Business & Policies Archives - European Industrial Pharmacists Group (EIPG)

Trends in Drug delivery and Formulation


by Giuliana Miglierini According to the 2021 Global Drug Delivery & Formulation Report, signed by Kurt Sedo, Vice President Operations, PharmaCircle LLC and published in a three-part series on Drug Development & Delivery, the Covid-19 pandemic seems to have had Read more

The new European Innovation Agenda


by Giuliana Miglierini A new piece of legislation adds to the framework supporting the new paradigms set forth by the European Commission: the European Innovation Agenda (EIA) aims to position the EU as a global leading player in innovation, especially Read more

ICMRA, two pilot programmes to optimise regulatory assessment and inspections


by Giuliana Miglierini New flexible modalities for the management of regulatory procedures are becoming progressively accepted even for routine activities, upon the experience built during the pandemic. Efforts are ongoing at the global level in order to better harmonise the Read more

The new European Innovation Agenda

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by Giuliana Miglierini

A new piece of legislation adds to the framework supporting the new paradigms set forth by the European Commission: the European Innovation Agenda (EIA) aims to position the EU as a global leading player in innovation, especially in the field of deep techs. These are usually referred to as a combination of physical, biological and digital emerging technologies targeted to develop new, transformative solutions in all areas of economy and society.

Breakthrough R&D and large capital investment are the identified tools to support their development. “We need to boost our innovation ecosystems to develop human-centered technologies. This new Innovation Agenda builds on the significant work done already on innovation in the last years and will help us accelerate our digital and green transition. The Agenda is rooted in the digital, physical and biological spheres and will enable us tackle better burning concerns, such as breaking the dependence from fossil fuels or securing our food supply in a sustainable way.”, said Margrethe Vestager, Executive Vice-President for a Europe fit for the Digital Age.

The five areas of intervention

The European Innovation Agenda is divided in five different flagship areas, for a total of 25 actions.

Startups and scale-up companies will be the central focus of the Agenda and the target of investments by both private capital and institutional investors. Simplified listing rules are planned to support their scaling. The debt-equity bias reduction allowance on corporate income tax would also benefit of a later stage venture capital financing, with expansion of the European scale-up action for the risk capital mechanism under InvestEU. An innovation gender and diversity index and the EIT Women2Invest Programme are other planned actions in the area.

Relevant investments are envisaged to attract and train at least 1 million talents in the field of deep tech and to support women entrepreneurship. Among the planned activities are an innovation intern scheme for startups and scale-ups, and an EU talent pool to help young innovative companies to attract extra-EU specialists. A Women entrepreneurship and leadership scheme and the establishment of a best practice exchange on startup employees’ stock options are also planned. Other initiatives shall support the promotion of an entrepreneurial and innovation culture; these actions will include support to education and innovation practice communities, Erasmus+ alliances for innovation, and a Digital Europe call to train future experts.

Under the regulatory perspective, regulatory sandboxes and experimentation spaces coupled to public procurement are expected to facilitate the development of new ideas. Among the possible experimental approaches mentioned by the EIA there are open innovation test beds in renewable hydrogen, living labs and innovation procurement. This last sector may see the establishment of an Innovation Procurement Specialist Advisory Service.

Guidance will be provided to policy makers on regulatory sandboxes. State aid rules shall also be revised to better support the construction of testing and experimentation facilities, namely in the field of AI innovation.

Interconnections of the different players and the creation of a network of European Innovation Ecosystems will be pursued through “regional innovation valleys”. Interregional innovation projects should benefit of a total budget of €10 billion, that shall also be used to support member states’ efforts towards the integrated use of cohesion policy and Horizon Europe instruments. Among the planned actions is the doubling of the number of Hydrogen valleys in the EU, the creation of a Innospace (a one stop shop for innovation) and the establishment of the EIC ScaleUp 100 index, reflecting the hundred deep tech startups with the potential to scale up as global leaders or potential unicorn.

Finally, the transparency of the overall process will be pursued using clearer terminology, indicators and data sets to improve the policy framework, and a better policy support to member states. This shall allow for a better comparability of data sets and the use of shared definitions to inform and coordinate policies at all levels, through the European Innovation Council Forum.

The new European Innovation Agenda will complement existing tools to support R&D and innovation, such as Horizon Europe’s actions targeted to startups, scaleups and small and medium-sized enterprises (SMEs), the funding by the European Innovation Council (EIC) (we wrote about this here) and the new Knowledge and Innovation Communities (KICs) created by the European Institute of Innovation and Technology (EIT).

Comments from the stakeholders

For more than a year we have consulted the stakeholders, such as innovation ecosystem leaders, startups, unicorns, women founders, women working in the capital venture, universities, and businesses. Together, we will make Europe the global powerhouse for deep-tech innovations and startups”, said Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth.

Among contributors to the debate was EuropaBio, that published its response to the Commission’s proposal.

The requests of the association representing the biotechnology industry to remove regulatory barriers through the establishment of regulatory sandboxes has been recognised in the EIA, as well as the need to invest in scientific and industrial excellence and bridge the innovation gap between member states. Other key issues highlighted by EuropaBio included the need to review the GMO legislation to overcome the process-based approach that often results in unequal regulatory treatment for similar products with equivalent risk profiles, together with improved policies for rewarding innovation and the need to build digital literacy skills.

The Irish Pharmaceutical Healthcare Association also commented the Commission’s proposal. According to the post signed by Bernard Mallee, IPHA’s Director of Communications and Advocacy, despite the effort of the Commission to boost innovation and fill the gap with US and China in the development of breakthrough treatments, mixed results may be expected. Incentives in areas of unmet medical need and the fight against antimicrobial resistance are identified as key issues. The suggested solution is a better underlying commercial model targeted to invest in the development of new antibiotics, and the importance of health data in driving medical research and managing healthcare systems. Improved iterative scientific dialogue and dynamic regulatory assessment based on real-world data and innovative trial designs are other point of concern for IPHA. Harmonisation of the EU Special Protection Certificate framework was also suggested, while the coordination of compulsory licensing in emergency situations in Europe was judged at risk of de-incentivise innovation. IPHA also supports the High-Level Forum on Better Access to Health Innovation initiative launched by EFPIA.

Positive comments to the new European Innovation Agenda also came from the European Startup Network (representative of 38 national startups associations) and the European Regions Research and Innovation Network (ERRIN) (see more on ScienceBusiness).

The revision of the pharmaceutical legislation is also central to the agenda of the Czech EU Presidency for the second half of 2022. Again, the goal is to close the gap with the competitor countries and speed up the approval of new treatments. According to Euractiv, it takes on average 150 days longer to get an innovative medicine approved in Europe than in the US. Just 22% of innovative medicines are being developed in the EU, vs 48% of the US (data EFPIA).


EIC: challenges for the governance and opportunities for innovation

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by Giuliana Miglierini

The European Innovation Council (EIC) was launched in March 2021 by the EU Commission to support the growth of highly innovative startup companies. Since then, the programme experienced some difficulties to become fully operative, as delays occurred with companies requesting grant-only or grant-first support and with the decision-making procedures for companies requesting blended finance or equity-only investments.

According to the Commission, this situation is a result of the restructuring of the EIC Fund to better reflect Horizon Europe legislation and the outcomes of the pilot phase. Negotiations are also ongoing with an external fund manager of the EIC Fund and are expected to close by the end of June. Internal discussions in the European Commission and IT problems are among the possible causes of the delays, reported Politico. A situation that is highly impacting on the selected companies, that are hampered from proceeding with the timely development of their business.

The difficult governance of the EIC prompted the European Parliament to start an investigation, led by Horizon Europe’s rapporteur Christian Ehler, to better clarify the issues undermining the EIC functioning (see more on ScienceBusiness). Mr. Ehler asked the stakeholders to provide inputs by 14 June; the final outcomes of the investigation will be summarised in a non-legislative report on the implementation of the EIC.

The idea behind the report is to get the debate about the future of the EIC out in the open and provide the Parliament’s perspective on it. As co-legislator we have a duty to ensure the Commission implements the legislation we approved,” said Christian Ehler.

The EIC Accelerator

Available investments for startups and SMEs under the EIC Accelerator programme total €2.5 million for grants and €0.5 to €15 million equity investments through the EIC Fund. Higher investments are possible to support the development of technologies of strategic European interest.

A fast assessment procedure was introduced in 2021 to submit new projects at any time. A tailored business coaching support is available to successful candidates to draft the full applications, which are then evaluated at regular cut-off dates approximately every three months. The Commission announced it is finalising its decision-making procedure for the grant and equity components to companies selected for blended finance during the 2021 cut-offs. This is expected to allow the signature of contracts for the grant component of blended finance in a couple of days after the closure of the decision-making procedure, followed by the payment of a pre-financing of the grant one week later. A due diligence is needed to support the investment decision by the EIC Fund for the equity component, that will thus occur few weeks or months later.

The current status of the EIC Accelerator

According to the European Commission, 65 companies were selected for funding under the EIC Accelerator programme for the June 2021 cut-off, following the evaluation of their full application. Of these, 29 companies requested grant-only or grant-first support and 31 requested blended finance, including a grant component and equity investment. Contracts for six grant-only or grant-first companies were still to be signed as of 13 May 2022. The grant component is expected to close by early June 2022, while for the equity investment component and equity-only closure of the investment agreement is expected after June.

Some other 99 companies were selected for support in the October 2021 cut-off. Only one contract of the overall 34 companies that requested grant-only or grant-first support has been signed. Signature of the grant component for companies that selected blended finance is planned in July 2022, followed by the equity component and equity-only projects from the summer up to the end of the year.

The third cut-off round of March 2022 saw the selection of some other 74 companies, over a total of more than 1000 applications. Selected companies will each receive grants and/or equity investments up to €17.5 million. The next cut-offs for full applications is 15 June and 7 October.

Deep-tech training needed

A report published in April 2022 by the EIC Pilot Expert Group suggests the creation of two new deep-tech training programmes to better support the development of human entrepreneurial talent while fostering technological solutions. “We argue that EIC can’t succeed without including in its mandate the objective of proactively realising the entrepreneurial talent of Europe’s brilliant scientists”, write the members of the Expert Group in the foreword of the document.

The EIC Trailblazer Programme and the Pioneer Programme are the tools identified to reach this challenging goal. Both of the programmes should be implemented in a phased manner using pilot projects to allow for experimentation and learning, according to the recommendations set forth in the report. A main expected outcome is the creation of a new generation of deep-tech entrepreneurs, the EIC Innovators, able to better evaluate how their technologies are fitting into the world for commercialisation and impact.

The EIC Trailblazer Programme is targeted to support talented PhD candidates and postdocs that are part of projects funded by the EIC Pathfinder and EIC Transition. These EIC Trailblazer Fellows may receive a deep tech training programme, aimed to work as an internal accelerator and an elite programme targeting proto-entrepreneurs. A special prize and/or grant may also be considered to recognise scientific and entrepreneurial talents.

The Pioneer programme would allow for deep-tech add-on modules sponsored by the EIC to complement existing programmes delivered at the local level, in member states and potentially EU associated countries. Beneficiaries would include talented scientists that one day may apply for EIC funding, the “proto-EIC Innovators”.

Comments from research-intensive universities

The Guild of European research-intensive universities published a statement to contribute to MEP Christian Ehler’s initiative of a report on the implementation of the EIC. A better recognition of the role of universities’ Technology transfer offices (TTOs) as key actors in enabling researchers to develop their results for commercial and societal purposes is the key message of the Guild. To this instance, duplication of activities of the TTOs in terms of project management and support services should be avoided. Concerns are also highlighted with reference to the standard Intellectual Property (IP) provisions in the EIC Pathfinder and Transition schemes, as they might negatively affect the functioning of already well-performing TTOs without strengthening the capacities of weaker TTOs.

A positive experience is also acknowledged as for the EIC Transition scheme, that supports universities and their spin-offs with appropriate financial support for proof-of-concept projects. The Guild asks for the extension of this funding scheme to support an higher number of innovative projects.

An example of funded project

Swedish company Bico (formerly Cellink) is an example of EIC-funded project which saw a very rapid growth of its business, achieving $ 1 billion in market valuation in the first five years of activity. Founded in 2016, the company is now leader in the bioink sector and is developing new bio-printing technologies to be used for 3D printing of organs and tissues, so to overcome the lack of donors, reduce shortages and improve drug development.

Bioprinting is only one of the technologies included in Bico’s portfolio; gene therapy, gene editing, CRISPR, diagnostics are also investigated. The company built up from the first universal bioink created by Professor Paul Gatenholm (Chalmers University), a special biomaterial that enables human cells to grow outside the body and perform all the vital functions.


Draft topics for the first IHI calls for proposals

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by Giuliana Miglierini

The Innovative Health Initiative (IHI) published on its website the first draft topics which may be part of the first two calls for proposals, scheduled in June 2022. Interested parties may start the activities needed to build and formalise the research consortia, taking into consideration that the announced topics are draft, pending their approval by the IHI Governing Board and their final version may differ from the drafts.

IHI call 1 shall focus on innovative technologies for the development of decision-support system for improved care pathways, next generation imaging, personalised oncology and access and integration of heterogeneous health data in areas of high unmet public health need.

IHI call 2 shall address cardiovascular diseases and the development of a harmonised methodology to promote early feasibility studies.

The draft topics of IHI call 1

Innovative decision-support systems are important to make available improved care pathways for patients with neurodegenerative diseases and comorbidities. The actions to be undertaken include the enhanced cross-sectoral and sustainable collaboration between healthcare industries, academia and other stakeholders in order to exchange data (through the new European Health Data Space), analytical tools and material for training and professional development of personnel.

Earlier diagnosis should lead to more clinically effective interventions and reduced hospitalisation and facilitate the adherence to therapy. Clinical outcomes are expected to support a better patient stratification, which is needed to develop more patient-adapted interventions, therapeutics and cost-effective pathways for the management of neurodegenerative diseases. Among the expected outcomes is the development of a re-usable, interoperable, easily adaptable, and scalable digital platform, initially targeted to support patients in this therapeutic area, but further expandable in the future to other areas of interest. The action should also involve the development of agreed standards and guidelines to support data collection and operational features of the digital platform. New algorithms may provide (near) real time feedback on health interventions and support the constant monitoring of the patient’s status.

The second topic is focused on the development of high-quality tools, high-quality data, advanced patient imaging and image-guided technologies and processes for improved early diagnosis, prognosis, staging, intervention planning, therapy and management of cancer. Imaging can be part of new combined cancer therapies (e.g., theranostics, chemotherapy, targeted therapy including immunotherapy, radiotherapy and/or surgery). The call should also include the development of improved validation and evaluation methodologies specific to artificial intelligence (AI)and machine learning (ML), with a particular attention to the creation of new solutions that automatically link images to clinical data. This could be applied, for example, to develop minimally invasive interventions guided by medical imaging, or image-driven planning and predictive tools.

The third topic is also aimed to tackle cancer through the development of personalised interventions. This action should contribute to break down silos that are often still characterizing medicine and technological areas. The availability of harmonised approaches should lead to safe and effective innovative health technologies, to the integration of future products, services and tools and the development of more patient-centred tools. Here again, an expected outcome is represented by a dynamic platform for R&I collaboration across different sectors and stakeholders, focusing on the early stages of applied clinical research on cancer and on the testing and validation of multi-modal therapeutic approaches, including novel or emerging technical and clinical concepts and the possible contribution arising from in vitro diagnostics.

Topic 4 of IHI 1 addresses the integration of future products, services and tools along the healthcare pathway to better respond to specific patients’ needs. The availability of interoperable, quality data which reflect the FAIR principles (Findability, Accessibility, Interoperability, Reusability) is central to this action, as well as the development of advanced analytics/artificial intelligence supporting health R&I. Among the main expected outcomes is the long-term access to diverse types of data enabled by the linkage and integration of novel and cross-sectoral sources. Access to interoperable tools should also become possible for citizens and patients to support the self-management of health and the joint decision making process between healthcare professionals and patients.

The draft topics of IHI call 2

Cardiovascular diseases (CDV) remain one of the main causes of death; the development of new tools for the primary and secondary prevention of CDV is the main focus of Topic 1, to be pursued by the identification of existing comprehensive CVD and heart failure (HF) patient datasets, in order to facilitate the diagnosis of atherosclerosis and HF. These data shall be also integrated with those captured by diagnostic tools (e.g., wearables, imaging devices, bio samples/biopsies).

Classical diagnostic screening, in-vitro- diagnostics, ‘multi-omic’ platforms (e.g. genomic, transcriptomic, proteomic and multimodality imaging data), continuous glucose monitoring (CGM) data, continuous electrocardiogram (ECG) from wearable, HF and activity data, wearable devices and digital health applications are all possible sources for the data. Projects may also leverage data in currently available IMI federated databases in compliance with the GDPR regulation governing protection of personal data.

The utility of already existing or new biomarker combinations shall be assessed to detect patients at risk, also making use of AI models to analyse data. Validated data referred to patient reported outcome and experience measure (PROMs and PREMs) may also be considered for use in the clinical setting.

The second draft topic is targeted to establish a harmonised methodology to promote the diffusion of Early Feasibility Studies (EFS) among healthcare professionals. Once again, the availability of digital technologies easily accessible by patients shall be key to this action. Among expected outcomes are the improvement of the quality of clinical evidence on health technology innovation generated through earlier clinical experience, together with the increase of the attractiveness of clinical research for healthcare technologies in the EU.

These activities are essential to enable the fast translation of innovation into the clinical practice, improving access to patients especially where there are only limited or no alternative therapeutic options. This approach to the development of innovative technologies may also benefit regulators and health technologies assessment (HTA) bodies, as well as notified bodies. All stakeholders involved in clinical practice and research may contribute to the early generation of quality data, so to achieve a better understanding of diseases management and treatment options and to support the future development of new medical guidelines.

The creation of hubs of clinical excellence to attract investment may also be considered under this topic, with involvement of developers of medical devices, drug-device combination products, imaging equipment, in-vitro diagnostics, and SMEs.


IPI, a new international procurement instrument at the EU level

by Giuliana Miglierini

After ten years of debate, a new era in the field of European public procurement is opening: negotiators from the French Presidency of the European Council and the European Parliament reached a provisional agreement on 14 March 2022 on the draft regulation establishing the new International Procurement Instrument (IPI). The tool aims to achieving a true reciprocity in access to international public procurement markets.

Currently, European procurement is broadly open to companies from third countries, but European companies do not always have reciprocal access to public procurement in those countries. This new European instrument will equip the EU with credible leverage to open up our partners’ public procurement to our companies and will enable us to right that imbalance and defend our companies against these discriminatory practices. Today’s well-balanced agreement is a historic step in implementing an open, sustainable and firm trade policy”, commented Franck Riester, French Trade minister.

The agreed draft text is based on the second, amended proposal of a regulation adopted by the EU Commission on 29 January 2016, after the failure of the first version dated 21 March 2012. The mandate to negotiate for the European Council was approved on 2 June 2021. Further steps are now needed before the final adoption of the IPI regulation, including finalisation of the text at the technical level, approval by the EU’s Permanent Representatives Committee, and final vote by the Parliament and Council. Guidelines are also expected from the EU Commission to facilitate the application of the new regulation.

How IPI will work

Public procurement accounts for 15 to 20% of global GDP (data EU Commission). Historically, there is an unbalance in access to public procurement markets, with European companies often experiencing significant barriers to enter third countries.

The mechanism foreseen by the IPI tool requires the Commission to carry out a transparent investigation on bids made by extra-EU companies wanting to participate to public procurement tenders in the EU, should EU companies be subject to serious and recurring barriers to access the third country’s public procurement practices. The concerned country will be invited to participate to the investigative procedure, in the form of consultation. Should it decline the invitation, reciprocal measures will be applied by the EU to restrict the access of the third country’s companies to European public procurement market. More in detail, restrictions of access may take the form of a price penalty (up to 100%, if only price is taken into account), a reduced score (max. 50% score adjustment), or exclusion from the tendering procedures.

Once adopted by the European Council and Parliament, the IPI regulation will only apply to cases for which an international public procurement agreement between the third country and the EU is not in place, or where such agreement does not include commitments to open up markets for the goods or services under consideration. Furthermore, it won’t be possible for the Commission to investigate the practices of least-developed countries which benefit from the “everything but arms” arrangement, a provision intended to encourage the sustainable growth in lowincome countries.

Negotiators also established a limit value for the application of the new procurement procedures, i.e. an estimated value equal to or above €15 million excluding VAT for works and concessions, and ≥ €5 million for goods and services. Some strict conditions have been also set for member countries to request exemption from IPI measures for a limited list of local contracting authorities. To this instance, negotiators from the EU Parliament obtained the reduction to only two possible exceptions whereby an authority seeking tenderers in member states can opt out of IPI measures. Big contracting authorities, for example city halls of large towns or the central government, will always have to apply the new rules. Local contracting authorities will only be exempted from the IPI if they represent fewer than 50,000 people. Contracting authorities must always apply IPI for a percentage of annual overall tender value of 80%.

The investigation of bids received from third countries shall consider also social, environmental and labour requirements. Successful tenderers following within the field of IPI’s application will be subject to additional obligations, so to avoid circumvention of the new rules; for example, it shall be precluded to subcontract more than 50% of the total value of the contract. “This puts an end to the long list of prominent examples in which third-country bidders win illustrious public contracts across the EU while their home markets are de facto off limits for EU bidders. The agreement is effective while limiting the administrative burden to a minimum.”, said the EU Parliament’s Rapporteur Daniel Caspary.

Some reasons to overcome current barriers

A more detailed overview of the drafting process that led to the proposed IPI regulation is available in the Briefing document prepared by the European Parliamentary Research Service.

 Previous steps aimed to better support access of European companies to international public procurement markets are represented by the 2014 revised Government Procurement Agreement (GPA) signed at the World Trade Organization (WTO) and various bilateral free trade agreements (FTA), such as the government procurement chapter of the EU-Japan Economic Partnership Agreement (EPA). According to the EU Parliament, these actions led only to mixed results, as many emerging economies may prove reluctant to join the GPA or to open their public procurement markets to the EU bilaterally. Also first line players such as the United States may see public procurement as a legitimate tool to promote domestic production or employment (e.g. the US Buy American Act).

The IPI’s drafting process was resumed in 2019, following concerns about the competitiveness of the European industry vs China, as detailed in the Franco-German manifesto for a European industrial policy. The adoption of the IPI was also among the targets established by the new industrial strategy for Europe, published by the European Commission in March 2020.

According to the Briefing document, in 2016 the EU average for public procurement expenditure was about 13.4%, compared to 16.2% in Japan and 9.4% in the US. Netherlands, Finland and Sweden were the EU countries with the highest levels of public procurement, Ireland, Cyprus and Portugal those with the lowest.

Data also show that in 2018 the value of public procurement of goods, services and works European markets open de jure to bidders from GPA signatories (e.g. Australia, Canada, Japan and the US) amounted to €352 billion (over a total value of €2 trillion). While not having yet joined the GPA, according to the Commission other countries such as Brazil, China, India and Turkey have increased their protectionist measures. These trends points to half of the global procurement market being currently closed to foreign bidders: an important target to be tackled by the IPI regulation, as improved access might more than double EU procurement exports (currently estimated in €10 billion).

Among the main barriers used by third countries to prevent access of European companies to public procurement, the Briefing document mentions the lack of transparency (no online publication of notices or fragmented procedures), a requirement for national establishment such as joint ventures (China, Indonesia) or local establishment (Brazil, Indonesia), local origin requirements (India 50%, Indonesia 50%), the “buy Chinese” policy, etc.



A record year for biotech investments in UK, a year after the Brexit

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by Giuliana Miglierini

One year after the Brexit, the UK’s economic landscape is far from being suffering for leaving the European Union. On the contrary, 2021 has been a record year for many sectors, including UK’s biotech and life sciences. A recent report from the BioIndustry Association (BIA) and Clarivate shows that £4.5 billion was raised in public and private financings in the field, £1.7 bln (60%) more than in 2020.

There is an obvious gap that we must plug in the UK’s financing environment. The large fundraises seen in 2021 are largely the result of welcome overseas investment, meaning that significant value creation will also be offshored. History has handed the UK two world-leading sectors: life sciences and finance. A symbiosis should exist between these two, but it doesn’t, yet. There is great opportunity to turbo-charge the UK’s biotech and life sciences sector and capture more of its economic value for the UK by building better connections between the UK’s financial institutions and our innovative scaling businesses”, said Steve Bates OBE, Chief Executive of the BIA.

A higher attractiveness than the US

More in detail, UK companies attracted more than half of all biotech venture capital in 2021, for a total value in the period 1 December 2020 – 30 November 2021 of £2,518 million (+81%from 2020; 56% of total investments). Even higher has been the increase of Initial Public Offerings (IPOs), for a total of £1,304 million (+434% from 2020; 29% of total); all other public financings raised £684 million (15% of total). Thirteen investment deals were more than £100meach (vs 3 in 2020), and a further 27 raised more than £20 million each (vs 12 in 2020).

The positive trends of investments marked in 2021 are not unique to the UK; the level of venture capital investments raised 10% in the last year compared to 2020, reaching the global value of £28.1 billion for the biotech sector. The attractiveness of the UK reached 79%, compared to 49% for the US’s Boston Massachusetts cluster, while the San Francisco one marked -21%; total investments in the US reached £18.8 billion (+11%). Negative trends characterised Europe (-12%venture investments, for a total of £5 billion) and China (-12%, £3.4 bln).

We value the significant investment that comes from overseas, but we must complement it with the full financial firepower of the City of London so that more companies stay in the UK. This is why our ambitious 2021 Life Sciences Vision sets out our firm commitment to helping UK life sciences and biotech firms access long-term scale-up capital from investors here at home, who are committed to building successful companies. Scaling up UK companies will help both grow our economy and improve access to innovative diagnostics and treatments.”, added George Freeman MP, Minister for Science, Research and Innovation.

Venture capitals looking for new opportunities

The UK has been a key point of innovation during the pandemic, generating many new vaccines and treatment opportunities. The interest of investors in UK’s science is acknowledged by the£128 million invested into startup companies, more than four times the amount seen in previous years. A trend that paralleled later-stage rounds of financings into mature projects.

The bigger deal (£195 mln fundraise prior to the London IPO) involved Oxford Nanopore, a company specialised in the development of innovative sensing techniques based on the use of nanopores embedded in high-tech electronics. These can be used to sequence small or large fragments of DNA and RNA, for example; the platform may be also adapted for the detection of other types of molecules, e.g. proteins.

At the second place is the Exscientia’s deal (£158 mln, round D). The company offers AI-driven drug discovery services aimed to deeply innovate how new medicines are developed. Its AI platform is being used to completely design from scratch new molecules; algorithms are used also to optimise properties in parallel, rather than sequentially, and to reduce the overall development time thanks to the higher capacity of analysis of complex data.

Vaccitech attracted the third deal (£118 mln, round B); the company is the spin-off of the Oxford University specifically created to commercialise the technology platform behind the Oxford/AstraZeneca Covid-19 vaccine.

IPOs reached record values

Oxford Nanopore and Exscentia also represent the higher values for IPOs operated by UK biotech companies in 2021. The former deal worth £350 million, representing the largest amount raised in a listing on the London Stock Exchange by a biotech company. Exscentia attracted a £256mln value at Nasdaq; the total amount raised by UK biotech through IPOs in 2021 reached £1.3billion (42.8% of all the money raised by UK biotechs at IPO in the past decade, a huge amount if compared to the £244 million raised in 2020).

Three companies were listed at the London’s Alternative Investment Market (AIM): Poolberg Pharma (£25 mln) is a clinical stage infectious diseases pharmaceutical company, aiming to become a “one-stop shop” to find Phase II ready products for development and commercialisation. Arecor Therapeutics (£20 mln) has developed a proprietary platform for the reformulation of already available medicines, while BiVictriX Therapeutics (£7,5 mln) is developing new targeted cancer therapies.

When looking at the international scenario, 133 companies raised £19 billion in IPOs in 2021 at the global level (+30% vs 2020). In the US, 86 companies raised £9.7 billion; the most attractive biotech clusters were again Boston Massachusetts and San Francisco. The number of IPOs in Europein creased to 29 (vs 12 in 2020), for a total of £3.3 billion raised (+218% vs 2020); to this instance, according to BIA’s report the UK accounted for 31% of the European IPOs and 40% of the capital raised. No significant changes involved listed companies in China (14), but on this market the average IPO was three-times larger than that achieved by the average American or European listing.

Follow-on financing of quoted biotech companies almost halved in 2021 compared to the previous, record year (£684 million vs £1.18 billion raised, respectively).

A main contribution came from Blackstone’s investement in Autolus at the Nasdaq (£183 million) to support the development of the company’s CAR-T cell therapy currently in Phase III stage of development. A strategic investment of £50 million in Oxford Biomedica, received from the Serum Institute of India, will support the expansion of the advanced therapy manufacturing facilities near Oxford.

Mergers & Acquisitions and Licensing deals

Jazz Pharmaceuticals acquired in 2021 GW Pharma, a company specialised in the development and commercialisation of cannabinoid-based epilepsy treatments. The biotech Kymab, thoseplatform is used for the development of fully-human monoclonal antibodies, was acquired by Sanofi in a deal involving £1,073 million upfront payment and up to $350 million in milestone payments.

The licensing deal signed between AstraZeneca and VaxEquity would allow the multinational company to use the University College London spin-out’s saRNA platform for the development of up to 26 drug targets.

Early-stage biotech companies are often supported by research grants; to this instance UK’s biotech received in 2021 over £50m in non-dilutive grant funding.


ACT EU: the EU’s vision for the future of clinical trials

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by Giuliana Miglierini

Just few days before the entry into force of the new Clinical Trials Regulation and of the Clinical Trials Information System (CTIS) on 31 January 2022, a new initiative has been announced to completely renew the European framework governing how clinical trials are designed and run. The strategic document ACT EU (Accelerating Clinical Trials in the EU) has been jointly developed by the European Commission, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and national regulators with the aim to strengthen the European Union as a leading “focal point” for clinical research at the international level.

ACT EU shall support the achievement of the goals established by the European Pharmaceutical Strategy and the European medicines agencies network strategy (EMANS) to 2025. The initiative will be co-led by the European Commission, EMA and HMA; the proposed governance shall find inspiration on the model already in use by the Clinical Trials Information System, with an EUCTR Coordination Group with an adapted mandate and composition. The individual domains which form the overall matrix will be coordinated by the relevant functions available within the network. The formal public communication phase on ACT EU will start after the official endorsement of the initiative by HMA and EMA.

Six objectives and ten priorities of action for 2022-2023

The ACT EU strategy identifies six different goals for the future of European clinical research. Its leading role shall be optimised through a unified European position on clinical trials at the international level, a better ethical oversight and integration of ethics committees into the clinical trial and medicines regulatory lifecycle. Large-scale multinational clinical trials with broader geographical scope shall be incentivised, while reducing the administrative burden for sponsors and investigators.

A special attention will be paid to the generation of decisional evidence for unmet medical needs, rare diseases, and on vaccines and therapeutics for public health crises and pandemics. A truly high level and coordinated scientific advice is indicated as an important element in order to support the trial and marketing authorisation processes. The strategy confirms the need to adopt new patient-oriented medicines development and delivery models with pro-active engagement of all the stakeholders. The availability of an improved capacity both at the development and regulatory level is also deemed important to achieve the goals of the initiative.

These challenging objectives shall be pursued in years 2022-2023 through the activation of a set of ten specific priority lines of action. An initial exercise to map already existing initiatives within the European medicines regulatory network (EMRN) will be run, that will represent the basis for the consequent development of a governance rationalisation strategy. This might include, for example, the alignment of different expert groups and working parties in the EMRN and ethics infrastructure.

The smooth implementation of the Clinical Trials Regulation shall be monitored using a set of Key Performance Indicators (KPI), still to be developed; the modernisation of the good clinical practices (GCPs) should occur under specific ICH’s guidance. The attractiveness of Europe for larger, multinational trials should specifically address studies run in the academic setting. Furthermore, the academics and non-profit organisations may also play a leading role in the analysis of data arising from clinical trials.

Further actions will include the availability of a multi-stakeholder platform, including patients, and the engagement in the initiative of all enablers by mean of a targeted communication campaign. A tighter coordination of different aspects relevant to the planning of new clinical trials, i.e. the scientific advice on the trial approval and the design of the study, has been also announced. The increasing use of artificial intelligence and/or machine learning technologies in the clinical domain and issues pertaining complex and decentralised trials, as well as the interface between the In Vitro Diagnostics Regulation (IVDR) and the Clinical Trials Regulation will benefit of new targeted methodological guidelines.

As for safety monitoring of clinical trials, the priority is to start its integration into a pre- and post-marketing safety monitoring framework. At the educational level, the competences needed to face this challenging scenario for the future of clinical trials in the EU will require the activation of specific training curricula, inclusive of modules on drug development and regulatory science with links to universities and SMEs.

Four principles to guide all actions

The complexity of the ACT EU initiative will require also the development of a new approach to make available the resources needed to smoothly run all the planned activities, possibly including the exploitation of the expertise external to the European medicines regulatory network. The strategy indicates the intention to adopt a collaborative and integrative approach, so to achieve a large research impact in the EU.

To this instance, the four principles “Do, Require, Influence, Support” have been identified to guide the execution and coordination of the projects, the requirement of specific guidance to address the expectations on applicants/developers/researchers, the availability of key publications and leadership to support the transformation phase at all levels (including patient, the academic, etc.), and stakeholders interactions suited to support all the above mentioned objectives.

The initial mapping of existing activities should also led to the identification of the budget needed for meetings, inclusive also of the activities relative to stakeholder engagement, training, and communication. Any other activities falling outside the optimisation of the already existing ones would be self-funded by the respective organisations (EC/NCA/EMA).

Comments from EFPIA

According to EFPIA, the announcement of ACT EU represents the beginning of an exciting new phase for clinical research in Europe. The industrial association highlights that the innovative design of many clinical trials, especially the complex ones, requires an increased efficiency.


Steps towards the final approval of the IP action plan

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By Giuliana Miglierini

The end of 2021 may see the final approval of many pieces of the new legislative framework announced in November 2020 by the European Commission. An important piece of this puzzle is represented by the IP Action Plan, governing the protection of intellectual property (IP); a step forward in this direction is represented by the resolution of 11 November 2021 on the Own-initiative report of the European Parliament.

The final text licensed in single reading is the result of the examination of the initial draft report – issued in May 2020 by the Committee for Legal Affairs, rapporteur Marion Walsmann – by several other Committees (IMCO, DEVE, CULT, AGRI).

The main points of the resolution

The resolution recognises the importance for the European economy of a balanced protection and enforcement of intellectual property rights (IPR). In years 2012-2016, the knowledge-intensive industries generated almost 30% of all jobs and almost 45% of total economic activity (in terms of Gross Domestic Product, GDP) in the EU; the IPR-intensive industries account for 93% of total EU exports of goods.

Europe’s recovery and resilience capacity is also highly impacted, as demonstrated by the pandemic when shortages of certain medicinal products and vaccines occurred. The EU Parliament acknowledges the role played by intellectual property in increasing the overall value of companies,especially the small-and-medium size ones (SMEs).

A current limitation to IP protection in Europe is represented by the still fragmented situation across different member states, which often leads to parallel national validation procedures and litigation for European patents. To this instance, the Parliament suggests the establishment of an IP coordinator at European level, to harmonise the approach to EU IP policy and enhance cooperation between the different bodies involved in the process (i.e. national IP authorities, Commission Directorates-General, EPO, EUIPO, WIPO, etc).

The Parliament also recognised the role IP plays in the pharmaceutical sector, where the availability of incentives greatly favours the development of new and innovative treatments. The resolution asks the Commission to support the innovative potential of European companies “on the basis of a comprehensive IP regime”, so to guarantee effective protection for R&D investments and favour fair returns through licensing. The availability of open technology standards has been valued as an important competitive element on the wider, global scenario.

Many different types of incentives are suggested by the Parliament’s resolution as useful to support micro-enterprises and SMEs in filing and managing their intellectual property, including IP vouchers, IP Scan and other Commission and EUIPO initiatives to support simple registration procedures and low administrative fees. The newly created European IP Information Centre may represents a fundamental reference point to increase knowledge in the field. The Parliament also suggests to introducing an EU-level utility model protection, not yet available, as a possible fast and low-cost protection tool to protect technical inventions.

Unitary patents and improved market competition

Still missing members states are urged to adhere to the enhanced cooperation scheme for the creation of a Unitary Patent Protection (UPP) and to ratify the Protocol to the Agreement on a Unified Patent Court on provisional application (PPA). The activation of this unique Court in charge of the examination of litigations would allow for a more efficient process and for lowering legal costs and improving legal certainty.

Fragmentation remains an issue also with respect to Supplementary Protection Certificates (SPCs): to this instance, the resolution asks the Commission to issue guidelines for member states and to provide a legislative proposal based on an exhaustive impact assessment. A major criticality to be solved is represented by the unitary patent not providing a unique SPC title valid across the EU; the own-initiative report also suggests the extension of the EPO’s mandate, so that examination of SPC applications could be carried out on the basis of unified rules.

Other important points needing attention to improve the presence of generic and biosimilar medicines in the EU are the abuse of divisional patent applications and patent linkage, which should also see an intervention by the Commission. The Parliament also opened the possibility of a revision of the Bolar exemption, which allows clinical trials on patented products needed to reach marketing authorisation of a generic or biosimilar version not to be regarded as infringements of patent rights or SPCs. This may also support the immediate market entry after the expiration of patent rights and SPCs. The Commission is called also to ensure the effectiveness and better coordination of compulsory licensing in order to provide access to medicines needed in case of health emergencies.

The resolution also addresses the theme of standard essential patents, which currently often leads to litigations, and it calls for the revision of the 20-years old system for design protection. Transparency on results obtained from publicly funded R&D is also recommended. The Parliament suggests artificial intelligence (AI) and blockchain technologies may play an important role in tackling counterfeiting practices and guarantee traceability of goods, as they may contribute to a better enforcement of intellectual property rights along the whole supply chain. The Commission should also work to establish clearer criteria for the protection of inventions created by the AI, without human intervention.

Comments from the industry

The European Parliament has clearly voted for a strong and fair IP system by underlining the importance of timely generic and biosimilar medicine competition. The misuse of divisional patents, the need to enlarge the scope of bolar to include API and all regulatory and administrative steps, and the long overdue ban anti-competitive patent linkage are well known problems that the Commission should address in the IP Action Plan. The Parliament has voted; the Commission must act.”, said Adrian van den Hoven, Director General at Medicines for Europe.

A major point in the implementation of the new European policies is represented by the review the Commission is going to conduct in 2024 to assess the effective achievement of goals of the SPC manufacturing waiver, which entered into force in July 2019 and is expected to start producing effects in the second half of 2022.

Many of the themes discussed in the Parliament’s resolution were debated during a webinar organized by Medicines for Europe, with the participation of representatives from the European Commission and the European Patent Office.

EFPIA, representing the innovator pharmaceutical industry, focused its attention on the impact of past EU Free Trade Agreements (FTAs) on drug spending, timing of countries’ access to new medicines after global launch, investments overall and in pharmaceuticals, and clinical trial participation. A report by IQVIA published in the Federation’s website addresses the impact of IP protection on these elements. Results confirm the central role of the pharmaceutical sector as the most R&D intensive industry in the world, with R&D spending averaging over 15% of revenue. A strong IP protection framework available at the level of EU FTAs favours the attractiveness for investments in the EU and its FTA partner countries. According to the report, an expanded IP protection appears not to be linked to the generation of a higher pharmaceutical spending; drugs’ share of healthcare spending is claimed to stay flat or fall after an FTA, and prices for medicines to rise more slowly than the level of inflation. A stronger IP index, adds IQVIA, is also correlated with increased clinical trial activity in a country, bringing both clinical and economic benefits.


A step forward towards the African Medicines Agency

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by Giuliana Miglierini

Cameroon has been the fifteenth African country to formally ratify on October 5th the Treaty for the establishment of the African Medicines Agency (AMA). The reaching of this target enables the implementation phase of the project, that should lead AMA to be operative in 2022. The Treaty is now going to come into force 30 days after the deposit of the last instrument of ratification and will lead to the activation of all conditions needed to run the Agency.

Twenty-six African countries (mainly Francophone) are supporting the initiative (on a total of 55); three countries still need to just formally inform the African Union (AU) of the ratification, while other eight are expected to ratify the already signed Treaty. Among important African countries that have not yet supported the creation of AMA are Ethiopia, Nigeria and South Africa.

A regulatory Agency to support the African growth

The Treaty was signed in 2019 by the Assembly of Heads of State and Government of the AU; AMA will represent the central African regulatory body in charge of the supervision of medicines’ development, production and approval in adhering countries, a key milestone for the development in the Continent of a robust vision of the entire life cycle of medicinal products.

The African Medicines Agency will add to the already existing Africa Centres for Disease Control and Prevention (Africa CDC), the specialised technical institution of the AU established in 2016 and launched in 2017 as a platform to share and exchange knowledge and lessons from public health interventions. The activities of AMA shall also contribute to the proper functioning of the African Continental Free Trade Area (AfCFTA), the largest integrated trading area in the world which should represent the basis for the creation of an African Economic Community (expected to occur by 2028).

Africa should experience a rapid growth of the urbanising population, with total projections at 1.2 billion people. Substandard and counterfeited medicines still remain a relevant issue to be addressed by the newly born Agency, with estimates of over US$30 billion annual earnings (data WHO 2017). A main reference for AMA’s activities shall be also found in the Pharmaceutical Manufacturing Plan of Africa (PMPA), endorsed by the Heads of State and Government at the summit in Accra in 2007 and aimed to support a robust framework for the creation of an African pharmaceutical industry.

The process to create the African Medicine Agency started in 2014, with the goal to prioritise investment for regulatory capacity development and find convergence and harmonisation of medical products regulation in countries adhering to the Regional Economic Communities (RECs), within the context of the African Medicines Regulatory Harmonization (AMRH) initiative.

AMA will act as a specialised agency of the African Union – exactly as the European Medicines Agency is for the EU – with its own rules, membership and resources to enhance the capacity of member states and RECs to regulate medicinal products. Its activities shall help the coordination of on-going regulatory systems, provide regulatory guidance, and improve access to qualitative, safe and efficient medicinal products on the continent. The city that will host AMA will be selected upon examinations of the bid offers received by members of the Conference of the State Parties.

The Conference shall also act as the highest policy-making organ of the AMA, entitled to determine the composition, sessions, functions and terms of office of the AMA Governing Board. This last body will include five Heads of National Medicines Regulatory Authority (NMRAs) from each region, one Regional Economic Community (REC) representative, one representative of Regional Health Organization (RHOs), one representative of National Committees Responsible for bioethics on rotational basis and the Commissioner for Commissioner for Health, Humanitarian Affairs and Social Development (HHS) at the African Union Commission (AUC). The Conference of the State Parties shall also appoint AMA’s Director General, upon recommendation of the Governing Board.

Open issues waiting for the action of AMA

The weakness and fragmentation of current legislative frameworks active in African countries, is leading to redundant and/or duplicate procedures, slow and inefficient medicine registration processes, and limited technical capacity. These critical issues were already been identified in 2009 by the African Medicines Regulatory Harmonisation initiative (which is part of the PMPA).

An article published in the Journal of Pharmaceutical Policy and Practice discusses the actual status and the challenges and regulatory readiness be faced during the implementation of the African Medicines Agency.

The AU Model Law on Medical Products Regulation established by the African Union shall represent the reference for the alignment of national legislative frameworks, in order to proceed towards a better harmonisation of rules governing the pharmaceutical sector. Under the current status manufacturers submit the regulatory dossiers in each country, as no mutual recognition procedure is in place for the approval of medicinal products. This leads to a great duplication of efforts, with higher costs and time-consuming procedures.

The Sahrawi Republic is the only African country not to have a national regulatory authority or an administrative unit in charge of this type of functions; the great majority of countries (>90%), explains the article, have minimal to no capacity, and only 7% have moderately developed capacity, thus highlighting the importance for the new central Agency to provide support also in the form of training provided to national NMRAs. Ghana and Tanzania are the only countries to possess NMRAs operating at maturity level 3 (over a total of 4) of the WHO’s Global Benchmarking Tool (GBT). Fragmentation is also present in the type of medicines falling under the mandate of each NMRA, including veterinary drugs, traditional and herbal products, foods, cosmetics, food supplements, etc. Issues shall also to be addressed for their registration of innovative medicines, i.e. biosimilars, vaccines or advanced therapies.

Among recommended priorities for AMA is the assessment of the current status of implementation of the AU Model Law by AU member states, the examination of the enabling factors and challenges encountered in implementing the Model in each country, the analysis of factors impacting on the ratification of the Treaty, a comparative study to gain experience from the implementation of other continental initiatives, and an investigation of African NMRAs’ expectations, perceived contributions in/to AMA and perceived benefits for each country, and which may potentially derive from the new Agency.

A partnership for health innovation in Africa

The development of a framework to strengthen the African capacity for drug discovery and development – by scaling existing initiatives and identifying new development opportunities for young and mid-career scientists – is central to the new three-year partnership launched by the H3D-Foundation (H3D-F, established to reduce barriers for health innovation in African countries) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

The project will start from the results achieved up to now by the University of Cape Town Holistic Drug Discovery & Development (H3D) centre, the only integrated drug discovery and development platform in Africa. The new partnership with IFPMA shall contribute to expand this capacity.

Focusing on infections, an area highly relevant medical need in Africa, local research currently represents approx. 2% of the global effort on new infections. There are 250 research sites and 73 vaccine clinical trials active in Africa, but less than 10 universities provide vaccinology courses and only two local universities engage in vaccine-related pre-clinical studies.


First steps of the HERA Authority and comments from industrial and medical associations

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by Giuliana Miglierini

The new European Health Emergency preparedness and Response Authority (HERA) has started its operative phase. Initially launched in February 2021, HERA has been modelled by the European Commission on the example of the US’s DARPA agency, and it will be in charge of anticipating threats and potential health crises.

The first three calls for tender to support HERA’s setup have been published on the Commission’s website and will remain open until 29 October 2021. They are targeted towards addressing different aspects of the management of Covid-19 therapeutics and antimicrobial resistance.

A total sum of €7 million from the EU4Health programme will fund these activities. An info session on the three calls was delivered on 14 October 2021 by European Health and Digital Executive Agency (HaDEA) in collaboration with DG Santé (see more at this link). A summary of HERA’s activities in the field of crisis preparedness and emergency response is also available here. A budget of €6 billion from the current Multiannual Financial Framework 2022-2027 is available to fund HERA’s setup and activities, plus additional support from other EU programmes, for a total of almost €30 billion. HERA will be part of the internal Commission structure, and it is expected to become fully operational in early 2022.

HERA’s role is to improve the EU’s development, manufacturing, procurement and distribution of key medical countermeasures said the Commissioner for Health, Stella Kyriakides, following the recent Informal Meeting of Health Ministers in Ljubljana, Slovenia -. HERA will also be crucial in ensuring accessibility and availability of medicines. As I said to Ministers today, HERA is a joint undertaking, with Member States, EU Agencies, the European Parliament and other concerned stakeholders, including industry and civil society. HERA’s strength and success will come from our joint preparedness and joint response, and our capacity to bringing joint solutions. HERA is now operational and should be fully up and running early next year.

HERA’s first activities

The call for tender on antimicrobial resistancerefers to a service contract to run a study comprehensive of a technological review of the latest AMR medical-countermeasures (e.g.; medicines, medical devices, vaccines) and a gap analysis and assessment of needs amongst the EU Member States and key stakeholders. The study shall also include options for possible actions, funding and provision of support mechanisms, and exploration of available tools suitable to ensure the availability of safe and effective products in the European market. These products are expected to be immediately available to the EU and member states in the event of a public health emergency. The estimated total value of the tender is €1 million.

Stockpiling of medical countermeasures in the area of AMR is the subject of the second feasibility study (estimated total value €1 million). The study shall analyse physical stockpiling solutions compared to other options, providing identification and assessment of all available opportunities. The needs and availability of AMR countermeasures shall be also assessing, both at member states and EU level, as well as the mapping of relevant stockpiling systems currently operated at EU and/or global level (e.g. WHO). Possible funding mechanisms (including procurement options), identification and assessment of operational deployment mechanisms and considerations on liability and regulatory aspects and/or constraints are also to be included in the study.

The third feasibility study has the higher estimated total value (€5 million) and will focus on the design and prototype development for a mapping platform on Covid-19 therapeutics in the EU. The platform is expected to map the production capacity and supply of products intended to treat Covid-19, both already on the market and in R&D phases. Possible examples include ICU medicines, heparin, dexamethasone and antibiotics, in vitro diagnostics devices and/or companion diagnostics.

Comments from stakeholders

Many stakeholders released their comments to welcome the creation of the new Authority.

The creation of HERA is a first step to putting Europe on the front foot in addressing global health threats.”, said EFPIA Director General, Nathalie Moll. “The speed at which Europe became the epicentre of the Covid-19 crisis meant, as a region, we were simply reacting to issues as they arose, working together to find solutions as quickly as possible”.

The lessons learnt during the pandemic revealed a number of weaknesses in Europe’s ability to respond to a public health crisis. HERA’s ability to balance coordination and unity with agility and responsiveness as threats emerge shall be central to its success, according to EFPIA. The Federation, together with Vaccines Europe, supports an end-to-end approach to govern HERA’s activities, and a collaborative, partnership-based model to maximise the strength of each stakeholder in a highly coordinated approach.

The association representing the generic and biosimilar industry, Medicines for Europe, wrote in a note that HERA should “be an efficient agency with strong links to healthcare industries”. A joint industrial cooperation forum to coordinate interactions of manufacturing associations and EU authorities, a regulatory framework able to prioritise the supply of essential medicines and the elimination of the proposal for redundant manufacturing capacity are just some suggestions made by the Association, which is more favourable towards manufacturing investment in a wide range of medicine production types, as outlined in the Structured Dialogue.

Reserve policies should be also revised in order to avoid waste, costly destruction, and distorting supplies of medicines to certain (smaller) EU countries. The functioning of joint procurement system should be also addressed and improved by the Commission, to avoid distortions in the internal market and provide accurate demand estimates.

The Federation of the European Academies of Medicine (FEAM) published in May 2021 a report jointly prepared with the Wellcome Trust, highlighting the opportunity in the short term not to overstep HERA’s role in relation to others European authorities (e.g. the European Centre for Disease Prevention and Control) as a pre-requirement to ensure its success.

The new-born Authority should also try to harmonise the European research and development landscape for pandemic preparedness and response, in order to remain “relevant and active between emergencies”.