Vision and Mission

The Rational Use of Medicines

7 June 2013

 

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Contents

Executive Summary

The Piperska Group is a multidisciplinary network of professionals who share the common vision of enhancing the health of the public and the individual patient in a sustainable way through exchanging ideas and co-operation around the rational use of pharmacological and related therapies. The group focuses on the managed introduction of medicines, building on an acquired body of knowledge, on its members' experience, and on evidence-based research methods. It addresses the problems that our societies are facing in maintaining and improving their health care systems.

In many European countries, pharmaceuticals constitute the biggest sector of health care spending. Given that costs have risen by 50 % between 2000 and 2009 in the OECD countries, the importance of implementing rational strategies to guide further development is evident.

The Piperska Group pursues research and translates evidence-based results into policy making. Its activities are geared towards producing results ready to be employed by European and national policy makers in order to achieve their agenda of building tomorrow's health care systems.

The group is comprised of researchers, practitioners from national institutions all over Europe, and patients' representatives, all of whom are independent from industry interests.

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1 Introduction

The European ideal encompasses, amongst other things, universal access to comprehensive and equitable health care for all citizens. The members of the Piperska Group recognise that the constant launch and utilisation of new expensive medicines represent both a major opportunity and a major challenge to the fulfilment of this vision. They also recognise that new competencies and collaborations are needed across Europe to adequately address this challenge.

Due to these considerations, the Piperska Group was formed as a multidisciplinary network of professionals who are actively involved with initiatives to enhance the rational use of medicines and related therapies. Its aim is to provide guidance principally on improving the managed entry of new medicines around the three pillars of pre-, peri- and post-launch activities. Furthermore, reimbursement decisions should be based on need, usefulness, and evidence. This was illustrated in the agreed vision of the first meeting in Stockholm 2008: “To ensure robust systems are in place in Europe, to enhance the rational use of technologies, especially new, expensive medicines, in order to improve health”.

A major strategy has been to provide a networking forum to enable European countries to collaborate with and learn from each other. This was achieved through a pan-European network to exchange ideas about research and best practice and to co-operate on joint activities, leading to joint educational courses and publications. The target audience, in addition to researchers, are European and national policy makers, to whom it provides guidance on these important issues.

After several years of intensive activities, a common understanding of the vision, mission, and shared values of the group has been established. These are placed in this programmatic statement of the group in order to ensure a transparent, sustainable and effective organisation. Central to the group's efforts will be educational activities including courses, continued publication of peer-reviewed papers, and initiatives to obtain funding for agreed activities. The rationale behind the formation of the Piperska group is described in the appendix.

Members of the Piperska Group benefit from a free exchange of ideas with interested colleagues from different organisations from all across Europe, as well as practical research and advice on potential ways to further enhance the rational use of medicines, particularly new, premium priced pharmaceuticals, in their own countries.

Consequently, the Piperska Group envisages to be recognised as the leading pan-European platform for the countries involved to achieve their aims in accordance with the group's vision.

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2 Vision and Mission of the Piperska Group

2.1 The Piperska Group's Vision

The Piperska Group is a multidisciplinary and multitask network striving to enhance the health of the population and the individual patient in a sustainable way through exchanging ideas and co-operation. It provides European thought leadership for the rational use of pharmacological and related therapies.

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2.2 The Piperska Group's Mission

The Piperska Group recognises that it is important to bring about changes in attitudes, as well as new competencies and systems, to achieve this vision. As a consequence, the group fosters research and training on how further to enhance the rational use of medicines through co-operation, exchange of ideas, and strategic discussion of key issues.

Furthermore, the group continues to develop, evaluate, and publish on new models centred on the three pillars of managed entry (pre-, peri- and post-launch) which support reimbursement, funding, and availability of new medicines whose therapeutic value has been demonstrated. At the same time, the group discourages funding where there are concerns with the safety, effectiveness, and/or value of new medicines. The group also organises interventions which improve the rational use of medicines after their launch.

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2.3 The Piperska Group's Goals

The Piperska Group recognises that in order to fulfil its mission it must adopt a multi-faceted approach. Consequently, the medium and long term goals are:

  • To define and publish on suggested models (building on existing knowledge and publications) in order to improve the managed entry of new medicines based on the three pillars of
    • pre-launch activities, including horizon scanning and estimating budget impact,
    • peri-launch activities, including critical evaluations of medicines,
    • post-launch activities, including registries and indicators on quality and efficacy.
  • To improve the rational use of medicines in general, including delisting of those whose use is no longer justified through scientific evidence.
  • To disseminate ideas providing guidance to national governments, health care agencies, and organisations like WHO and EMA on
    • issues of pre-registration and registration especially around phase III comparative studies,
    • aspects of reimbursement of medicines, including equitable access,
    • pharmacovigilance, including real-world studies of both effectiveness and safety.
  • To maintain and enhance an active and multidisciplinary pan-European network of researchers, healthcare professionals, and patient representatives in order to exchange ideas and knowledge on ways to improve the rational use of medicines, particularly new pharmaceuticals.
  • To strengthen joint activities between countries on ways to improve the rational use of orphan drugs and targeted therapies, recognising that resource pressures are growing.

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2.4 The Piperska Group's Domains of Activity

The Piperska Group focuses on activities like the following in order to meet its Vision and Mission:

  • Developing methodologies to improve the managed entry of new expensive medicines including new targeted therapies and incorporating ways to improve the interface management
  • Strengthening early assessments of the potential therapeutic value as well as potential safety concerns of new chemical entities in order to guide key decision makers.
  • Co-ordinating shared activities surrounding orphan drugs to optimise their use and reduce off-label use.
  • Researching ways to enhance the rational use of established medicines building on ongoing activities, thereby sharing, for instance, knowledge about demand-side approaches and their influence.
  • Further developing indicators of quality, efficiency, performance, and safety for both new and established medicines.
  • Producing cross-national comparisons identifying common challenges and best practices for addressing them.
  • Developingand refining ways to improve the interface across different health care settings, in particular between primary and secondary care.
  • Encouraging establishment and maintainenance of drug utilisation databases and patient registries providing the necessary empirical foundation for evidence-based research.
  • Frequently publishing papers in peer reviewed journals, based on the group's original research and utilising the experience and databases of its members.
  • Holding one annual meeting per year and at least one training course every three years.
  • Regularly undertaking educational courses, symposia, and workshops on potential ways to improve the rational use of medicines.
  • Recruiting new members who can help the group achieve its goals, aiming to represent both the patients' perspective and as many European countries as possible.
  • Strengthening interactions with key bodies including the EMA, WHO, PPRI, and pertinent scientific organisations.
  • Seeking to collaborate with other groups, such as MEDEV, in order to coordinate strategies and activities, with the potential for joint meetings to reduce the burden on persons that are members of both groups.
  • Actively maintaining and updating a website that informs key stakeholders about the group, including its Vision and Mission, its activities, members, and potential educational courses as well as links to other websites relevant to the group's field of interest.
  • Identifying potential funding sources and applying for grants to support the group's activities, including open access publishing and funding for a part-time co-ordinator to help achieve the sustainability of the Piperska Group.

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2.5 Values of Piperska Group Members

The Piperska Group members actively endorse these values:

  • To keep the patients' welfare at the focus of activities.
  • To be independent of the pharmaceutical industry and other commercial activities.
  • To base positions, evaluations, and recommendations on facts, evidence, and the best scientific practice available.
  • To be open to new ideas, new developments, differing points of view, and different needs.
  • To endorse actively scientific interest in researching and to evaluate initiatives to enhance the quality and efficiency of prescribing of both new and established medicines, either regionally, nationally, or across Europe.
  • To exchange openly ideas, knowledge, and experiences as well as to co-operate in research projects including cross-national research projects.
  • To prefer open access publishing of materials in order to support widespread dissemination of results.
  • To continue to be multidisciplinary, with members learning from each other and keeping close links with key stakeholders at a pan-European, national and/or regional level.

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3 Structure of the Group

A flexible structure is needed to maintain the ethos of co-operation among members interested in exchanging knowledge and co-operating on research activities. The agreed rules include:

  • Members must seek their own funding to attend annual and other joint meetings.
  • Members must be from
    • health authorities or health social insurance companies (national or regional),
    • academic units, universities or other bodies actively involved with activities to enhance the rational use of medicines,
    • independent patients' organisations,
    • other bodies (including medicines agencies) which are actively involved in either registration or decisions on reimbursement, pricing, and funding of medicines.
  • Direct employees of pharmaceutical companies or persons in conflict of interest with the values and goals of the Piperska Group cannot become members.
  • Any involvement of individual members in the pharmaceutical industry or other commercial activities must be formally and openly declared in a list of interests, and members will not take part in activities where a conflict of interests may arise.

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Appendix: Rationale behind the Formation of the Piperska Group

Managing the utilisation of new medicines is one of the major challenges which health care services throughout Europe are facing. Pharmaceutical companies continuing to launch new expensive pharmaceuticals at high acquisition costs have increased these challenges. This has happened in spite of the observation that most new products have only limited health gain over previously established standards.

European countries have typically introduced a range of measures to enhance the quality and efficiency of prescribing of established medicines. The resources released are used to help maintain comprehensive and equitable healthcare in Europe within finite budgets.

It is recognised that no European country has found the perfect model to improve the introduction of new pharmaceuticals or to enhance the rational use of established medicines. Consequently, countries need to learn from each other through active networks and collaboration on research activities.

Recognising these common needs, 33 leading healthcare professionals from nine EU countries met for two days in Stockholm in January 2008. The Karolinska Institute and the Stockholm County Council hosted the meeting, with input and expertise from leaders from the Mario Negri Institute for Pharmacological Research, Milan, the Catalan Institute of Public Health, Barcelona, and the universities of Heidelberg, Liverpool, Lyon, and Marseilles. The delegates were multidisciplinary and included representatives of health authorities, academic units, regulators, and universities involved in registration, reimbursement, formulary listing, and funding decisions as well as initiatives to enhance rational prescribing. The meeting was held at the Piperska Muren conference centre, whence the group decided to take its name.

The initial organising group consisted of Vittorio Bertele', Silvio Garattini, Brian Godman, Lars L Gustafsson, Alan Haycox, and Björn Wettermark. It was a deliberate policy of the members present not to seek external funding initially in order to ensure the free exchange of ideas from this diverse group, with no conflicts of interest governing decisions on proposed activities and publications.

The group agreed that common goals and objectives could best be achieved through actively sharing ideas, experiences, methodologies, and initiatives, building on the strong foundation of independence and evidence-based values. Moreover, the members accepted that active networks of scientists, decision makers, and advisers from all across Europe could best work towards new legislation and initiatives to enhance the rational use of medicines.

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