public-private partnerships Archives - European Industrial Pharmacists Group (EIPG)

A new member within EIPG


The European Industrial Pharmacists Group (EIPG) is pleased to announce the Romanian Association (AFFI) as its newest member following the annual General Assembly of EIPG in Rome (20th-21st April 2024). Commenting on the continued growth of EIPG’s membership, EIPG President Read more

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

Lessons learnt to transition from Horizon 2020 to the new FP10

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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 account in the definition of the new FP10 (2028-2034) that will follow the current programme Horizon Europe (FP9). Among these are a broader participation, further simplification and reduction of the administrative burden, reinforcement of the dissemination, exploitation and deployment of results, support for the participation of women and enhancement of synergies with other initiatives at EU, national and regional level.

With a overall budget of € 75.6 billion, the main goal of H2020 was to support EU’s economic growth and excellence in science, industrial leadership and societal challenges. We summarise the main features of the report.

Key numbers of Horizon 2020
Calls under H2020 collected more than a million individual applications from 177 countries. Funded projects were more than 35,000, involving more than 40,000 organisations. The true impact of the programme cannot yet be fully appreciated, as 41% of projects were still active at the time of the final evaluation and are expected to yield further results.

Many new technologies in various domains of science were developed thanks to H2020 funding, i.e. mRNA vaccines, photonics and micro- and nanoelectronics, and novel hydrogen-fuelled transports. Sustainable development benefited from investments equal to 64.4% of H2020’s budget.

Activities run under FP8 led to almost 4,000 applications for protection of intellectual property (¾ patents and 12% trademarks). Peer-reviewed publications were over 276,000. Horizon 2020 had a significant effect in boosting employment (+20%) and increasing the turnover and total assets for participating companies (+30%). The mobility of approx. 50,000 researchers across countries and sectors was also supported. The programme allowed to improve the access to newly created or upgraded research infrastructures for more than 24,000 researchers and organisations.

According to the final report, some additional € 159 billion would have been needed to fund all the high-quality proposals submitted. Despite this, the long term impact of the programme is estimated to contribute an average annual increase of €15.9 billion to EU GDP (€429 billion for the period 2014-2040), and a net gain in employment levels of around 220,000 employees at its peak.

Co-investment led to a wide development of public-private partnerships and joint undertakings, with private partners contributing resources (in cash or in kind) two-three times the volume of EU funding. The development of the venture capital ecosystems and networks was also improved.

Key scientific and societal achievements
Medical sciences, quantum mechanics, chemical engineering and composite materials were among the main scientific domains targeted by actions run under Horizon 2020, together with climate change, health and food security and other societal challenges.

The relevance of scientific publications is acknowledged by the citation frequency, that according to the report is twice the global average. A significant number of papers (4%) are among the most cited worldwide, while more than 25% covered emerging and rapidly evolving R&I sectors. The great majority of publications (82%) were published as open access papers, thus greatly supporting the circulation of knowledge.

Emerging health crises were among the main research priorities related to improvement of public health, together with rare diseases and personalised medicine. Ebola and Zika epidemics were the first targeted emergencies, but the real test case was the Covid-19 pandemic: the final report indicates H2020 and the previous FP7 are recognised as the third most frequently acknowledged funding sources for Covid-19 related research in the world.

As for climate change, this field of research received 32% of H2020 funding to support, among others, the development of alternative and low-emission fuels. Other relevant lines of R&I included the development of a smart European electricity grid, automation, energy storage integration and the adoption of renewable energy sources.

As for the ongoing digital transformation, H2020 supported for example the development of safe and user-friendly robotics. Over 20% of the overall budget was dedicated to research in social sciences and humanities disciplines.

Elements to be improved
Horizon 2020 allowed to greatly expand the European network of research infrastructures. According to the final evaluation, access to these facilities may be further improved by enabling greater synergies between EU, national and regional programmes for research infrastructure. Despite H2020 saw improvements in the presence of women in evaluation panels (42%), the fixed target of 50% share of women in scientific advisory panels and as researchers in projects was not yet achieved (43% and 23% respectively).

As for financial aspects, the interim evaluation identified a notable gap in venture and growth capital in the EU to scale up innovations. The issue was addressed through the launch, in the last three years of H2020, of a pilot to run the European Innovation Council (EIC), which according to the report showed positive preliminary results both on the turnover and staffing levels of its beneficiaries, and in tackling the critical funding gap in high-risk areas where limited alternatives are available at national and regional levels.

Preparing for the next FP10
With Horizon Europe framework programme coming to an end in 2027, the final report on results achieved by H2020 represents a first basis to reason on new research targets and financial support to be part of the new FP10 2028-2034 (you can find comments here and here).

While some members of the European Parliament already called for a FP10 budget of at least € 200 billion (see here more), several academic and scientific organisations published their proposals to be considered in the drafting of the new programme.

The European University Association (EUA), Science Europe and the European Association of Research and Technology Organisations (EARTO) sent a joint open letter to EU Commissioner Iliana Ivanova, asking for a doubling of the FP10 budget to €200 billion. A higher budget stability and protection of funding from being shifted to non-R&I purposes are among other requests, together with rebalancing support across various stages of R&I (i.e. bottom-up basic research, applied research, development, and innovation). Sufficient national investments in R&I are also deemed important.

The European universities of science and technology represented by Cesaer also published a note to advance their suggestions, in line with the EU Commission’s goals of a more elaborate EU industrial policy, and the move towards EU-30+. Key elements should include the leadership in deep tech, clean-tech and biotech based on the full knowledge value chain, the use of open and competitive calls to select researchers and innovators and award funding across all parts of FP10, a stable financial environment with at least €200 billion investments and enacting the 3% GDP target to R&I agreed by the EU Council in 2002. An annual review mechanism of current performance and a ring-fence to protect the budget allocated to R&I are among the suggested actions.

Guiding principles proposed by EU-LIFE (the Alliance of research institutes advocating for excellent research in Europe) also address investments in the European Research Council, the bridging role of the European Innovation Council, the need to avoid additional pillars and fragmentation, and the development of a coherent impact approach by reducing the size of consortia and monitoring the impact of initiatives in Pillar 2.


ICMRA report on best practices against antimicrobial resistance

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by Giuliana Miglierini

Antimicrobial resistance (AMR) is the consequence of mutations that allow microbes to survive pharmacological treatment. Resistant strains can often be tackled only by a limited number of therapeutic options: according to a systematic analysis published in The Lancet, an estimated 1.27 million deaths occurred in 2019 due to unresponsiveness to available medicines.

As a part of its effort against AMR, the International Coalition of Medicines Regulatory Authorities (ICMRA) has published a report discussing successful regulatory and non-regulatory best practices in the field of AMR.

The report was drafted by ICMRA’s Work Group led by Health Canada, and inclusive also of the European Medicines Agency, UK’s MHRA, and regulators from Japan, Argentina, Nigeria, Saudi Arabia and Sweden. For each of the nine case studies, Annex 2 presents a table summarising the problem under examination, the proposed solution, results and consequent recommendations.

Regulatory flexibility

The US’ Biomedical Advanced Research and Development Authority (BARDA) focused on innovative approaches to developing supporting data packages required for regulatory review of certain non-traditional therapies. Public-private partnerships are the preferred vehicle to manage R&D projects and to reach regulatory approval by the FDA. The main targets for BARDA are new antimicrobials to treat antibiotic-resistant secondary bacterial infections and bioterrorism infections. Selected proposals shall lead to the development of candidate medical countermeasures (MCMs), based on a regulatory master plan inclusive of a tentative schedule for regulatory milestones. Partners may also benefit from BARDA’s expertise in the field of animal studies, flexible manufacturing and clinical study design. A Memorandum of Understanding was also signed with the FDA to provide a coordinated framework for the development of MCMs.

Antimicrobials for veterinary use

Antimicrobials for veterinary use include some products for human use. It is thus important to act in the animal sector to limit the selection pressure for the development and spread of resistant pathogens in both animals and humans.

The project led by Health Canada in collaboration with the Public Health Agency of Canada (PHAC) focused on the implementation of the Veterinary Antimicrobial Sales Reporting (VASR) system, aimed to collect data on the total quantity of antimicrobials sold or compounded by animal species. The activation of the system in 2018 followed some changes to Canada’s Food and Drugs Regulation (FDR): manufacturers and importers have to report annual sales of medically important antimicrobials intended for veterinary use based on active ingredients listed in List A. The acquired data are collected and screened by the Veterinary Drugs Directorate and validated and analysed by PHAC’s CIPARS.

Regulatory agilities during the Covid-19 pandemic

Regulatory flexibility has been one of the main tools used to respond to the Covid-19 pandemic. Health Canada’s main goal was to expedite the regulatory review of health products without compromising their safety, efficacy and quality standards. A temporary regulatory pathway was introduced in September 2020 by a Interim Order, and new transition measures were approved in September 2021 to allow the review, authorisation and oversight of Covid-19 medicines under the FDR. A procurement strategy for Covid vaccines, treatments and diagnostics was also adopted by the Government, based on advanced purchasing agreements with different companies. Another Interim Order allowed the activation of a temporary regulatory pathway to facilitate clinical trials of candidate Covid-19 products. Flexibilities to Drug Establishment Licensing (DEL) and GMPs were also introduced, and collaborations with other international regulatory bodies activated (including the EMA open pilot).

Non-prescription availability of antibiotics

UK’s MHRA focused on the case of tyrothricin-containing lozenges, a combination product available for sale at pharmacies since 1968, and that underwent a restriction of prescribing in 2018, following a NHS’s guidance advising prescriptions for the treatment of acute sore throats should not be routinely offered in primary care. The UK’s Commission on Human Medicine considered MHRA’s request of advice on the feasibility to remove the product from the market. As a result, the MHRA interacted with the Marketing authorisation holder to verify the possibility of a reformulation to exclude the antibiotic active ingredient. The action of impacted also on the education of the wider public towards the responsible use of antibiotics.

Reimbursement models for novel antimicrobials

The Public Health Agency of Sweden addressed the issue of antimicrobial market failure. Not all the few available antibiotics launched during the last decade are accessible in all European countries, due in some instances to unfavourable sales prospects. A pilot project was launched in 2018 to test a new, partially delinked reimbursement model based on a minimum annual guaranteed revenue at nation level for the pharmaceutical company (on the basis of estimated clinical needs). Security of supply of antibiotics within 24 hours and a security stock located in Sweden were the requests to interested companies.

Selective antibiograms to inform antimicrobial choice

The choice of the most appropriate antimicrobial is usually based on an antibiogram, a laboratory test used to evaluate the susceptibility and resistance profile of bacterial isolates to various antimicrobial active ingredients. The Swedish Medical Products Agency (SMPA) focused on the use and selective reporting of antibiograms of urinary cultures for Enterobacteriaceae from patients with symptoms of cystitis. The analysis included six different antibiotics for men and five for women, since the fluoroquinolone ciprofloxacin is no longer recommended to treat cystitis in women. This selective reporting allowed to decrease fluoroquinolone prescriptions of 46% in 15 years.

Feedback on prescriber data

SMPA also provided some feedback to prescribers on their antibiotic prescribing practices. The tool was implemented at the national, regional, local and also individual level, in order to raise knowledge and information, and influence prescription habits. Prescribers’ data at a high resolution level (prescriber identifying codes) are used to elaborate relevant trends. Statistics on antibiotic use at regional and national level are freely accessible at the National Board of Health and Welfare website.

Common infections in outpatient care

The Sweden’s Rainbow Pamphlet provides treatment recommendations for common infections in outpatient care. The initiative was launched in 2010 by the Swedish Strategic Programme for the Rational Use of Antimicrobial Agents and Surveillance of Resistance (STRAMA); it can be accessed in paper form or through the STRAMA mobile application. The use of the Rainbow pamphlet has been supported also by communication campaigns targeted both to healthcare professionals and the public.

Methods for monitoring AMR in the environment

The monitoring of antibiotics’ diffusion in the environment is relevant with respect to the One- Health approach, which focuses on the harmonised surveillance across human, veterinary and food sectors.

The SMPA launched two projects aimed to better identify indicators to be used for the monitoring of antibiotic resistance in the environment: EMBARK (Establishing a Monitoring Baseline for Antimicrobial Resistance in Key environments) and Antibiotikasmart Sverige (Antibiotic Smart Sweden). The current main gaps in knowledge include the abundance and prevalence of antibiotic resistance genes (ARGs) and mobile genetic elements (MGEs) occurring naturally. Furthermore, antimicrobials may enter the environment at different points along the lifecycle of human and veterinary medical products, with processes still to be fully clarified.