Joint press statement of European Pharmaceutical Industry Associations on the European Parliament’s Resolution 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.
References
[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