EU competitiveness Archives - European Industrial Pharmacists Group (EIPG)

EMA’s pilot scheme for academic and non-profit development of ATMPs

by Giuliana Miglierini Advanced therapy medicinal products (ATMPs) are often developed by academic and non-profit organisations, because of their high level expertise in the biotechnological techniques that underpin many new therapeutic approaches. On the other hand, these organisations often lack Read more

Lessons learnt to transition from Horizon 2020 to the new FP10

by Giuliana Miglierini The European Commission published the ex post evaluation of Horizon 2020 (H2020), the FP8 framework programme for research and innovation (R&I) run in years 2014-2020. The report identifies several areas of possible improvement, which may be taken into Read more

Approvals and flops in drug development in 2023

by Giuliana Miglierini Approvals and flops in drug development in 2023 The European Medicines Agency published its annual highlights, showing 77 medicines were recommended for marketing authorisation, and just 3 received a negative opinion (withdrawals were 19). In 2023 some highly expected Read more

European Council’s recommendations on R&I

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by Giuliana Miglierini

The end of 2023 saw some steps forward to better support the European framework on Research and Innovation (R&I). The Council of Europe approved on 8 December 2023 its conclusions on the impact of research and innovation (R&I) in policymaking. The Council also reached a political agreement on a recommendation of a framework supporting researchers and research careers in the EU. R&I is strategically important as one of the main tools to make Europe more attractive to young talents and to create a open and sustainable European labour market for researchers, innovators and entrepreneurs. We summarise the main features of the Council’s decisions.

How to support the European R&I

The Council conclusions were proposed by the Spanish Presidency (Ministry of Science, Innovation and Universities), and they represent one of its main priorities in the area of research and innovation.

Three mutually complementary dimensions have been identified as fundamental to the success of European R&I. Science plays an important role to reinforce the political process of decision making, which in turn is key to improve life conditions of EU citizens and strengthen democracy. To this instance, the inclusion of scientific evidence and knowledge in the regulatory process and a better coherence of policy initiatives in different areas are deemed important by the Council. According to the conclusions, such an inclusion should help to improve the response capacity of the EU and member states against both structural and cyclical or circumstantial challenges. The document also recalls the ‘Science for Policy’ concept and the EU’s long-standing tradition of relying on science and evidence-based knowledge in all disciplines to support decision-making.

The availability of strong R&I ecosystems in all member states is deemed fundamental to sustain EU’s competitiveness and should be supported among others by the implementation of open-science policies and new technologies and innovation, including social innovation.

The best available scientific evidence should also always be included in impact assessments, so to improve citizens’ trust in public action, as well as the added value of the legislation. To this instance, a rigorous methodological framework would be needed, even though uncertainties are still possible. Transparent and responsible communication would support a better dissemination of scientific outcomes at all levels. The Council also recommended the mapping of the existing practices of knowledge valorisation in policymaking and the national institutional scientific advisory systems and mechanisms. The Commission should also extend the use of the Technical Support Instrument and the Policy Support Facility to support public policymakers and strengthen public structures for scientific advice.

Local and regional innovation ecosystems and ERA’s R&I

R&I may also represent a boost to enhance cooperation and territorial cohesion, reduce R&I fragmentation and disparities between and within member states and to sustain the creation of regional and local innovation ecosystems. Their design should aim to build synergies between cohesion policy and R&I funds. To this regard, according to the Council the R&I framework programme (i.e. Horizon Europe) should continue to drive research excellence in all member states.

Regional centres of excellence may represent a particularly interesting tool to support the regional dimension, with a special attention to the less innovative ecosystems. This goal is part of the New European Innovation Agenda (NEIA), as well as the Regional Innovation Valleys and the pilot project of the Partnerships for Regional Innovation. Cross-border cooperation (especially between less and more innovative member states and regions) may also be key to support better economic, social, and territorial cohesion and reinforce R&I efficiency.

The third dimension is referred to the policy impact of the Recovery and Resilience Facility (RRF) on the design of R&I policies in the European Research Area (ERA) after the pandemic crisis. This last occurrence had a positive effect in enabling many actions at the national level, allowing for targeted investments and reforms. The new ERA should be based on trust, shared responsibilities, and societal engagement and diversity.

Many sectoral and R&I policies experienced a joint approach to their improvement, including the additionality of the Facility with other EU funds. The Council invited the Commission to run a separate study that complements the mid-term evaluation of the RRF, expected by February 2024. The exercise should consider the differences between the RRF and other EU funds.

The reform of research careers

The political agreement reached by the Council on the proposal of a European framework to attract and retain research, innovation and entrepreneurial talents in Europe updates the R1- R4 profiles for researchers, introduced in 2011. It also introduces the European Charter for Re-searchers (ECR), a revision of the 2005 ECR and the Code of Conduct for the Recruitment of Researchers.

The revised definition of researcher and the related research activities are expected to widen career options, thus making European R&I framework more attractive for both internal and foreign talents.

According to the proposal, the term “researcher” would identify professionals engaged in the conception or creation of new knowledge, active in basic or applied research, experimental development, operating research equipment, or project management within any sector of the economy or society (i.e.academia, business, governmental laboratories and the public administration, and the non-profit sector). Careers in research management are also included in the definition.

Four different profiles have been identified to describe the career steps of researchers. First Stage Researcher (R1) are doing research under supervision up to the point of a PhD or equivalent level of competence and experience. Recognised Researcher (R2) hold a PhD or equivalent level of competence and experience but are not yet fully independent in their ability to develop their own research, attract funding, or lead a research group. R1 and R2 refer to researchers at the beginning of their career in science. R3 and R4 refer to senior researchers. Established Re-searcher (R3) holds a PhD or equivalent level of competence and possesses sufficient experience to independently develop and run their own research. Leading Researcher (R4) are recognised as leading their research field by their peers.

The Council recommends that these profiles are referenced to by members states in all vacancies specifically addressed to researchers. Member states are also called to promote equal esteem and reward of the different paths of research careers, regardless of the sector of employment or activity. Appropriate measuring should support comparison of careers across member states, sectors, and institutions, so enabling their full interoperability. The Council recommendation also aims to reduce the precarity of research labour by promoting adequate social protection measures. Inter-sectoral mobility is also encouraged, as well as better equality in research careers, as a tool to respond to the request of highly skilled talents. The Council expects that all organisations employing or providing funding for researchers would provide endorsement of the new “European Charter for Researchers”.

EP’s draft position on Unitary SPC and SPC Regulation revision

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by Giuliana Miglierini

The Committee for Legal Affairs (JURI) of the European Parliament released the draft amendments to the Commission’s proposals aimed to establish a Unitary Supplementary Protection Certificate (SPC) (links to the document and to the procedure) and to revise the current SPC Regulation (links to the document and the procedure).

On the dedicated pages of EP’s website, you can also find the opinion issued by the Consultative Working Party, according to the Inter-institutional agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts.

A document analysing the potential impact of the Unitary SPC on access to health technologies was also prepared by the Policy Department for Citizens’ Rights and Constitutional Affairs Directorate-General for Internal Policies in September 2023.

We summarise the main features of the EP’s draft positions, which were discussed in the 7 November meeting of the JURI Committee.

The revision of the current SPC Regulation

The JURI Committee (Rapporteur Tiemo Wölken) moved to Recital 2 the statement that “medicinal products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research”. Recitals 3 and 5 of the original proposal have been deleted, the last one referring to the risk research centres located within the EU might move to countries offering greater protection. The new Recital 2 makes now reference to the difficulty of establishing a direct link between favourable protection rules and EU competitiveness. If, on the one hand, it would be true that the attractiveness of EU markets might benefit from favourable protection, on the other it should be taken into account that European incentives can be granted also to authorised medicines from third countries. Furthermore, UE-based innovative companies can equally benefit from incentives in third countries.

Recital 13, referring to the request of a marketing authorisation for a biological medicinal pro-duct identified by its International Nonproprietary Name (INN), has been amended to indicate that the protection conferred by the SPC should extend to all biosimilars (and not to therapeutically equivalent products, as previously indicated).

A reference to Article [86] of the new Directive (EU) …/… [2023/0132(COD)] to be approved has been introduced in Recital 24, concerning fees that can be charged by the European Union Intellectual Property Office (EUIPO) with reference to centralised application for SPCs for paediatric medicinal products.

The newly inserted Recital 41 a highlights the importance of the timely entry of generics and biosimilars in the EU market, as it may support competition, reduction of prices, sustainability of national healthcare systems and access to affordable medicines.

Several amendments have been proposed for Recital 45. Among the main ones is the reference to the opportunity “to restrict the protection conferred by a supplementary protection certificate in accordance with Regulation (EU) 2019/933 so as to allow making for the exclusive purpose of export to third countries and any related acts in the Union strictly necessary for making or for the actual export itself […]”. The JURI Committee referred to “related acts” as those that “could include the possession, supply, offering to supply, import, using or synthesis of an active ingredient for the purpose of making a medicinal product containing that product, or temporary storage of the product or advertising for the exclusive purpose of export to third-country destinations”.

A phrase was added to Recital 60 on the centralised SPC register to deny the possibility to use the hereby contained information to support patent linkage, regulatory or administrative decisions related to generic or biosimilars, pricing and reimbursement decisions or tender bids. Article 35 – paragraph 11 a further emphasises this concept with reference to public authorities, that should not use such information for refusal, suspension, delay, withdrawal or revocation of marketing authorisations.

The JURI Committee also modified the definition of medicinal product contained in Article 2 – paragraph 1 – point 1 of the proposed Regulation, making reference to “‘any substance or com-bination of substances that fulfils at least one of the following conditions”. These include properties for treating or preventing disease in humans, the possibility to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

The new Article 2 – paragraph 1 – point 12 a defines the meaning of the wording ‘economically linked’ with reference to “different holders of two or more basic patents protecting the same product, that one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder”.

The JURI Committee also introduced the new Article 8 – paragraph 1 – point d b, stating the need to provide information on any direct public financial support received for research related to the development of the product.

The new Article 26 – paragraph 4 – point c a mentions the inclusion of any evidence in the notice of opposition in support of the opposition itself. According to the amended Article 26 – paragraph 6, the opposition panel should communicate its decision together with the reasoning for it. The same applies to the EUIPO (Article 26 – paragraph 9). The Office should also issue a single decision with reference to several oppositions filed against an examination opinion (Article 26 – paragraph 9 a). Undue delays are repeatedly discouraged.

Article 28 – paragraph 3 – point a was amended to indicate that examiners of patents and SPCs should possess relevant expertise and sufficient experience in the assigned tasks. Article 45 – paragraph 3 adds experts shall be verified for the absence of any conflict of interest.

Amendments of the Unitary SPC proposal

Many of the amendments made by the JURI Committee to the Unitary SPC proposal correspond to the ones seen above for the SPC recast. Among the distinctive ones is the new Recital 14 a, focusing on the “digital by default” principle and consequent electronic applications for unitary and combined applications for supplementary protection certificates. Article 8 – paragraph 4 a adds that the electronic application for a unitary SPC should use the formats made available by EUIPO. Other articles regulate the entire procedure to occur by exchange of electronic documentation.

Amended Recital 22 now makes explicit reference to the possibility to produce and store in the EU “in view of entering the market of any Member State upon expiry of the corresponding certificate (‘EU Day-one entry’) and any acts related thereto”.

The new Article 22 – paragraph 1 – point c b defines cases where the applicant shall waive the SPC rights for markets where the medicinal product has not been launched, i.e., the medicinal product is not placed on all Member States or a Member State market covered by the unitary certificate or combined centralised SPCs.

Comments from Medicines for Europe

The first drafts of the EP position on the SPC and SPC Regulation recast are a step in the right direction for access to medicines across Europe, according to Medicines for Europe. The association particularly appreciated the identification of the necessary safeguards for scrutiny of the SPC application before granting, to prevent invalid (non-innovative) SPCs from delaying access to generic and biosimilar medicines. The undue use of SPC expiry dates in the register to implement unlawful and anti-competitive patent linkage strategies were also deemed positive.