, HTA bodies and payers working together and supported by patients, healthcare professionals and manufacturers can lead to meaningful comparative data on new products through, for example, the harmonisation of the designs and outcomes of clinical trials. Comparative data are critical for marketing authorisations, for assessing the potential benefits and harms of new medicines against existing ones, for making informed pricing and reimbursement decisions and, finally for allowing patients and doctors to choose the appropriate treatment. Accessibility and affordability of medicines is hindered by a lack of common understanding of key terms and concepts. The term “unmet medical need” should be defined to prioritise new technologies and prevent overuse of accelerated approval procedures. Also, the optimisation of the incentive system and the right functioning of the intellectual property rights framework require the agreement on what constitutes an “innovative medicine”. Lastly, cooperation of different health authorities across the EU should also lead to an overall increase of transparency. For example, HTA bodies and payers across Europe should routinely disclose information on the comparative benefits and harms of new and existing medicines.

Speaker: Ilaria Passarani PGEU 

At the heart of community pharmacists day-to-day mission lies their commitment to the safe, effective and rational use of medicines by patients, ensuring that the right patient receives the right medicine at the right time, along with the appropriate professional advice. Community pharmacists are sometimes faced with patients who are not able to pay for the medicine they need due to the high co-payment. Therefore, ensuring equitable and sustainable access to medicines for patients and health systems is an objective that PGEU shares with national governments and health systems, as well as with European and international institutions. The promotion of the rational and responsible use of medicines should be at the core of any policy aiming to enhance the affordability of medicines for health systems. This can be implemented by appropriately remunerating cost-effective healthcare services which show to improve therapy outcomes and adherence and minimise the risks related to using medicines. This includes an adequate, fair and sustainable remuneration of medicines dispensing and other services such as adherence-focused new medicines services , medicines use reviews  , implementation of validated clinical rules, common ailment, and chronic disease management,  services. Together with the promotion of the rational and responsible use of medicines, more investments in prevention and in strengthening primary care systems should be strongly encouraged. Moreover, generics uptake by community pharmacy should be incentivised to make medicines more affordable while rewarding community pharmacists for this important economically sustainable service. We also believe that strengthening EU cooperation on health technology assessment (HTA) by broadening regional initiatives such as Beneluxa or the Valletta Declaration Group should also be encouraged. Lastly, it is important to increase patients access to specialty medicines. In many countries innovative medicines and high price medicines are available only through hospitals which leads to inequalities in patients access. The dispensing of this medicines through community pharmacies increases equity of access, reduces costs to patients and can improve monitoring and adherence.

 

 

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