On 25 November, the European Commission published its new EU Pharmaceutical Strategy. Learning from the COVID-19 crisis, the strategy intends to set out a plan for a future-proof and crisis-resilient EU pharmaceutical system relying on 3 pillars:
- ensuring that patients have access to affordable medicines
- supporting the competitiveness, innovative capacity,
- finding the necessary link for more sustainability, crisis preparedness and response and building a strong EU voice in the world in the EU pharmaceutical industry.
Both in our response to the public consultation (available here, with its accompanying additional remarks) and during the latest EU Social Partner meeting with Vice-President Magaritis Schinas and Commissioner Stella Kyriakides, CEEP urged the European Commission to respond accordingly to the challenges of the environmental impacts of pharmaceuticals, and for a linking up with the Zero Pollution Action Plan, as well as to the approach to Pharmaceuticals in the Environment (PiE). CEEP welcomes that this aspect has been taken into account and will hopefully make the necessary changes where it is needed.
The strategy stresses that a more sustainable pharmaceuticals sector is important to reach the objectives of the EU Green Deal. Actions are required throughout the lifecycle of medicines to reduce emission levels, resource use and the levels of pharmaceutical residues in the environment. The strategy recognises that innovation for environmentally sustainable and climate-neutral pharmaceuticals and manufacturing should be a driver, and highlights the need to improve the waste of unused medicines. CEEP regrets the lack of a direct response to the unsustainable problem on the End-of-Pipe solutions. Making the pharmaceutical strategy more environmentally friendly would have required to take the precautionary principle and the control-at-source principle into account, whilst the financing of measures be primarily based on the polluter pays principle.
A progress review on the PiE has also been published along with the strategy. It shows that good progress has been made in implementing the different actions. Most of the actions have already started and are currently ongoing, whilst other have been completed with the Urban Waste Water Treatment Directive (UWWTD) identifying an issue with pharmaceuticals in waste-water. The Commission is now considering appropriate follow-up in the form of an impact assessment and a possible revision to these findings.
Additionally, a feasibility study on extended producer responsibility (EPR), including in the pharmaceuticals sector, is planned as part of the impact assessment on the potential revision of the UWWTD, with a follow-up to be done on the REACH evaluation and the Fitness Check on the Chemical Strategy.
The Strategy will be one of the main items to be discussed at the political level at the “Employment, Social Policy, Health and Consumer Affairs” meeting of the European Council on 2 December. Once approved, the implementation of the various actions, communications and evaluations foreseen will start immediately. It will translate into both legislative and non-legislative actions, and intends to strictly follow the rules under the Better Regulation principles via impact assessments and public consultations.