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Better Access, Better Outcomes -Shared Vision, Shared Responsibility

29 June, European Parliament

Meeting Report

Interest Group co-chair Karin Kadenbach MEP opened the meeting, expressing her sympathy with the victims of the Istanbul attack. She went on to welcome the numerous participants representing the variety of stakeholders in the health and pharmaceutical area and underlined the timeliness and relevance of today’s discussion.

Ms. Kadenbach then gave the floor to co-chair Andrey Kovatchev MEP who re-iterated the aim of the Interest Group to provide a platform to stakeholders to discuss all topics related to access to health care. The Group provides the opportunity for MEPs to listen to stakeholders’ views, which can then be transmitted to the European Parliament Committee on Environment, Public Health and Food Safety (ENVI Committee) and plenary sessions. He also referred to the current turbulence in Europe, as a consequence of the Brexit.

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Co-Chair Katerina Konecna MEP then spoke about her views on the need to improve access to medicines, stating that the protection of public health is one of the important tasks of the ENVI Committee. However, the current remit of this Committee is too broad and issues relating to medicines are not often recognised as a primary topic. Therefore, there should be a separate and dedicated health committee to do justice to the importance of health – for people as well as the economy - at EU level.

Issues relating to health policy are mostly a national competence, with Member States aiming to keep their health systems sustainable. Cultures are different and health systems vary. The level of access to health care also varies. However, this does not mean that there cannot be cooperation and communication between the Member States; national policies should be con-sistent with European recommendations.

In relation to the topic, i.e. access to medicines, she referred to the Parliament’s upcoming Own Initiative (INI) report and suggested for this to take account of the following issues:

There is a need for connections between the various existing health care systems as well as between healthcare and welfare systems as not having access to treatment can lead to persons having to rely on welfare systems. If this happens, not only will costs be higher, here will be a waste of human resources as well.

It is important to look at medicines from a market perspective. In some countries short-ages of medicines exist and in some cases this is due to parallel trade. This needs to be avoided and the possibilities of better regulation in this area should be explored.

Karin Kadenbach MEP then gave the floor to Andrzej Rys (European Com-mission, DG Sante) who provided an overview of the activities of the Commission in the field of access to medicines.

Mr. Rys started by listing the common challenges in this area, such as the high percentage of pharmaceutical spending (15% of health expenditure), the increasing consumption of medi-cines (due to ageing and new technologies), the proliferation of high costs medicines (ques-tioning current pricing models) and the financial sustainability of health systems which are under pressure.

Debate on access to medicines is taking place at national, EU and international level, address-ing the proportionality of prices with health benefits, the affordability and access to effective treatment and the efficiency of pharmaceutical spending. In terms of solutions, issues related to balancing value and sustainability, access to effective and affordable medicines for pa-tients, value for money for patients and payers and sustainability of health systems come into play. Various policies are implemented options can be explored to address the challenges such as increasing the opportunities for generics, changing behaviours for cost effective pre-scription/use of medicines and encouraging the development of new products that address unmet needs. Equitable access to these products needs to be ensured while guaranteeing the sustainability of health systems. HTA should be developed as a key tool to inform on coverage and funding decisions.

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Mr. Rys listed the various actions that the Commission has already undertaken such as facili-tating the development and authorisation of innovative medicines for unmet medical needs (by means of IMI), identifying ways to optimise the use of existing regulatory tools (EMA is currently conducting projects on adaptive pathways, and PRIME and the MSs are discussing and reviewing options in a special working group called by means of STAMP), encouraging coordination between innovators, HTA and regulators (through cooperation between EMA and national agencies/EUnetHTA/HTA Networkbodies/payers) and strengthening cooperation on HTA (EUnetHTA).

The Commission now will respond to the call in the June 2016 Council conclusions, which call on the Commission to carry out an evidence-based analysis of the impact of the industry in-centives in the current EU legislative instrument on innovation as well as on availability. There is also a commitment to respond to the invitation from the Member States to assess the impact of SPC, data protection and market exclusivity incentives from the health perspective, with a particular focus on innovation, availability and accessibility.

The Commission has also taken initiatives on orphan medicinal products and pediatric medi-cines; and encourages the voluntary cooperation of Member States on pricing and cost con-tainment is encouraged and supported. In this respect, Mr. Rys underlined the cost effective use of medicines as part of the EU Agenda for effective, accessible and resilient health sys-tems; encouragement to rationalise pharmaceutical spending is part of the European Semester process analysis as reflected in several country reports and country specific recommendations of the European Semester process. The Commission is has also issued in 2016 carrying out a study on pricing mechanisms and has continued to support , providing a tool for the exchange of transparent information on prices (EURIPID).

Lastly, Mr. Rys focused on HTA as a tool to assess the added value (relative effectiveness) of a given health technology over and above existing ones. HTA has the potential to improve patients’ access to technologies with added value and allows Member States to take rational decisions on how to best use health care budgets. It can also provide a stimulus/incentive for the industry to innovate. The Commission is planning to publish a HTA Network Reflection paper on synergy between regulatory and HTA issues by the end of the year. The EUnetHTA Joint Action will end in 2020; a reflection process has been started to ensure a strengthened EU cooperation on HTA after 2020.

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The next speaker, Christian Siebert (European Commission, DG GROW) also underlined the Commission’s interest in access to medicines. He emphasized the complexity of the issue by introducing two ‘fundamentals’: the first relates to a triangle of interrelated concepts, i.e. sustainability, innovation and access. These three concepts have a mutual im-pact and influence. Each of these has its own value and it is not easy to determine the precise impact of specific actions and incentives on the individual elements - as well as on their inter-relation.

The second ‘fundamental’ relates to the three stages of access of medicines: market authoriza-tion (where the Commission has a major role in relation to the approval, based on a determina-tion of the drugs’ efficacy, quality and safety), assessment of the benefit of a medicine (Health Technology Assessment) and decisions on pricing and reimbursement – which is the exclusive competence of the Member States.

A multi-stakeholder approach is crucial if progress is to be achieved, involving the Member States, patients, industry, healthcare personnel, and others. Exchanging information and ex-perience with regards to effect of actions in this field will need to be part of the discussion. Involving all stakeholders in assessing certain models or actions can lead to a useful frame-work to see what the specific effect of models and tools can be, such as in the area of pricing/reimbursement.

Christian Siebert expressed his appreciation for the efforts of the Dutch EU Presidency which has led to the adoption of a set of relevant Council Conclusions. These address the various current incentives for the industry and call on the Member States and the Commission to have a closer look at the impact of different measures.

This complex issue has been on the agenda for a long time. A longer term and strategic view is now required to follow certain questions over a longer period and to get experience in this complicated area.

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The next speaker, Dr. Marcel van Raaij (Ministry of Public Health, Welfare and Sports, NL) provided information on the activities of the Dutch presidency in relation to pharmaceuticals. The Dutch EU Presidency had ‘Strengthening checks-and-balances in the pharmaceutical system’ as a core theme. As ‘leitmotiv’ the presidency used “Timely access to innovative products but with affordable prices”. The presidency had the aim to improve voluntary cooperation and exchange of information on pricing and reimbursement between Member States, to start an analysis of (un)desired effects of the incentives in the EU pharma legislation and their impact on innovation and costs, and to trigger a broad debate about the future challenges in the pharmaceutical system.

This was a priority topic in view of the increasing mismatch between marketing authorisation and access to the final products. Although various products are coming to the market with good prospection for patients, the continuing increase of the high prices of these products form a threat to the sustainability of European Health Care systems, which hinder patient access. A number of meetings addressing these themes took place over the past six months. One of the main outcomes was the agreement of several Member States with the notion that there are imbalances in the pharmaceutical system and that action is needed. While there is a concern about sustainability of health care systems, there is also support for voluntary coop-eration on pricing and reimbursement, e.g. between economically similar countries.

However, it was found that voluntary cooperation should have clear added value; decisions on pricing and reimbursement should remain the prerogative of the member state. Moreover, addressing the unintended effects incentives should not discourage innovation.

The main outcome of the Dutch Presidency is a set of Council Conclusions entitled ‘Strength-ening the balance in the pharmaceutical systems in the EU and its Member States. This is a po-litical statement which serves as a recognition of the imbalances in pharmaceutical systems. Concern about sustainability is also expressed.

The Conclusions include specific actions for Member States, such as for them to invest in voluntary and Member State driven cooperation on pricing and reimbursement (information sharing, negotiations with selected countries and cooperation on HTA), set up strategic policy reflection and exchange between Member States and develop a list of shared challenges and actions for 2017-2020 and collaboration across the system to ensure follow up actions.

Specific actions for the Member States and the Commission include instigating cooperation and setting clear and enforceable (pre-) conditions regarding the use of early access tools, further develop cooperation on HTA, strengthen dialogue and cooperation in existing phar-maceutical fora, investing in essential R&D to address unmet medical needs and registries and promote open access to data and ensure fair return on investment of successful publicly funded research.

Lastly, specific actions for the Commission include streamlining implementation orphan regu-lation, ascertain proper application rules, incentives and rewards and revise these if neces-sary, create an overview of EU pharma legislation in relation to IP related incentives and their intended purpose and analyse the (un)desired effects of these incentives on innovation, acces-sibility, availability and affordability of medicines, as well as the industry’s pricing strategies.

The functioning of the EU pharma market in terms of transparency, market behaviour and competition and strengthen market oversight also needs to be addressed; if possible, rec-ommendations for possible solutions remedies should be put forward in the context of the agenda for 2017-2020.

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The next speaker, Soledad Cabezon Ruiz MEP, in her role as Rapporteur, introduced the upcoming INI report on access to medicines and underlined the importance of clarifying what is understood by the ‘pharmaceutical products market’. We need to find measures to make medicines accessible – but in order to do so we need to know the market. Systems can be changed; the present system was put in place in the 70ties and was based on Intellectual Property rights (IP) in order to guarantee Return on Investment (ROI). But it is fair to say that the costs involved with researching and producing medicines are to some extent public costs as well – the costs are not only borne by the pharma industry. More transparency is required in this respect.

This market is different from others as one of its essential characteristics is related to the right of citizens to have access to health. There is a balance to be struck in this respect as Member States have to guarantee that right while balancing costs and budgets.

However, the demand is currently industry-driven. The market is fragmented and non-elastic, with huge price differences across the board. Those with low incomes suffer most in trying to get access to innovative medicines. Moreover, industry decides in which areas research will be carried out – and these priority decisions are largely based on potential profit.

There is a scarcity of medicines in certain countries, which is mentioned in the Council Con-clusions; o better regulate and control this market. The pharma industry is of course hugely important to the EU: it represents 200 billion euros as well as 800.000 employees. It is neces-sary to gain an understanding with the industry, which is highly competitive. The current ROI is 20 percent – a balance therefore needs to be found.

This area is viewed as part of the sole competence of the Member States as it is linked to health. However, the Treaty does provide a legal base for EU level action, for instance by ad-dressing monopoly and dominant position of industry (e.g. Articles 81, 82, 101, and 102).

Soledad Cabezon Ruiz informed the audience that her report is currently being drafted and will address issues related to quality, safety and innovation, as well as therapeutic value; new medicines should be superior to existing ones. The quality of innovation should also be dem-onstrated. Moreover, it will also look at how industry sets product prices, taking their value into account.

The report will be discussed in the ENVI Committee in October and probably be discussed in plenary in January.

Karin Kadenbach MEP then handed over to Nicola Bedlington (European Patients’ Forum) and Stanimir Hasardzhiev (Patient Access Partnership) to chair the second part of the meeting.

Stanimir Hasardzhiev briefly introduced PACT and its objectives, stating that PACT is com-mitted to promoting equal access to healthcare. He underlined that medicines are a product like no other as patients ‘lives depend on them. The current inequalities in access need to be addressed. Once products are registered they should be accessible to all patients. They should be available, adequate, affordable, appropriate and accessible. The question to be addressed is how systems can be changed in order to allow for timely access.

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Nicola Bedlington referred to EPF’s consensus statement entitled ‘Core Principles from the Patients’ Perspective on the Pricing and Reimbursement of Innovative Medicines’ http://

www.eu-patient.eu/globalassets/policy/epf_pricing_statement_160616.pdf, which constitutes the EPF’s contribution to the current debate. It is based on what EPF is being told by its members on a daily basis with respect to the lack of access to innovative medicines as well as to basic care.

EPF provides the patients’ and human rights-based perspective in the debate and advocates for systems that address patients’ needs irrespective of their means.

Nicola Bedlington stated that now is the time for shared responsibility and strong leadership to move forward in this area. There should be a commitment to ethical conduct and solidarity from all stakeholders including industry. EPF intends to be involved in the current and future discussions, injecting an even stronger patients’ perspective, aligning with the Sustainable De-velopment Goals and building on the principles and actions related to universal access.

Elizabeth Kuiper, speaking on behalf of PACT industry partners, welcomed the oppor-tunity of this timely gathering and exchange of views on improving access to healthcare. She outlined three main avenues on how to address this topic with embracing the health technol-ogy sector as a whole, the importance of a continuing open and constructive multi-stakeholder dialogue and bridging the discussions at EU and national level to build on best practices im-proving access to healthcare.

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Audience debate

In the audience debate the following issues were raised:

The meeting’s debate is timely in view of the Council conclu sions, the Dutch presidency focus and the upcoming European Parliament INI report. This report should take account of the views of all stakeholders, including industry and should reach the discussions at EU as well as at Member State level. The focus should be on a transition from cost to outcomes, while addressing health inequalities. Current existing system requires more transparency on the IP and the associated ROI. There is concern across the board about the high prices of medicines and a comprehensive debate needs to take place about value and outcomes. It is hoped that the Commission’s analysis of the situation, as requested by the Council, will be bold and unbiased.

It was recommended for the whole of the health sector to be embraced in the discussions on access – a focus on medicines only is too narrow. Multi-stakeholder collaboration will be indispensable.

There needs to be more consistency in the debates on access to medicines and it would be useful to link all ongoing initiatives, such as the UN meeting on this topic in September, the PACT Regional Conference in September and upcoming G7 meetings. The dots have to be connected and a proper of all debates would be helpful.

Increasing transparency of systems is a must. The EURIPID projects could supply a techni-cal platform for the monitoring of pricing models.

The debate should include a focus on medicines that add value. Medicines might be put on the market at different prices according to patients’ ability to pay.

Governments are involved in pricing and reimbursement systems but also in HTA sys-tems, incentives and investment in research. These three are crucial. So when reviewing the balance of added value and innovation governments also need to be included.

Parallel trade should be addressed.

The potential of adaptive pathways is currently being explored in an EMA pilot project (ADAPT SMART) http://adaptsmart.eu/. Whether adaptive pathways is one of the answers is un-clear; but it could be one new model of how to increase the availability of new medicines to patients.

What the Dutch Presidency has undertaken is useful but more action is needed. All eyes are on the next EU Presidency to take the debate forward to support the Commission in its efforts to progress this issue.

Two stages can be distinguished in the debate (which is new territory): one of informa-tion gathering (on tools and models) and one of decisions where Member States need to answer questions on how to value the medicines. In this respect, Member States may have different views on what constitutes ‘equal’, ‘equitable’ and ‘fair’. Maybe ‘universal access’ is defined differently as well.

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Closing the meeting

Nicola Bedlington stated that the growing political will for cooperation in the field of pharma policy is a positive development which should be supported by the European Commission. We have to ensure the right incentives for medicines development unmet needs and rare diseases. Access to health care is an important pillar for economic growth; a common framework for value assessment would be a great step forward.

At the end of the meeting, a presentation of the pilot project ‘Patient Academy’ was made by

Jana Hlavacova (Civic Association of Young People with MS). This pro-ject aims to ‘professionalise’ patient organisations, providing training in all sorts of skills and activities that are required for effective advocacy in relation to patients’ rights: communica-tion skills, fundraising etc.

The MEP Interest Group on Access to healthcare supports this type project as they are indis-pensable for strengthening the capacity of patient organisations and amplifying their voice.