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’ (2010-2103) 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:
After the finalisation of this process, and in response to the interest expressed by stakeholders for some of the topics previously discussed, the European Commission organises multistakeholder meetings on "Follow-up activities related to Corporate Responsibility in the field of Pharmaceuticals" in order to facilitate the exchange of information on policies relating to pricing and reimbursement of pharmaceuticals.
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.
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:
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.
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.
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:
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.
This project sought to find ways to identify and assess the value of orphan medicinal products for patients and facilitate access to them.
This project collected quantitative information on existing MEAs, categorised them, and assessed their usefulness in comparison to their financial implications.
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.
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.
During the 'process on corporate responsibility', the working group on 'access to and uptake of biosimilars' took stock of the availability of biosimilar medicinal products in national markets. The group also defined the conditions for their informed uptake and adequate patient access.
They identified clear and unbiased information from an independent and reliable source as one of the key elements for adequate and informed uptake of biosimilar medicines. The 2013 document on biosimilar medicinal products informs all stakeholders on the scientific concept of biosimilars, their approval process, and their safety and efficacy.
Specific and recently revised information on biosimilars for patients is available in the 2016 document on biosimilar medicines. In 2017, a new information guide for healthcare professionals was published in cooperation with the European Medicines Agency.
A recent report conducted by QuintilesIMS on behalf of the European Commission gives insights on the impacts of the increased biosimilar competition in Europe.
Follow-up activities to the ‘process on corporate responsibility’:
Multi-stakeholder workshop 'access to and uptake of biosimilar medicinal products'
Second multi-stakeholder workshop on biosimilar medicines
Third multi-stakeholder workshop on biosimilar medicines
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.
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.
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:
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)
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:
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)