PDA Manufacturing Meets Legislation

[Author’s note: For those who missed the Manufacturing Meets Legislation Workshop, we have compiled a short article summarizing some important points that came up during the sessions and discussions in between. We chose to focus on two main topics: Sustainability and PFAS.]

There is one thing certain about the topic of sustainability, is It has come to stay!

Sometimes, topics just come and go, so it might be a good strategy to just wait and see. However, this is different regarding sustainability because this topic has such a global impact and is on the agenda of basically all industries (the skeptics in the pharmaceutical industry have to realize by now that it has come to stay). This is evident by the sheer number of regulations that have come into force and are being developed globally – like the known Registration, Evaluation, Authorization and Restriction of Chemicals regulation regarding requirements on timber, deforestation, waste management, microplastics, supply chain due diligence and many more.

“We are moving from reporting requirement to action-led requirement”

Marion Briggs, Airfield Consulting

Times are over when green claims can just be made without any data to back them up. You may have realized it got a bit quieter around these green claims recently. In April 2024, the Committee on the Environment, Public Health and Food Safety of the European Parliament published a proposal for a regulation (COM (2023)0193 – C9-0144/2023 – 2023/0131(COD)), which includes the term “environmental risk” 37 times. For example, amendment (25)/33a suggests, “Marketing authorization should be granted by the Commission only after a single scientific evaluation procedure addressing the quality, safety and efficacy of high technology medicinal products has been conducted by the Agency, applying the highest possible standards and the completion of an environmental risk assessment.” This means that in a worst-case scenario, your approval can be refused if your environmental risk assessment does not satisfy the requirements. A web portal is suggested, where all relevant information should be stored transparently. In addition, an ad hoc environmental risk assessment working party should be established within the Emergency Medicines Agency. This underscores how serious this topic is.

In all areas, the industry is looking into how to address this topic - Pharmacopeia and ISO are investigating how sustainability can be included. We are not talking about the good old ISO 14001:2015 Environmental Management Systems — Requirements with Guidance for Use; we are talking about the specific primary packaging chapters and standards. Pharmaceutical companies are putting sustainability topics on the procurement agenda. For Novo Nordisk, for example, sustainability is a minimum of 10% of the criteria in tenders. According to Joachim Almdal, Green Innovation Group A/S, AstraZeneca, GSK, Novo Nordisk and Amgen have already achieved a minimum reduction of 46.2% of CO2e emissions in scopes 1 and 2.

With all these upcoming regulations, we want to avoid an overload of different regulations worldwide. So, at the same time, there is an effort to harmonize the standards, the reporting and the requirements on a global level. Some examples include the Corporate Sustainability Reporting Directive, the European Sustainability Reporting Standards, the International Sustainability Standards Board and the International Financial Reporting Standards.

Per- and Polyfluoroalkyl Substances

Another hot topic in the industry is the global discussion around the restriction actions related to the per- and polyfluoroalkyl substances (PFAS). The world was made aware of these substances back in 2023 when the European Chemical Agency (ECHA) drafted a wide restriction for these substances. The restriction aims to limit the risks to the environment and human health from the manufacturing and use of a wide range of PFAS since they accumulate and do not naturally break down. It is the most complex restriction ever proposed in the European Union, significantly impacting the pharmaceutical sector. Due to its complexity, the opinions of ECHA's scientific committees on the pharmaceutical sector are expected to be evaluated sometime in 2025. Regarding the restriction's entry into force, the date is still uncertain and estimated to be sometime between Q4 2027 and Q1 2031.

To date, research has primarily focused on understanding the identity, life cycle, hazard, occurrence, exposure and risk of monomeric PFAS. Polymeric PFAS, on the other hand, is claimed not to be harmful, and there are ongoing discussions on whether polymeric PFAS should be excluded from the proposed PFAS restriction. However, one should consider that monomeric PFAS can be used to manufacture polymeric ones.

Global and regional regulations have created uncertainty around the use of PFAS materials, raising concerns about their application and impact on the global supply chain.

According to a representative from the European Federation of Pharmaceutical Industries and Associations,

“Strategic planning and alternative approaches to avoid disruptions in patient care is needed.”

Louise Loughran, Eli Lilly and Company

That can only be achieved with derogations until suitable alternative solutions are commonly agreed upon and qualified, with the development of partnerships throughout supply chains to manage emissions better, as well as expedite approvals of suitable fluorine-free alternatives from global health authorities.