Assessing the environmental risks of a new medicine as part of the risk–benefit assessment during market authorisation would be “catastrophic” for the pharmaceutical industry, an environmental scientist from manufacturer AstraZeneca has said.
Jason Snape, senior principal environmental scientist at AstraZeneca, spoke about the impact of pharmaceuticals on the environment at the autumn conference for the Procurement and Distribution Interest Group of the Guild of Healthcare Pharmacists, held on 26 November 2019.
He said that both the Organisation for Economic Co-operation and Development (OECD) and the European parliament “are advocating bringing environmental hazard — environmental risk — into the patient-benefit analysis of medicine”.
This would mean the environmental hazards related to a medicine “could be a point of denial or a point of delay to new medicines coming to market,” he explained.
In March 2019, the European Commission published the ‘EU strategic approach to pharmaceuticals in the environment’, in which it noted that environmental risk assessments are already mandatory for marketing authorisations in human medicines, but they are not part of the patient–benefit analysis. This only applies to veterinary medicines.
The OECD added in a report — ‘Pharmaceutical residues in freshwater: hazards and policy responses’, published in November 2019 — that the lack of consideration around environmental impact in the benefit–risk balance is considered one of “the limitations of current practices” for environmental risk assessments in the authorisation of human medicines. It therefore concluded that governments should “consider environmental risks in risk-benefit authorisation of human pharmaceuticals”.
However, Snape said if regulators “bring a denial in because it has environmental risks or hazards on to authorisation, that’s catastrophic for the economic sustainability and viability of our industry”.
“If we have a ‘green’ medicine at the moment, it’s not by design — it’s by complete accident because we don’t do any environmental impact assessment on our medicinal products until phase III clinical trials; once the patient safety and patient efficacy has already been done.”
Snape added that this is “typically when we’ve invested somewhere in the region of about £600m on that medicine”.
He said AstraZeneca is currently researching “the options for a greener drug design”.