European Commission considers regulation for ‘bedside’ manufacturing

The EC has published its pharmaceutical strategy to increase access to innovative and safe medicine, including steps to adapt regulation to advanced therapies.

Ben Hargreaves

December 1, 2020

3 Min Read
European Commission considers regulation for ‘bedside’ manufacturing
Image: iStock/olrat

The European Commission has published its pharmaceutical strategy to increase access to innovative and safe medicine, including steps to adapt regulation to advanced therapies.

The ‘Pharmaceutical Strategy for Europe’ was announced last week by the European Commission (EC) in order to strengthen and protect the European Union’s pharmaceutical supply chain, in light of medical innovation and the on-going pandemic. Within the subsection entitled ‘Enabling innovation and digital transformation’, the first example of innovation given is advanced therapies.

In particular, the EC states that cell and gene therapies require a regulatory response, noting the volume of such treatments in development. Last year, the US Food and Drug Administration suggested that 10 to 20 cell and gene therapies could see approval per year by 2025.


Image: iStock/olrat

The paper suggests two ways in which these types of therapies will require adaptation, the method of manufacture and a ‘new business model’ to address their cost, with the latter point being raised by treatments that can offer one-time cures as opposed to chronic treatment.

In relation to manufacture, the EC suggests that there is a shift from therapeutic products being produced in a traditional factory setting towards a ‘bedside’ manufacturing process.

The strategy notes that these new treatment modalities are able to improve patient outcomes and also speed up production time; however, it also outlines that bedside manufacturing can “create new challenges in terms of appropriate quality, inspection and oversight.”

When asked what would be EC’s response to such challenges, a Commission official told Bioprocess Insider that “the strategy will partly analyse the appropriateness of the current regulatory framework, with the purpose to enable those technologies, but also with the purpose to ensure that patients can trust in the quality of the medicine administered.”

The official noted that advanced therapeutics and their manufacture would not be the only spaces where adaption of regulation would need to take place, with nanotechnology, 3D printing, and decentralised in-situ manufacturing also being reviewed.

This conversation around advanced therapies is not happening in a vacuum, with the WHO creating a white paper to increase regulatory alignment across high-income countries, with the aim of establishing a harmonized approach that could then be adopted by low- and middle-income countries to improve access.

Vaccine development

Despite the on-going public health repercussions of the current pandemic, the strategy acknowledges it has brought with it some successes, in terms of the rapid development of vaccines.

The strategy points to the fact that Europe will receive ‘widespread and equitable’ access to vaccines for COVID-19, made available in record time, as an ‘inspiration’ for the future operation of the industry.

In a section on addressing unmet need across public health, however, the EC notes that the lack of development occurring in the vaccines sector to address emerging health threats.

The Commission official stated that the strategy will consider the lesson from the COVID-19 pandemic to determine a way to encourage increased development in the area.

Further than this, the strategy itself notes that the EC will look to support the development of ‘crosscutting technological solutions’, such as vaccine platform technologies, to ‘sustain preparedness’ for future public health threats and countermeasures including research, clinical trials and data infrastructure.

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