Proactive Policies

As our global populations grow and the demographics of the developed world change, the pharma industry is beginning to feel the strain. The pharmaco-economic burden of catering to the healthcare needs of the masses is spiraling, but the European Medicines Agency (EMA) is not idly standing by.

The environment at risk

Twelve years after the release of the original document, the EMA has published a revised version of its “environmental risk assessment (ERA) of human medicines” for a 6-month public consultation. The purpose of reissuing the document was to help clarify when ERA studies are required and improve the consistency of these assessments (1).

Biologically-active pharmaceuticals can enter the environment in a number of ways, including through manufacturing discharge, human use, and inappropriate disposal, and have been shown to directly affect wildlife. As one example, the API in the contraceptive pill has been found to feminize some male fish. The guideline aims to protect aquatic and terrestrial ecosystems including surface water, groundwater, soil and secondary poisoning, as well as microbial communities in sewage treatment plants. In Europe, an ERA is mandatory for any pharma company submitting a marketing authorization application and should be based on “the use of the product and the physico-chemical, ecotoxicological, and fate properties of its active substance.”

The revised guidelines include:

• A detailed decision tree to provide more thorough technical guidance to applicants.

• Introduction of the term “endocrine active substances” to include all compounds that affect development or reproduction.

• Additional guidance on secondary poisoning (the exposure of predators to pharmaceuticals through the food chain).

• Suggestions to limit laboratory test methods to reduce the burden of testing on applicants.

The guidelines also encourage applicants to share data generated for the ERA to avoid the repetition of studies.

Stakeholders wishing to comment on the guidance must do so by June 30, 2019. Further details are on the EMA’s website (1).

Emergency protection

The Spanish Flu outbreak of 1918 affected lives on a global scale. One hundred years later, despite advances in healthcare and pharmaceutical interventions, the threat of cross-border disease outbreaks still looms. The last decade – with outbreaks of H1N1 virus, Ebola and Zika – has proven just how real and present the danger is.

In line with its strategy for 2022, the EMA has prioritized planning for, responding to and communicating on serious health topics, and has published a plan of how the agency would respond to health emergencies, whether it be infection, chemical, environmental or “of unknown origin”. Building upon the 2006 pandemic influenza plan, the document reflects upon information gained during the 2009 influenza pandemic and the 2014 Ebola crisis to ensure readiness in dealing with emerging health threats (2). Some of the key aims of the plan are:

• To initiate and coordinate scientific and regulatory activities by involving all interested parties within the EMA and the European Medicines Regulatory network.

• To manage and coordinate the discussions on development, authorization and surveillance of relevant medicinal products, such as vaccines and antivirals for pandemic influenza.

• To effectively communicate relevant information to healthcare professionals, patients and regulatory partners.

• To provide support to international partners, such as stakeholders involved in the research and development of medicinal products, as required.

The document outlines three different levels of health threat plan, which translate into different levels of EMA staff involvement; Level 4 represents the highest level of threat (pandemic). The processes stress the importance of continued and frequent dialogue within the European region and industry. Though the plan details the regulatory activities that the EMA would initiate during a disease outbreak, it does not cover how manufacturing issues related to specific medicines would be dealt with.