On 10-11 November the Medical Products Agency hosted a European Conference on “Sustainable Development and Pharmaceuticals”. EU environmental and health authorities, the Commission, Parliament, the European Medicines Agency EMEA, industry and academia attended the meeting which took place in Uppsala.
The conference presentations were interspersed with group discussions, which resulted in an informal and constructive working atmosphere.
State Secretary of The Ministry of the Environment, Elisabeth Falemo, stated in her opening speech the importance of all three dimensions of sustainable development, the social, economic and environmental concerning pharmaceuticals. The State Secretary expressed a wish for pharmaceuticals to be viewed from a lifecycle perspective in the future.
MistraPharma presented a Swedish world-unique research project on the environment and pharmaceuticals that focus on both identifying the most problematic drug substances, and on finding solutions to problems.
Representatives from the pharmaceutical industry pointed in their presentations to the importance of working from a broad perspective of sustainable development exemplified in the development of green chemistry and the reduction of the carbon dioxide footprint.
The EU Commission's priority for pharmaceutical and sustainable development lies in the areas of antibiotic resistance, endocrine disrupters, and the question raised during the Swedish Presidency how people are affected by all the different chemicals they are exposed to, including pharmaceuticals.
The European Parliament, represented by the Green party group, said that the pharmaceutical industry lags behind the chemical industry in its environmental work. They pointed specifically to the practice that the absence of data is not the same as a substance not having environmental impact.
The European Medicines Agency, EMEA, said that although the assessment of environmental risks must be made, a medicinal product intended for humans use can never be denied an approval, because the law states that the benefits of the medicine always takes precedence over any environmental risks. The legislation deals with the issue by in case of identified environmental risk making the industry propose measures to reduce it.
All participants agreed that there are problems with pharmaceuticals in the environment. India was highlighted as an example where very high concentrations of drug compounds could be found in drinking and groundwater in areas with many pharmaceutical industries. There are also signs that this is not an isolated case, but it appears in several places in the Third World, which indicates that the problem is global.
The emissions in question are also associated with an increased risk of antibiotic resistance, which includes the background to the Swedish government's commission to the Medical Products Agency to investigate the possibility of stricter legislation in the field. The commission is to be reported to the government by 31 December.
Another problem that was identified and discussed during the conference was the lack of relevant data on the effect of pharmaceuticals in the environment, particularly with regard to drugs approved prior to the 2000s. One conclusion of the meeting is that the experience of the Swedish environmental classification system also could be used at an EU level.
It was gratifying to see the constructive spirit among the participants and a willingness to discuss a way forward. A number of possible actions were discussed. Among other things, how to deal with lack of data and how the supply chain better can ensure that suppliers work on a sustainable basis. From the discussion it was clear that much work remains, but through this conference we have a good staring point because of the openness and cooperation shown by all participants during the meeting.