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Corporate responsibility in the pharmaceutical industry

Corporate responsibility in the pharmaceutical industry

For the pharmaceutical industry to effectively contribute to the health and well-being of EU citizens, industry strategies must be in line with societal needs. The European Commission set up the ‘Process on Corporate Responsibility in the Field of Pharmaceuticals’ to facilitate discussions on ethics and transparency, and on non-regularity conditions for better access to medicines after receiving a marketing authorisation.

The process consisted of three independent platforms:

  • Platform on Ethics and Transparency
  • Platform on Access to Medicines in Europe
  • Platform on Access to Medicines in Developing Countries with a Focus on Africa

Platform on Ethics and Transparency

This platform brought together stakeholders to discuss a joint set of ethical and transparency principles and recommendations based on voluntary cooperation. Its work led to a List of Guiding Principles governing the interactions between healthcare professionals, patients’ organisations, authorities, and the pharmaceutical industry.

Membership

The platform was chaired by the European Commission’s Directorate-General for Enterprise and Industry. EU countries and EFTA countries were invited to nominate representatives from their authorities in pharmaceuticals. The following stakeholders were invited to participate:

  • Bureau Européen des Unions de Consommateurs - BEUC
  • Standing Committee of European Doctors - CPME
  • Pharmaceutical Group of the European Union – PGEU
  • European Hospital and Healthcare Federation - HOPE
  • Association Internationale de la Mutualité - AIM
  • European Social Insurance Platform – ESIP
  • European Federation of Pharmaceutical Industries & Associations - EFPIA
  • European Generic medicines Association - EGA
  • European Self-Medication Industry – AESGP
  • European Association for Bioindustries – EuropaBio
  • European Association of Full-Line Wholesalers – GIRP
  • European Union of Medical Specialists – UEMS
  • European Patients’ Forum – EPF

Steering Group

A Steering Group, chaired by the Commission, was responsible for generating momentum and ensuring the development of the platform. The Steering Group was composed of representatives of the national authorities responsible for the pricing and reimbursement of pharmaceuticals, and of stakeholder representatives. Meetings of the Steering Group were organised in collaboration with each ongoing Presidency of the EU.

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Platform on Access to Medicines in Europe

This platform brought together EU countries and other stakeholders to find common, non-regulatory approaches to the timely and equitable access to medicines in Europe after their marketing authorisation. The members of the platform contributed to various projects. Each project was chaired by the Commission with the support of one EU country.

All the projects were based on voluntary cooperation and partnerships. The experience of the Pharmaceutical Forum has shown that such collaborative, consensus-based approaches can be very successful in this field. Participation in the projects does not commit participants to any future actions outside of the project.

Membership

The platform was chaired by the European Commission’s Directorate-General for Enterprise and Industry. EU countries and EFTA countries were invited to nominate representatives from their authorities in pharmaceuticals. The following stakeholders were invited to participate:

  • European Patients Forum – EPF
  • Bureau Européen des Unions de Consommateurs – BEUC
  • Standing Committee of European Doctors – CPME
  • Pharmaceutical Group of the European Union – PGEU
  • European Hospital and Healthcare Federation – HOPE
  • Association Internationale de la Mutualité – AIM
  • European Social Insurance Platform – ESIP
  • European Federation of Pharmaceutical Industries & Associations – EFPIA
  • European Generic medicines Association – EGA
  • European Self-Medication Industry – AESGP
  • European Association for Bioindustries – EuropaBio
  • European Association of Full-Line Wholesalers – GIRP

Steering Group

A Steering Group, chaired by the Commission, was responsible for generating momentum and ensuring the development of the platform. The Steering Group was composed of representatives of the national authorities responsible for the pricing and reimbursement of pharmaceuticals, and of stakeholder representatives. Meetings of the Steering Group were organised in collaboration with each ongoing Presidency of the EU.

Meetings of the Steering Group

Projects

Mechanism of coordinated access to orphan medicinal products

This project sought to find ways to identify and assess the value of orphan medicinal products for patients and facilitate access to them.

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Capacity building on Managed Entry Agreements (MEAs) for innovative medicines

This project collected quantitative information on existing MEAs, categorised them, and assessed their usefulness in comparison to their financial implications.

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Facilitating the supply of medicinal products in small markets

This project discussed solutions to increase the availability of certain medicinal products. It dealt with issues relating to pricing and reimbursement practices, distribution procedures, and other requirements when placing a medicinal product on the market. The small markets examined were Cyprus, Estonia, Iceland, Latvia, Lithuania, Malta, and Sweden.

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Promoting a good governance for non-prescription drugs

This project examined the role of various actors in ensuring the availability, uptake, and informed use of non-prescription medicines. The final report advocates the significant role that these medicines can play in self-care in the existing framework governing non-prescription medicines.

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Market access for biosimilars

On 6 October 2015, the Commission organised the multi-stakeholder workshop 'Access to and Uptake of Biosimilar Medicinal Products" as a follow-up event to the work carried out with regard to biosimilars during the Process on Corporate Responsibility: Agenda (317 KB), Event report (389 KB), Presentations.

On the occassion of the workshop IMS Health launched the first yearly update on the 'Impact of Biosimilar competition' (464 KB). The report was prepared in close co-operation with the European Commission and the stakeholders. To facilitate the understanding of the report, IMS prepared a short document with a few observations (287 KB) and a reading guide (266 KB).

During the Process on Corporate Responsibility, the working group 'Acces to and Uptake of Biosimilars' took stock of the availability of biosimilar medicinal products in national markets and defined the conditions for their informed uptake and adequate patient access.

In the margins of the project, the European Generic Medicines Association (EGA) conducted a survey to identify good practices and obstacles to the uptake of biosimilar medicines in EU and EEA countries. The survey demonstrated the need for clear and unbiased information from an independent source. This information should target all stakeholders on the scientific concept of biosimilars, their approval process, and their safety and efficacy. The consensus information document "What You Need to Know about Biosimilar Medicinal Products" (1 MB) is intended to help serve this purpose.

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Please note that that the answer on how to find the relevant information on biosimilar medicines on the European Medicines Agency (EMA) website in the Consensus Information Document (questions 11 and 12 of the Q&A for Physicians) is outdated. Information on biosimilars can be found on the  EMA webpage.

Prioritisation

The purpose of the "Priority Medicines for Europe and the World" report is to study pharmaceutical innovation from a public health perspective, and to prepare a public-health-based medicines development agenda. The Prioritisation working group was mandated to guide the revision of the report in association with EU countries, the Commission, and stakeholders.

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Platform on Access to Medicines in Developing Countries with a Focus on Africa

The goal of this platform was to reflect on the contributions stakeholders can make by pooling their resources in Africa, and more specifically in the sub-Saharan region. Following an informal workshop with international experts and other stakeholders, two projects were launched in close cooperation with the Commission.

Membership

The platform was chaired by the European Commission’s Directorate-General for Enterprise and Industry. EU countries and EFTA countries were invited to nominate representatives. The European Commission also asked the African Union Commission to contribute. The following stakeholders were invited to participate:

  • European Patent Office
  • World Health Organization
  • United Nations Industrial Development Organization
  • United Nations Conference on Trade and Development
  • World Intellectual Property Organization
  • International Patient Alliance (Reginal group Africa)
  • Medicines Patent Pool
  • Médecins Sans Frontières
  • Global Fund
  • International Federation of Pharmaceutical Manufacturers & Associations Germany
  • European Federation of Pharmaceutical Industries & Associations
  • European Generic medicines Association
  • European Association for Bioindustries
  • European Association of Full-Line Wholesalers
  • SME Pharmaceutical Entrepreneurs Association
  • East African Pharmaceutical Manufacturers
  • Southern African Generics Association
  • South African Generics Medicines Organization
  • African business associations

Projects

Patent Information System

Transparent and accessible data is important for the research, development, and procurement of medicines. This project sought to improve the availability and access to patent information through an expert search and analysis of augmented patent data. A pilot project with one compound (GS7977, a Hepatitis C pipeline drug) was carried out.

The final report considered the establishment of a database of expert reviewed, indexed, and classified patent information relating to certain medical products in Sub-Saharan Africa.

Documents:

Terms of reference (22 KB)

Final report (847 KB)+ EPO results (47 KB)

Local Capacity Building

The aim of this project was to explore how to support the building of capacities for medicines, i.e. distribution channels, local production, clinical trials etc. The intention was to foster a comprehensive approach beyond manufacturing including in areas such as the quality of products and testing. The following areas were identified as worth further exploring:

  • Good manufacturing practices / good clinical practices / good laboratory practices
  • Pharmacovigilance
  • Distributing / dispensing of medicinal products
  • Regulatory environment including its enforcement
  • General lack of relevant skills

As a result of the project, the European Commission organised an EU-Africa Pharma Business to Business Forum: An exchange of views between regulators and business community from Europe and Africa. This took place on 16 September 2013 in Brussels. The Forum's main objective was to give an overview of obstacles related to responsible business relations and reach a consensus on how European stakeholders could best share technical knowledge with their African counterparts.

Documents (62 KB)

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