PHARMACEUTICALS IN THE ENVIRONMENT (PIE)
In recent years, improved analytical techniques have resulted in pharmaceutical residues being detected at low concentrations in the aquatic environment. There is general agreement among scientists in academia, industry and government that, although variable, the levels found are too small to pose any significant risk to human beings or to cause immediate or short-term harm to aquatic life. More information is needed to determine if there are any long-term effects and AstraZeneca is actively involved in this research, as described later in this section.
Our approach
The environmental profile of AstraZeneca’s new pharmaceuticals is assessed prior to applying for government approval and, at a minimum, consistent with applicable regulatory regimes. We are committed to conducting our assessments based upon the best available science, which is continuously evolving. For example, the United Kingdom and Sweden have carried out major reviews of the scientific data relevant to the potential impact caused by pharmaceutical residues in the environment. New Environmental Risk Assessment Guidelines have now been introduced in the European Union and are being revised in a number of other regions, particularly in Canada and Japan. We continue to work with the relevant pharmaceutical industry trade associations to provide expert input to the current public consultations. In anticipation of these new guidelines, and as an element of our internal PIE-related initiatives, we have reviewed the environmental risk assessments for our existing products and, where appropriate, carried out further studies to replace previous default values with measured data.
We are committed to making this environmental risk data, together with available information on our existing products, publicly available via the Swedish Doctors Prescribing Guide, FASS.se website, using the voluntary disclosure system introduced by the Swedish Association of the Pharmaceutical Industry (LIF). A total of 27 substances with environmental data are now included in this database. The system was developed by LIF and a number of Swedish stakeholders, in conjunction with expert representatives from international pharmaceutical companies, convened and chaired by AstraZeneca. In association with the Association of British Pharmaceutical Industries we are also helping the Environment Agency for England and Wales to evaluate the risks of the existing medicines on their priority action list.
In addition, we have introduced an Environmental Risk Management Plan that will accompany all new medicines through the development process and will enable all relevant environmental data to be available at all key decision points.
Our research
Scientists at our Brixham Environmental Laboratory in the UK are at the forefront of research in this field, working both independently and in collaboration with other companies, leading academics and regulatory bodies to advance PIE-related research. We recently invested a further $24 million in new laboratories at the site to improve the facilities for evaluation of the environmental fate and persistence of pharmaceuticals.
As the research moves forward, the understanding of some of the complexities of this issue improves. There was an initial concern that all pharmaceuticals might have long-term environmental effects that were not predictable, by extrapolation, from short-term studies. However, as evidence accumulates it appears that this may only be an issue for a small number of substances that demonstrate ‘atypical’ effects. For example, AstraZeneca has undertaken a full fish life cycle study on tamoxifen that showed significantly less toxicity than might have been predicted for a hormonally acting compound. It also appears that even some closely related substances with the same mode of action can show very different environmental profiles. This has been observed with the beta-blockers, atenolol and propranolol, for example, where atenolol shows significantly lower toxicity to fish compared with propranolol. Our research has also demonstrated that natural photo-degradation, caused by sunlight, can be a powerful factor in the removal of pharmaceutical residues from the environment. For example, there is evidence that around 70% of propranolol can be destroyed this way. It seems, therefore, that all medicines should be evaluated on a case-by-case basis in these respects, rather than being grouped together as a single class or classes.
To eliminate any potential environmental impact, pharmaceuticals ideally would break down rapidly on contact with water. However, to be effective medicines, they must be stable enough to get to the part of the body where they need to be active, without deteriorating along the way. Our increased focus on biological products (which tend to be metabolised by the body or rapidly degraded in the environment) and targeted therapies with shorter treatment regimes will contribute to fewer residues, but balancing the needs of the patient with the potential environmental impact will continue to be a challenge.
Based upon work conducted to date, we have no scientific basis for believing that our manufacturing discharges pose a significant threat to the environment. However, we will continue to conduct internal evaluations for the purposes of identifying future research needs and guiding internal risk management decisions. In the longer term, we will continue to work to ensure that the development and application of our evaluation techniques remains consistent with the evolving science, and that our manufacturing activities remain protective of human health and the environment. One example of our commitment is the commissioning of a $36 million state-of-the-art biological treatment facility at our Avlon Works in Bristol in the UK as well as improving effluent treatment at other facilities.
More information about commitment to managing our environmental impact, and our performance, is available on our website, astrazeneca.com/responsibility.
