Pressure is mounting on European legislators to
introduce tighter regulations at both the European Union (EU) and
national levels on the potentially harmful impact of pharmaceuticals on
the environment. Politicians, environmentalists and even medicines
regulators are calling for action in the face of increasing evidence
that pharmaceutical chemicals used through the whole lifecycle of
medicines from production through to disposal are posing a bigger than
previously anticipated threat to the environment.
There are, however, divided opinions on what needs to be done. Some groups want stricter regulation of production processes, more consideration of environmental issues when market authorisations are granted and more rigorous rules on disposal of pharmaceuticals. Some regulators, environmentalists and fine-chemical producers support suggestions that tougher environmental standards should be applied to imported APIs. This increase in standards could be done by extending rules on GMPs to environmental protection. Others, particularly most parts of the pharmaceutical industry, believe that voluntary initiatives should be sufficient to eliminate the dangers of medicines in the environment.
The European Federation of Pharmaceutical Industries and Associations (EFPIA), representing research-based companies, concedes that the public wants more information about the risks from concentrations of certain medicines in the environment. “We believe that voluntary initiatives might be a relatively fast and flexible way (of dealing with this issue),” says an EFPIA spokesperson.
European countries concerned
The European Commission appears to be taking its time on the issue. The Commission is expected to release shortly a study it has funded on the environmental risks of pharmaceuticals after its publication was postponed last year (1). In 2015, the Commission is scheduled to issue a strategy document outlining ideas for new regulatory measures after which it will have the option to draw up a draft legislation.
Some countries may not wait for specific proposals by the European Commission. Instead they could enact their own regulatory schemes. This effort could happen among groups of states. Countries bordering the Rhine have, for example, already put forward ideas for international regulations to protect the river from pollutants such as pharmaceuticals.
The countries most concerned about pharmaceutical environmental threats are the Scandinavian states, Germany and its German-speaking neighbours. Sweden has been particularly active in lobbying other EU states for new EU regulations to ensure all risks associated with environmentally harmful chemicals are controlled at their source. “This should also, as far as possible, be a principle underpinning the management of environmentally harmful chemicals in medicinal products for human use,” claimed the Swedish Environment Ministry in a policy communication last year.
The Swedish government has also been taking a global perspective on environmental standards in the pharmaceuticals sector. It first proposed several years ago that the EU should move to extend the scope of GMPs to cover environmental protection in the production outside Europe of both finished medicines and APIs.
Environmental research
A lot of the latest research in Europe on the dangers of some pharmaceuticals, including APIs, to the environment has been done in Germany. With the encouragement of Germany’s Environment Ministry (BUMB), the country’s environment agency (UBA) has been conducting or funding studies in areas such as the contamination by pharmaceuticals of soil and sludge through emissions from production processes, sewage and waste-water treatment plants.
In research funded jointly by the UBA and BUMB, IWW Water Centre at Duisberg-Essen University found in an extensive literature investigation a total of 123,761 incidents of measured environmental concentrations (MECs) of pharmaceuticals across the world, according to the results of the study revealed at a workshop in Geneva in April (2). The majority of these were in concentrations in sewage, waste-water treatment effluent and surface water. Only a small minority were found in soil, sediment and slurry.
Altogether, 559 different pharmaceuticals or their derivatives such as metabolites were found in waste-water treatment influent, effluent and sludge, according to IWW. Another 38 different pharmaceuticals were found in surface, ground and drinking waters. The greatest concentration tended to be in Europe and North America. Among the 16 pharmaceuticals most frequently detected in surface, ground and drinking waters, the majority were in Europe, headed by the analgesic diclofenac and the anti-epileptic carbamazepine. With diclofenac, for example, 36 of the 50 detections were in Europe, most of which were in Western Europe.
There are, however, divided opinions on what needs to be done. Some groups want stricter regulation of production processes, more consideration of environmental issues when market authorisations are granted and more rigorous rules on disposal of pharmaceuticals. Some regulators, environmentalists and fine-chemical producers support suggestions that tougher environmental standards should be applied to imported APIs. This increase in standards could be done by extending rules on GMPs to environmental protection. Others, particularly most parts of the pharmaceutical industry, believe that voluntary initiatives should be sufficient to eliminate the dangers of medicines in the environment.
The European Federation of Pharmaceutical Industries and Associations (EFPIA), representing research-based companies, concedes that the public wants more information about the risks from concentrations of certain medicines in the environment. “We believe that voluntary initiatives might be a relatively fast and flexible way (of dealing with this issue),” says an EFPIA spokesperson.
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The European Commission appears to be taking its time on the issue. The Commission is expected to release shortly a study it has funded on the environmental risks of pharmaceuticals after its publication was postponed last year (1). In 2015, the Commission is scheduled to issue a strategy document outlining ideas for new regulatory measures after which it will have the option to draw up a draft legislation.
Some countries may not wait for specific proposals by the European Commission. Instead they could enact their own regulatory schemes. This effort could happen among groups of states. Countries bordering the Rhine have, for example, already put forward ideas for international regulations to protect the river from pollutants such as pharmaceuticals.
The countries most concerned about pharmaceutical environmental threats are the Scandinavian states, Germany and its German-speaking neighbours. Sweden has been particularly active in lobbying other EU states for new EU regulations to ensure all risks associated with environmentally harmful chemicals are controlled at their source. “This should also, as far as possible, be a principle underpinning the management of environmentally harmful chemicals in medicinal products for human use,” claimed the Swedish Environment Ministry in a policy communication last year.
The Swedish government has also been taking a global perspective on environmental standards in the pharmaceuticals sector. It first proposed several years ago that the EU should move to extend the scope of GMPs to cover environmental protection in the production outside Europe of both finished medicines and APIs.
Environmental research
A lot of the latest research in Europe on the dangers of some pharmaceuticals, including APIs, to the environment has been done in Germany. With the encouragement of Germany’s Environment Ministry (BUMB), the country’s environment agency (UBA) has been conducting or funding studies in areas such as the contamination by pharmaceuticals of soil and sludge through emissions from production processes, sewage and waste-water treatment plants.
In research funded jointly by the UBA and BUMB, IWW Water Centre at Duisberg-Essen University found in an extensive literature investigation a total of 123,761 incidents of measured environmental concentrations (MECs) of pharmaceuticals across the world, according to the results of the study revealed at a workshop in Geneva in April (2). The majority of these were in concentrations in sewage, waste-water treatment effluent and surface water. Only a small minority were found in soil, sediment and slurry.
Altogether, 559 different pharmaceuticals or their derivatives such as metabolites were found in waste-water treatment influent, effluent and sludge, according to IWW. Another 38 different pharmaceuticals were found in surface, ground and drinking waters. The greatest concentration tended to be in Europe and North America. Among the 16 pharmaceuticals most frequently detected in surface, ground and drinking waters, the majority were in Europe, headed by the analgesic diclofenac and the anti-epileptic carbamazepine. With diclofenac, for example, 36 of the 50 detections were in Europe, most of which were in Western Europe.
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