The European Commission released in April 2024 its proposals for the European biotechnology and biomanufacturing sectors. Actions are based on the identified barriers and challenges still to be solved, among which are these are research and technology transfer, regulatory complexity, access to finance, skills, value chain obstacles, intellectual property, public acceptance and economic security. Among the more significant measures impacting health biotechs, the Commission should launch a study to investigate the EU’s position compared to other global leaders in emerging biotechnology generation and transfer to the biomanufacturing industry. The Industrial Biotechnology Innovation and Synthetic Biology Accelerator (EU IBISBA) should be established as s a trusted digital repository and service network for the sector. Streamlining regulatory pathways is another key objective of the proposal, aimed to reduce fragmentation, explore potential simplification, and shorten the time to market. The Commission will also support structured exchanges with stakeholders to accelerate the uptake of AI, and in particular Generative AI.
Giuliana Miglierini
EFPIA, position paper on drug repurposing
So-called drug repurposing has taken hold in recent years as a development process aimed at giving new life for new indications to drugs that have been on the market for some time and are often off-patent. On the occasion of the first conference on drug repurposing, held at the beginning of March in Barcelona, EFPIA published a position paper highlighting some important elements, from an innovator industry perspective, to optimise drug repurposing activities.
Repurposing activities should be increasingly supported in the future by the ability of new artificial intelligences to select the most promising molecules within very large sets of possible candidates. However, there is currently no unambiguous definition of the term repurposing. From this point of view, the position paper indicates that repurposing generally refers to molecules without patent and regulatory data protection, for which regulatory-grade evidence supporting a potential new use is made available, also by non-profit third parties such as universities. EFPIA emphasises that this definition excludes from the scope of repurposing activities typical of innovator companies, such as new uses of products in development (such as new dosage forms or formulations) or drugs that have recently been approved and for which the originator company is still carrying out some activities, as well as abandoned compounds.
The JURI Committee position on Union compulsory licensing
The Committee for Legal Affairs (JURI) of the European Parliament approved on 19 February its position on the EU Commission proposal of a regulation governing Union compulsory licensing. The process would be activated in cases of health crisis or emergencies. According to the rapporteur, a main concern refers to the maintenance of the right equilibrium and motivation for innovation and rapid access to essential products and technologies during crises.
Union compulsory licenses should be granted following a 4 weeks period during which the rights-holder may look to find a voluntary licensee. The Parliament asked for a better definition of the term ‘crisis’, as well as the know-how, and how the know-how necessary for the manufacturing of certain products would be disclosed under the Union compulsory license framework. The role and composition of the advisory body should be also clarified, and better guidance on calculation of remuneration for rights-holders should be provided.
Source: European Parliament
The EU Commission proposal for the revision of the Variations Regulation
The Commission published its proposal for the revision of the Variation regulation for medicines, as a part of the EU’s Pharmaceutical Strategy for Europe. The final objective is to adapt the current system for variations to the evolving reference framework, to make it more efficient, reduce administrative burdens and better respond to scientific and technological advances.
MAHs are responsible for ensuring that each medicine remains compliant throughout its lifecycle. Variations to the initial authorisation can refer to administrative details, such as a change in company address, or to substantial changes, such as changes to the patient and healthcare information, the active substance or strength of the medicine.
The Commission’s proposals simplify the notification of minor, type IA variations, and introduce among others the possibility of super-grouping certain types of variations.
Source: European Commission
Unitary SPC, the EU Parliament approved its position
The European Parliament adopted on 28 February 2024 in first reading its position about Unitary supplementary certificates (SPCs) for medicinal products and pesticides. The final phase of negotiations with the European Council, representing member states, should occur after the June elections, according to the Parliament. The Unitary SPC should add 5 years to the protection conferred by the original patent, complementing the Unitary patent system.
Protection would cover all countries part of the European patent system. Applications for the unitary SPCs should be submitted at the European Union Intellectual Property Office (EUIPO), to be examined by one EUIPO member and two examiners from national patent offices with sufficient expertise and experience. For medicinal products, the entire procedure should be electronic, and based on the centralised regulatory procedures already in place to obtain the marketing authorisation for innovative medicines.
The industrial requests of a stronger Single Market
EFPIA is among the twenty-six industry associations that have signed a document calling on the European Commission to deepen the EU Single Market. A target deemed fundamental in order to better face competition from countries such as the US and China. According to the document, current actions focused on mapping strategic dependencies, anticipating vulnerabilities, beefing up autonomy, and de-risking should be balanced with the promotion of a frictionless trade within the EU.
The goal should be addressed by the systematic enforcement of Single Market rules and the full harmonisation of the regulatory framework in key areas. Nevertheless, there are still many obstacles to overcome, which have been reported by the industry associations in the updated version of their Compendium on Single Market Obstacles. The fragmented European market is less attractive for companies to invest and scale up rapidly in the EU. The statement calls European institutions to make the development of a simplified, and harmonised regulatory framework across the 27 EU Member States a priority for political action up to 2030.
Source: EFPIA
EU Council approved the conclusions on the EU Global Health Strategy
The fact that physical and mental health is a human right and that health is a prerequisite for sustainable development are among the conclusions on the ‘EU Global Health Strategy: Better health for all in a changing world’ approved on 29 January 2024 by the European Council. The document reaffirms the leading role of the EU and member states in advancing global health: an effort that would require multilateralism and inclusive multistakeholder partnerships.
The Council identified three complementary priorities of the EU Global Health Strategy: deliver better health and well-being for people across their life course; strengthen health systems and advance universal health coverage; prevent and combat health threats, including pandemics, applying a One Health approach. The EU Commission, the High Representative and member States are now called to apply these guiding principles and to implement the resulting lines of action and initiatives, among which is the multilateral cooperation with the World Health Organization (WHO).
Concerns on the Munich District Court decisions on SPC
The first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany in October 2023 caused a deep concern among the generic and biosimilar industry, as highlighted in a note from Medicines for Europe. According to the industrial representative, the Munich District Court would have adopted an inordinately restrictive interpretation of the SPC manufacturing waiver, which contradicts the purpose and spirit behind the amendments introduced until its final approval. “This utterly frustrates the aims of the legislation and disincentivises investments in Europe”, writes Medicines for Europe.
More in particular, the industrial association disagrees with the judgment that SPC manufacturing waiver for export would require notification of a marketing authorisation (MA) number – even if no MA number is publicly available – or the disclosure of confidential information about future country of submission. According to the Court, these requirements would derive from an alleged need to ensure that there are no intellectual property rights in the foreign country of export. The German first-instance judgment further suggests that for manufacturing in the EU and export to a third country to be permissible, a granted MA in such third country would be required.
Medicines for Europe concerns extend to the possibility the outcomes of the judgment could be used by SPC holders to threatener sue existing and future users of the SPC manufacturing waiver. The ongoing reform of the SPC regulation may also add some other confusion, according to the note. Medicines for Europe thus asks for a urgent clarification and simplification of the SPC manufacturing waiver legislation, to make the EU an attractive place for developers and manufacturers of pharmaceutical products, and to strengthen the security of supply.
The creation of the African Medicines Agency
A €10 million grant from the European Commission will allow the European Medicines Agency to provide support to the establishment of the African Medicines Agency (AMA), in collaboration with African, European and international actors. The agreement signed between the EU Commission’s Directorate-General for International Partnerships and EMA marked the official launch of the project. AMA will act as the specialised agency of the African Union (AU) for the regulation and oversight of key medicinal products in Africa.
The treaty establishing AMA has already been signed by 27 African countries, and some other are expected to complete the process in the coming months. EMA’s role in supporting the creation of the African Medicines Agency would also benefit from the long-standing experience of the national regulatory authorities that are part of the European medicines regulatory network (EMRN). More in particular, the EMRN will share experience with AMA in pooling resources and coordinating work to regulate medicines efficiently and effectively, ensuring high-quality standards and use of the best available expertise, while reducing administrative burden.
EMA-HMA and MHRA plans on artificial intelligence
The role of artificial intelligence (AI) is rapidly expanding in the regulatory field, as acknowledged by the new plans published by EMA and the Heads of Medicines Agencies (HMAs) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the EU, the AI workplan to 2028 prepared under the joint HMA-EMA Big Data Steering Group will support the European medicines regulatory network (EMRN) in the use of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making.
At the level of guidance, the public consultation on EMA’s AI reflection paper, closed at the end of December 2023, and it should be followed in 2024 by preparations to support the implementation of the EU AI Act. The plan also aims to identify and provide a framework across the network for the use of AI tools. Training shall be also provided, and the fundamental role of experimentation in accelerating learning and gaining new insights should be valued. In the UK, MHRA’s regulatory roadmap for new regulations aims to support the safe access to transformative medical technologies, such as new implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease. The new Statutory Instruments (SIs), which are part of the roadmap, are expected to support the delivery of effective regulation and greater international harmonisation.
Source: EMA, MHRA
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