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EMA to revise policies on competing interests

Giuliana Miglierini
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EMA to revise policies on competing interests

The consultation on EMA’s draft revised ‘Policy 0044’ on handling of competing interests of scientific committee members and experts closed on 10 November 2024; its final version is expected by the end of 2024. The revision followed recent court rulings (i.e. the appellate judgements of the Court of Justice in Joined Cases C-6/21 and C-16/21 P and Case C-291/22 P) and aims to ensure alignment with the Court’s findings. The policy refers to the competing interests of members, alternates and experts involved in several EMA’s scientific committees, working parties and other groups (e.g. SAGs, AHEGs, ETF, MSSG, MDSSG).

The revised policy confirms the prohibition for individuals currently employed by or holding financial interests in a pharmaceutical company from participating in the Agency’s activities. In case of other interests (e.g. role of investigator or close family member’s interests), pre-defined restrictions can be applied, for example in case of any current interest in a product or products in the same declared condition. In such instances, experts will be excluded not only from final deliberation and voting but also from discussions, in a consistent manner across all EMA activities and roles.

In case of past employment in a pharmaceutical company, past consultancy or strategic advisory role and past activity as (principal) investigator, a unified three-year cooling-off period will be applied. EMA also proposed to similarly extend these provisions to experts from the medical device industry involved in EMA’s activities.

In UK £400 million investment to boost clinical trials

Giuliana Miglierini
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In UK £400 million investment to boost clinical trials

Eighteen new clinical trial hubs, so-called Commercial Research Delivery Centers (CRDCs), to speed up the pace of research and a total public-private investment program of up to £400 million launched at the end of August by the UK government: these are the figures put in place to support faster patient access to new treatments, the strengthening of the UK clinical trials sector and local pharmaceutical manufacturing.

What the voluntary program involves

The program is based on the agreement reached between the UK government’s Department of Health and Social Care (DHSC), NHS England, and the Association of the British Pharmaceutical Industry (ABPI) and is known as the Voluntary Scheme for Branded Medicine Pricing, Access, and Growth (VPAG). At the heart of it is the expectation that the total expected amount of investment will be spread over the five years of the Voluntary Scheme of 2024, in addition to the payments already planned. Most of the funds (about 75 percent) will be allocated to clinical trials, in addition to drug manufacturing (20 percent) and health technology assessment (about 5 percent).

In addition, within the first three years of the new scheme, the UK PharmaScan platform is also expected to be created, aimed at supporting UK regulatory authorities, HTA bodies, and the local health system in horizon scanning activities. The platform will receive data on medicines in development from scheme participants. A cross-government working group with industry participation as well, aimed at ensuring that HTA and payer processes remain aligned with emerging regulatory pathways, should also be established within the first year of operation. Finally, the increased focus on the end-to-end pathway should help better delineate how to reach the market, how to align commercial development pathways with HTA, and what are the mechanisms for industry involvement.

Industry comments

According to ABPI, the program should allow patients better opportunities to participate in commercial trials. Researchers, on the other hand, will have access to the most innovative equipment and technologies and thus be able to design clinical trials that see an increasing interconnection between hospitals, the primary care network, and community and residential care settings.

Funds for manufacturing will be aimed at developing sustainable manufacturing initiatives, with promotion of efficiency and reduction of waste and emissions from the pharmaceutical sector.

In the field of HTA, the goal is to modernize processes and support the HTA Innovation Laboratory of the National Institute for Health and Care Excellence (NICE).

Romania entered the Unitary Patent system

Giuliana Miglierini
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Romania entered the Unitary Patent system

Romania is part of the Unitary Patent (UP) system since 1 September 2024, meaning that from that date all European patents with unitary effect will automatically cover also Romania. The country is the 18th participating EU member state to the UP system, adding a market of approx. 19 million people to the 330 million already covered. The instrument of ratification was deposited on 31 May 2024 by the Romanian government. Over 1,000 users already requested a delay in registration until after 1 September in order to protect their products also in Romania. 

The Unitary Patent entered into force on 1 June 2023; since then, the EPO has received over 34,000 requests for unitary effect and registered 33,000 UPs. Data from the European Patent Office (EPO) show that, in the first half of 2024, 63% of all requests for unitary effect originated from the 39 EPO member states. Around one third of the applications were filed by small businesses and individual inventors. The UP system, together with the Unified Patent Court (UPC), allows for a streamlined procedure at lower costs, uniform protection and greater legal certainty across participating EU member states.

The EU Innovation scoreboard 2024

Giuliana Miglierini
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The EU Innovation scoreboard 2024

The European Commission has published the EU Innovation Scoreboard 2024 (EIS), the annual report that since 2001 takes stock of the research and innovation (R&I) activities in the different member countries, as well as some neighbouring countries and third countries of particular competitive significance.
The EIS data can also be browsed online at this link; the interactive tool allows for a comparison of scores for specific areas of interest and allows for viewing individual country profiles, including an assessment of strengths and weaknesses and trends.
Also for this edition of the EIS, the measurement framework introduced in 2021 and comprising 32 indicators was applied. The data analysed refer to the five-year period 2017-2024. A subset of 19 indicators was used to compare the EU’s performance with that of eleven global competitors.

The main results for 2024

The overall figure emerging from the European Innovation Scoreboard 2024 shows that overall innovation performance has improved by an average of 10 per cent over the last five years. At the level of individual member states, this trend is in many cases confirmed, albeit at different levels for individual countries (with the sole exception of Luxembourg). The most significant improvements were recorded by Cyprus and Estonia (+39% and +27%, respectively); a large group of countries, on the other hand, grew by less than 5% over the 2017-2024 period (Romania, France, Ireland, Slovakia, Latvia, Bulgaria, Germany, Portugal, Austria, Slovenia).
More specifically, the last year considered (2023-2024) saw an average increase in innovation performance of 0.6% (in line with the previous year), with 15 countries showing a growth trend (> 3% for Lithuania, Poland and Cyprus), while 11 others saw a decline in their performance. Only Croatia remained stable.


The 2024 edition of the report also divided the EU countries into four different innovation groups, based on their scores. The Innovation Leaders comprise the countries with a performance greater than 125% of the EU average (Denmark, Sweden, Finland and the Netherlands). Strong Innovator countries include Belgium, Austria, Ireland, Luxembourg, Germany, Cyprus, Estonia and France (performance between 100% and 125% of the EU average). Italy ranks among the Moderate Innovator countries, together with Slovenia, Spain, Czech Republic, Malta, Lithuania, Portugal, Greece and Hungary (70%-100% of the EU average). Emerging Innovators, finally, have innovation rates below 70% of the average and include Croatia, Poland, Slovakia, Latvia, Bulgaria and Romania.


Among the non-EU neighbouring countries, Switzerland was found to be the most innovative country, due to its attractive research systems, human resources and intellectual property management, and business investment. Globally, South Korea emerged as the most innovative competitor, with a performance exceeding the EU average of 21.1%. Canada, the United States and Australia also outperform the EU, as they did in 2023; finally, China has increased its innovation rate by 28.2% since 2017, catching up with Japan and moving closer to the EU.

New gene mutation with possible role in the development of Parkinson’s disease

Giuliana Miglierini
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New gene mutation with possible role in the development of Parkinson’s disease

The sequencing of the exome (the coding region of the genome) of more than 2,000 patients with familial Parkinson’s disease, and its comparison with data from nearly 70,000 healthy subjects, led to the discovery of a mutation in the RAB32 gene in 0.7% of Parkinson’s disease patients. The international study was coordinated by the University of Massachusetts and also involved researchers from the IRCCS Istituto Auxologico Italiano and the University of Milan. The results have been published in the journal Nature Genetics.

The results obtained during the project help to explain the genetic causes and pathogenetic mechanisms of the disease. Indeed, the research has shown how mutation of the RAB32 gene significantly increases the kinase activity of the LRRK2 protein, whose mutations represent one of the most common genetic forms of Parkinson’s disease. This results in the development of the neurodegeneration typical of this disease.
‘This study represents a significant step forward in the understanding of Parkinson’s disease,’ commented Nicola Ticozzi, director of the U.O. of Neurology at Auxologico and associate professor of Neurology at the University of Milan, co-author of the study. ‘The identification of a new disease-associated gene offers new opportunities for research and treatment. Indeed, knowing that the RAB32 gene is involved in the pathogenesis of the disease will make it possible to explore new biological pathways and potential therapeutic targets.’ From a practical point of view, this discovery could firstly improve the ability to diagnose Parkinson’s disease earlier, especially in familial cases, allowing early intervention. Secondly, a better understanding of the role of the RAB32 and LRRK2 genes in the disease could lead to the development of new targeted drugs that act on these specific pathogenetic mechanisms, thus improving the available treatment options. The resulting improvement in the diagnosis and treatment of Parkinson’s disease could help improve the quality of life of patients and reduce the economic and social burden associated with this disease.

Image source: Canva

Project Capsule, online advertisements of counterfeit drugs are often not recognised

Giuliana Miglierini
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Project Capsule, online advertisements of counterfeit drugs are often not recognised


Despite the fact that the online channel has become an important point of reference for many people to purchase non-prescription drugs, consumers are only able to correctly classify half (53%) of online advertisements related to medicines as licit or illicit. This is the finding of the Project Capsule, conducted by the Transcrime Research Centre of Università Cattolica del Sacro Cuore of Milan with the support of the Office of Product Quality and Countering Pharmaceutical Crime of the Italian Medicines Agency (AIFA) and with the contribution of the Center for Anti-Counterfeiting and Product Protection (A-CAPP) of Michigan State University.

Capsule aimed to investigate, in particular, market dynamics, after the Covid-19 pandemic saw a significant growth in the illicit market for drugs through online advertisements and misleading websites. The key objective, therefore, was to assess the degree of consumer awareness regarding the risk of purchasing substandard and falsified drugs (SFMs) online by examining the exposure and behaviour of Italian and Spanish consumers. The results obtained form the basis for developing targeted information campaigns and specific interventions.

The main results of the project

Conducted in January 2024, the project Capsule involved a representative sample of regular Internet users in Italy and Spain who were aware of the possibility of purchasing medicines online and exposed to online ads or who had purchased at least one medicine online. The trial involved administering a combination of licit and illicit drug ads to consumers. Ads were correctly classified as legitimate in 63% of the cases; greater, however, was the difficulty in identifying illicit ads (43% in Italy and 42% in Spain). The absence of a Ministry of Health certification label, the absence of a drug description or the presence of errors in the description were identified as the factors exerting the greatest influence on consumer evaluations.

Older participants showed less ability to recognise illicit advertisements, while younger participants showed less trust in pharmacists and doctors and a greater propensity to rely on the Internet to search for health information. Behaviour that could be the subject of specific awareness-raising campaigns targeted at demographic and consumer groups.
On the other hand, awareness was good in both Italy and Spain (73% and 66%, respectively) that in the two countries legal online sales of medicines are restricted to non-prescription medicines only. More difficulty was found in the ability of consumers to correctly distinguish between food supplements and medicines, products that are subject to different regulations.

The Internet continues to be a significant channel for finding medical information (58% in Italy, 52% in Spain); around 40% of the sample indicated that they search online for specific medical solutions or alternative treatments. The rate of online purchases of medicines was higher in Italy (69%) than in Spain (52%). The majority of Italians (85%) and Spaniards (75%) stated that they had viewed at least one type of online advertisement for medicines. In Italy, the majority of online purchases concerned medicines for influenza, followed by medicines for chronic pain and cholesterol treatment. In Spain, consumers mainly bought products to increase performance (sports or concentration) and for weight l

The WHO approved the amendments to the International Health Regulations

Giuliana Miglierini
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The WHO approved the amendments to the International Health Regulations

The amendments to the International Health Regulations (IHR) were approved on 1 June 2024 during the World Health Assembly held in Geneva. The approval is the result of two years of intense negotiations. More than 190 countries were involved, among which also all EU Member States. The new text of the IHR aims to improve the management of public health emergencies of international concern and to better protect all citizens from serious cross-border health threats.  This is also a priority of the EU’s Global Health Strategy. 

The legally-binding international rules were first agreed almost 20 years ago. The IHR’s framework has been now updated, as a consequence of the pandemic. The revised IHR will help countries to prevent and respond to acute public health risks and improve the global health security architecture. The European Commission also welcomed the agreement by the World Health Assembly to continue the ongoing negotiations on the Pandemic Agreement, with the goal of reaching consensus by the next World Health Assembly in May 2025. 

EMA’s Annual report 2023

Giuliana Miglierini
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EMA’s Annual report 2023

In 2023, EMA recommended the authorisation of 77 medicines for human use, including 39 with a new active substance, according to EMA’s annual report 2023. Among new treatments are also two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV). EMA also recommended for approval the first advanced therapy medicinal product based on the gene-editing technology CRISPR/Cas9 to treat beta thalassemia and severe sickle cell disease. The Agency also adopted two positive opinions for medicines for use in countries outside the EU.

EMA’s three major strategic areas in 2023 were cancer medicines, data-driven medicine regulation, and transparency and communication. The report is also available in a digital version,  allowing users to filter and interact with the data.

EMA also recommended 14 veterinary medicines for marketing authorisation, nine of which based on a new active substance. Among the new veterinary medicines are also six biotechnological vaccines.

In 2023, EMA also launched the new initiative “Cancer Medicines Pathfinder” to further support the development and approval of cancer medicines which could have a significant impact on patient care.

How to favour access to new antimicrobials

Giuliana Miglierini
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How to favour access to new antimicrobials

A recent report from the Access to Medicine Foundation focuses on five late-stage projects targeting some of the most severe drug-resistant pathogens, with the goal to favour access to newly-developed drugs by single patients who needs them. Late-stage R&D projects across the pipelines of GSK, F2G, Innoviva and Venatorx were monitored (gepotidacin, olorofim, zoliflodacin and cefepime-taniborbactam, respectively) as well as Pfizer’s recently approved aztreonam-avibactam (Emblaveo®). Four of the five companies analysed by the report (GSK, Pfizer, Innoviva and Venatorx) are initiating or conducting clinical trials involving children, a positive signal in moving towards closing the gap between adult and paediatric access. The analysis also included 113 low-and middle-income countries (LMICs). For only 5 (China, India, Mexico, South Africa and Thailand), concrete commitments for registration were identified, while many of the remaining 108 LMICs face high burdens of diseases targeted by the projects and could benefit from access to them. The report identifies opportunities and recommendations for the included companies and suggests actionable steps for peers and other global stakeholders in antimicrobial R&D to promote widespread adoption of advance access and stewardship planning.  

Main outcomes from the 2024 Biomanufacturing Policy Summit

Giuliana Miglierini
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Main outcomes from the 2024 Biomanufacturing Policy Summit

The annual meeting organised by EuropaBio, the European association representing the biotech sector, focused on discussions on the best ways to defragment and accelerate biomanufacturing in the EU, Biomanufacturing policies from other global regions were also addresses. Different policy files are underway at EU level, with an impact on relevant products or processes including biopharmaceuticals, new genomic techniques, detergents, alternative proteins and cell-cultivation .

This Summit report summarises the Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis for biomanufacturing in Europe built on outcomes of the discussions. Among them, according to EuropaBio there is the urgent need to address the question “What does the EU want to be?”. The answer should include considerations on innovation, skills, smart and agile legislation and financial instruments, and the Single Market. The suggestion coming from the report is that the EU would need a smart industrial policy for biotech and biomanufacturing rooted in science-based policymaking, so to incentivises the scale-up of infrastructures and sustainable solutions and  to create innovative and resilient supply-chains.

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