Joint statement of European Pharmaceutical Industry Associations on the European Parliament’s Resolution and on the Strategic Approach to Pharmaceuticals in the Environment
The European pharmaceutical industry, represented by AESGP, EFPIA and Medicines for Europe, welcomes the adoption of the Resolution of the European Parliament on the Strategic Approach to Pharmaceuticals in the Environment (PiE). We see both the Resolution and the Commission’s Strategic Approach to PiE[i], as two complementary tools that will guide stakeholders in their work, in a collaborative approach, to minimise the impact of PiE while safeguarding access to effective treatments for patients in Europe.
The European Parliament’s Resolution includes many synergies with the Commission's Strategic Approach by clearly recognising the added value of industry self-regulatory initiatives[ii]. This is an important signal that underlines industry’s commitment to continue to address environmental concerns through pro-active initiatives such as Eco-Pharmaco-Stewardship[iii], AMR Alliance[iv] and #MedsDisposal[v].
In conjunction with the Strategy and the Resolution, that emphasise the need for further research based evidence to fill in knowledge gaps[vi], recently the industry launched a new IMI project together with public partners called PREMIER. The project addresses several actions proposed by the Commission’s Strategic Approach to PiE, such as identifying potential environmental risks associated with active pharmaceutical ingredients (APIs) earlier in development, or exploring the feasibility of greener drug design.
In view of the forthcoming Pharmaceutical Strategy, we believe that concerns and measures taken to mitigate environmental implications of medicines should not lead to a decrease in patients’ accessibility to medicines caused by any delays in the approval process or even by rejecting authorisation of use.[vii]
We believe that there would be great value for any future proposals addressing the issue of PiE, to take into account best practices already implemented in some European countries. Any designs to address PiE mitigation should be science-based, proportionate and involve all stakeholders along a medicine’s lifecycle.
The European pharmaceutical industry is committed to continuing to work constructively with the European institutions and other stakeholders to deliver tangible progress on PIE so as to improve environmental standards and improve access to medicines.
AESGP, the Association of the European Self-Care Industry, is the representation of manufacturers of non-prescription medicines, food supplements and self-care medical devices in Europe. It is composed of national associations and the main multinational companies manufacturing self-care products. AESGP is the voice of more than 2.000 companies operating in the consumer healthcare sector in Europe, affiliated with AESGP directly or indirectly through the national associations.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. Through its direct membership of 36 national associations, 39 leading pharmaceutical companies and a growing number of small and medium-sized enterprises (SMEs), EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. Our vision is for a healthier future for Europe. A future based on prevention, innovation, access to new treatments and better outcomes for patients.
MEDICINES FOR EUROPE
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe, and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and @medicinesforEU.
[i] The industry’s joints statement on the occasion of the publication of the EU Strategic Approach to Pharmaceuticals in the Environment by the European Commission on 11 March 2019
[ii] § 15 EU Parliament’s Resolution on the Strategic Approach to Pharmaceuticals in the Environment
[iii] 4.2. EU Commission’s Strategic Approach to Pharmaceuticals in the Environment
[iv] Recital O EU Parliament’s Resolution on the Strategic Approach to Pharmaceuticals in the Environment
[v] Recital R EU Parliament’s Resolution on the Strategic Approach to Pharmaceuticals in the Environment
[vi] § 50 EU Parliament’s Resolution on the Strategic Approach to Pharmaceuticals in the Environment
[vii] Recital S, §25 EU Parliament’s Resolution on the Strategic Approach to Pharmaceuticals in the Environment