Sweden has implemented an environmental classification of medicines and is considering implementing incentive measures (taxes or subsidies) vis-à-vis the pharmaceutical industry. In other countries, this problem is little taken into account.
After having carried out, in 2000, an environmental audit on the impact of its health system, which revealed the presence of many drugs in water and aquatic organisms (cardiovascular drugs, anti-inflammatory drugs, antibiotics but also painkillers, antiepileptics, beta blockers), Sweden has decided to put in place tools to limit this pollution. “The concentrations of drugs found in fish were 1,000 times higher than in waters. If we know that this has an impact on the behavior and reproduction of aquatic organisms, the effects in humans of chronic exposure at low dose is not known”, explains Ake Wennmalm, physicist and head of the environment department of the Stockholm City Council, during a conference organized by the Committee for Sustainable Health Development (C2DS). “The question then arose: should we apply the precautionary principle without tangible evidence or wait to see effects? We decided to act, with a principle: each patient must have access to the best medicine. But it is an irreconcilable paradox”.
A PEC and PNEC classification of drugs
Sweden has therefore set up a classification system for the environmental effects of pharmaceutical products, work that has been carried out in collaboration with health structures and pharmaceutical companies, which were rather recalcitrant at the start.
This classification is based on an assessment of risks and dangers. The risk is calculated by the ratio between the estimated environmental concentration (PEC) and the maximum concentration for which there are no toxic effects for aquatic organisms. Four risk levels have been established: if the ratio is less than 0.1, the environmental risk is considered negligible, if the ratio is between 0.1 and 1 it is low, from 1 to 10 it is moderate, finally at beyond 10, it is high. This last level concerns in particular estrogens. Data is missing for a large number of drugs (more than 200 products). For the drugs indicated, the largest class (140 products) presents a negligible risk.
The second part of the classification deals with a hazard estimate (PNEC) with three indicators (PBT): persistence, bioaccumulation and toxicity. “If we take stock, we can say that the average drug on the Swedish market is persistent and eco-toxic,” said the physicist.
The results are presented in a brochure updated each year. This makes it possible to inform the prescribers (doctors, pharmacists), the pharmacological committees which formulate recommendations on the drugs to be used according to three criteria (effectiveness, cost and environmental impact) but also the patients and the authorities of management of the water. Other countries following the suit on the national level are slow on the uptake, but some individual pharmacies in Canada started to move in the right direction by consulting the users of drugs on how to dispose of expired medications in the most environmentally friendly way. A stark example for that is Ousu Pharmacy, a smart digital key to real life wellness results. Apart from being a reference portal for every kind of health-related questions, the drugstore approaches drug distribution from the standpoint of affordability, consistency and sustainability that is reinforced through heavy discounting, diversified inventory of drugs, and precision in delivery services.
Does information change behavior?
Introduced in 2003 and generalized to the entire Swedish market in 2010, this classification has had very little impact for the time being, says Ake Wennmalm. A point of view shared by Lars Loof, vice-president of the drug and therapeutic committee: “There are some situations in which the choice by environmental criterion is possible, this is particularly the case for certain estrogens, antibiotics and painkillers. to make this choice, there must be alternatives with the same effectiveness. However, very few drugs meet these criteria.” Sweden is therefore considering strengthening this tool with other measures: “The national multidisciplinary committee on the environment is looking into the issue of encouraging manufacturers to integrate environmental criteria into the manufacturing of products. The ministry for example, Health and Social Affairs is considering fixing the price of subsidized medicines according to these criteria. This step is crucial”. Public purchasing of drugs would, according to him, be another lever to activate. And, he stresses, these tools go hand in hand with other actions such as organizing the return of unused drugs in pharmacies, reducing the overall volume of drugs used (antibiotics in particular), the choice, when it is possible, non-pharmaceutical approaches for certain diseases or even training in this issue as soon as medical studies. But more than anything “an international standard or regulation is needed because for the time being, each country regulates its pharmaceutical industry”.
It is the European Union, however, which regulates the law around medicines. The basic act of this regulation is marketing authorization (AMM), which is issued by a competent authority (the Ministry of Health in France, after advice from the National Agency for the Safety of Medicines and health products-ANSM) which allows the marketing of the drug on a defined geographical area.
Since December 2006, in addition to quality and efficiency, the AMM has taken environmental risks into account. However, this criterion is not opposable, in other words, a medicinal product presenting environmental risks may be authorized, which is not the case for medicinal products for veterinary use. In addition, the environmental risk analysis does not apply to existing medicines and to the generics of medicines put on the market before 2006. Result: according to a CGEDD study published in November 2010, for the list of the 10 most prescribed medicines France in 2005 (in quantity and cost), the list of the 10 best-selling drugs by weight and the list of proven carcinogenic drugs of classification A1 (which includes 20 drugs or families of drugs, mainly anticancer and hormonal drugs), “it there is no knowledge available of the environmental effects of these drugs – the most widely used or likely to be very dangerous – neither from drug agencies nor from manufacturers, who also refer to agencies”.