October 27, 2014 by David Taylor
A fascinating meeting took place in Brussels last week when the three trade associations involved with pharmaceuticals EFPIA (European Federation of Pharmaceutical Industries and Associations), GA (European Generic Medicines Association) and AESGP (Association of the European Self-Medication Industry), who do not frequently work together held a debate on this issue with the biggest environmental NGO concerned with healthcare HCWH(Healthcare Without Harm). This represented a risk for both parties who have very different viewpoints and perhaps not surprisingly they had taken the precaution of obtaining the services of a neutral moderator, although his skills were not really needed.
Approximately 70 people had been invited from a wide range of stakeholders: trade associations, environmentalists, academics, health professionals, regulators and commission staff. The meeting took a slightly unusual form: after brief introductions there were three sessions involving panel discussions with the involvement of the wider audience. Each panel member was given 5 minutes to make their points and then there was a further 60 minutes for further discussion.
The meeting was opened by a welcome from the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Richard Bergstrom and the Executive Director of Health Care Without Harm (HCWH), Anja Leetz. Both welcomed the opportunity for engagement and sharing of views to promote better understanding. There was agreement that both groups have the same objectives but the industry has very different ideas to HCWH as to how this might best be achieved.
These introductions were followed by introductory remarks about the European Commissions proposed strategic approach to PIE from Commission Officials, Araine Vander Stappen representing DG SANCO and Helen Clayton representing DG ENV. The Commission is proposing to base its strategy on the conclusions of the recently published BIO intelligence service report, and were working to a timetable that would have a strategy agreed by September 2015 and fully implemented by September 2017.
PANEL 1: Managing environmental criteria in R&D, manufacturing and supply chain.
The two key questions to be addressed were about discharges from manufacturing and the proposal to incorporate some environmental aspects into GMP. The panel consisted of the following speakers:
• EFPIA (Dan Caldwell)
• University of Gothenburg (Joakim Larsson)
• RIVM, Rijksinstituut voor Volksgezondheid en Milieu (Ton Breure)
• MPA, Medical Products Agency in Sweden (Kia Salin)
• EGA, European Generics Medicines Association (Andreas Hartmann)
The speakers from RIVM, Swedish MPA and the University of Gothenburg all expressed their concern that manufacturing plants in many parts of the world had been shown to produce high concentrations of APIs in effluent discharges, that there were no specific API limits set for effluent discharges and no transparency about releases. The main concern was with potential antibiotic resistance caused by these discharges. The speakers considered that the industry had a responsibility for the effluent discharges of their outsource contractors, they should publish all data on effluent concentrations and accept GMP criteria as part of their product stewardship obligations.
The speakers from EFPIA and EGA described the current activities of the industry to control the release of pharmaceuticals in manufacturing effluent discharges, describing the new life cycle based Eco-pharmacostewardship guidance that had just been agreed by the three trade associations. Neither speaker felt that inclusion of environmental conditions in GMP was appropriate or necessary.
PANEL 2: Use of Pharmaceuticals
In this session there were three issues to be considered: Environmental Risk Assessment of pharmaceuticals, Doctors prescription practices and the Environmental classification of medicinal products. The four panel members were:
• EFPIA (Bengt Mattson)
• CPME, Comité Permanent des Médecins Européens (André Herchuelz)
• Stockholm County Council (Åke Wennmalm)
• UBA, Umwelt Bundesamt (Nicole Adler)
The speakers from UBA, SCC and CPME were concerned that the current ERA process needs to be improved, all existing compounds need to be assessed and all the data should be made publically available preferably in a series of substance based monographs. Both the UBA and SCC speakers felt that the ERA information should be taken into account in the Marketing Authorisation, although Åke Wennmalm considered that this should never deny the availability of essential medication for patients. He was also of the opinion that Environmental Classification Schemes could provide useful information to doctors.
The EFPIA speaker described the newly agreed Ecopharmacostewardship procedure part of which was intended to significantly improve the ERA process. He also stated that some companies were already placing all their ERA data in the public domain and that more would follow. He was adamantly opposed to the inclusion of ERA data in the Marketing Authorisation but indicated that post approval activities were now part of the industry Ecopharmacostewardship approach.
PANEL 3: Disposal of Pharmaceuticals
This part of the debate was primarily about the issue of unused medicines and was concerned with disposal practices in different countes/infrastructures and possible harmonisation of collection schemes at EU level. The panel consisted of five speakers, two of whom had direct experience of national schemes, VALORMED in Portugal and CYCLAMED in France.
• PGEU, Pharmaceutical Group of the European Union (John Chave)
• Valormed (Raquel Gomes da Silva)
• LEEM, Les Entreprises du Médicament (Romain Journel)
• EUREAU (Anders Finnson)
• noPills Project (Issa Nafo)
There was universal agreement that unused pharmaceuticals should not be flushed down the drain and most people agree that collection schemes co-ordinated via pharmacies are a sensible approach. It was however pointed out that there is evidence that simply implementing a scheme is insufficient and effective schemes usually require active encouragement of the participants.
Despite the fact that the pharmaceutical directive requires Member States in the EU to establish such schemes nationally, there are a wide range of situations from Best Practice schemes such as VALORMED/CYCLAMED to no schemes at all in about half of the member states. DG SANCO will be issuing a revised directive on veterinary medicines which will have more specific wording in the relevant clause. There was general agreement that whilst a prescriptive regulation was inappropriate the EC should ensure that the current directive was implemented.
The fact that the meeting took place at all was probably more interesting than the actual content. The size of the audience precluded an actual debate and consequently most of the input consisted of people stating their current positions, without seeking to achieve a common endpoint. However, it may have achieved its purpose simply by getting people in the same room to air their views and concerns.
From our blog
August 14, 2017 by Becky Marks