Manufacturing and supply chains of critical chemicals, including raw materials, intermediates and active ingredients of pharmaceuticals, have become increasingly complex and globalized. The Chemical Strategy for Sustainability (COM (2020) 667 final), published in October 2020, stated that a more resilient economy and healthcare system requires sufficiently diversified sources of supply and a better management of risks of disruption, as well as mechanisms to ensure that supply chains continue to operate during crises, such as the COVID-19 pandemic. In addition, the Commission stated in the Chemicals Strategy, that it will address the impact on the environment of the production and use of pharmaceuticals in the upcoming pharmaceutical strategy for Europe.
How does the Pharmaceutical Strategy respond to the calls for change?
The key objectives of the Pharmaceutical Strategy for Europe (COM (2020) 761 final), published in November 2020, are to ensure access to medicines, support competitiveness and innovative capacity of pharmaceutical industry, develop open strategic autonomy, and address antimicrobial resistance (AMR) and environmental risks. The Commission states again, that there is greater awareness of the need to ensure that our use of pharmaceuticals is sustainable, and that well-functioning international supply chains are needed.
Indeed, the Pharmaceutical Strategy includes a proposal for reviewing pharmaceutical legislation for human use (directive 2001/83/EC; regulation 726/2004/EC) to introduce measures to restrict and optimise the use of antimicrobial medicines. Regarding environmental risks, the Pharmaceutical Strategy refers to European Green Deal (COM (2019) 640) zero-pollution ambition and the Chemicals Strategy, as well as the Circular Economy Action Plan (COM (2020) 98 final), stating that they establish a framework for generating an overall shift to a production and consumption of resources and pharmaceutical raw materials which are safe, and create the lowest possible impact on the environment and the climate. Concrete proposals in the Pharmaceutical Strategy include a revision of the pharmaceutical legislation to strengthen the environmental risk assessment requirements and conditions of use for medicines, as well as continuing the implementation of the actions under the Strategic Approach to Pharmaceuticals in the Environment (COM (2019) 128). The Commission underlines that innovation for environmentally sustainable and climate-neutral pharmaceuticals and manufacturing should become a driver for the EU pharmaceuticals industry.
However, when it comes to strategic autonomy, the proposed actions are quite modest. The Commission announced that they have launched a study to map the root causes of shortages of medicines. The Commission states that reasons for shortages are complex, including marketing strategies, scarce active pharmaceutical ingredients and raw materials, weak public service obligations, or issues linked to pricing and reimbursement. The ongoing study will inform the evaluation and revision of the current legislation, and possible legislative measures may include stronger obligations on the industry to ensure stable supply. This is not a very strong signal about moving pharmaceutical production back to Europe, and it has been criticized.
Structured dialogue and European Health Emergency Response Authority (HERA) as concrete measures to enhance health crisis response mechanisms
The Commission admitted that the COVID-19 pandemic has shown that public authorities do not often have access to complete information about the structure of manufacturing and supply chains of pharmaceuticals.
The proposed actions to address this challenge include a structured dialogue with the actors in the pharmaceuticals manufacturing value chain, public authorities, patient and health non-governmental organisations and the academics. The Commission suggests that in the first phase the aim is to gain a better understanding of the functioning of global supply chains and identify the causes and drivers of potential vulnerabilities. In the second phase, the dialogue will serve to put forward a set of possible measures and formulate policy options to ensure the security of supply and availability of critical medicines, active pharmaceutical ingredients and raw materials.
The HERA will strengthen the coordination of operations across the whole value chain. It will anticipate specific threats and monitor for example production capacity, raw material requirements and availability, thus addressing supply chain vulnerabilities. This will require the assembly of ecosystems of public and private capacities. The Commission aims to propose the new authority in 2021.
Collaboration breaks down silos
The Commission accentuates that a comprehensive, integrated approach is needed to ensure that the Pharmaceutical Strategy is successful. Working together across disciplines and regulatory competences throughout the lifecycle of medicines and making the most of collaborative civil society dialogue will be the key for the transition. I could not agree more, but we need also more public pressure to stress the importance of stable, sustainable and transparent supply chains of pharmaceuticals.