data protection Archives - European Industrial Pharmacists Group (EIPG)

European Council’s conclusions on the European Innovation Agenda and research infrastructures


by Giuliana Miglierini The European socio-economic framework is undergoing a profound transformative moment, as a result of the new vision impressed by the von der Leyen Commission, with its goals in the field of the Digital and Green transitions. The Read more

EMA’s new Quality Innovation Expert Group (QIG)


by Giuliana Miglierini Innovative approaches to the development manufacturing and quality control of medicines are becoming the new paradigm to be faced both from an industrial and regulatory perspective. Not only innovative technologies for delivery, such as mRNA vaccines, many Read more

ICMRA report on best practices against antimicrobial resistance


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 Read more

What happens after IP loss of protection

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by Giuliana Miglierini

What does it happen under a competitiveness perspective once intellectual property (IP) protection for medicinal products expired? And what is the impact of the new entries on generics and biosimilars already in the market?

The role of competitor entry on the market has been analysed in a report by IQVIA.

The document focuses on loss of protection (LOP), thus including in the analysis all products that are free from any form of IP rights (patent protection, SPCs, RDP, market exclusivity/loss of exclusivity, data exclusivity, orphan/paediatric drug exclusivity). According to the report, there are many elements to be considered while assessing the impact of IP rights, among which are regulatory issues, prices policies, competitiveness landscapes. Finally, all the previously mentioned issues are today facing a higher pressure due to the incumbent global situation, characterised a generalised economic crisis especially in Europe. One of the main goals of the EU Commission is to increase the attractiveness of the internal market as a key innovative region for investment in the pharmaceutical sector.

The main trends of the past six years

The IQVIA’s report takes into consideration the group of medicines that have lost protection across the past six years (2016–2021), for a total of 118 molecules; it also analysed the impact of the alignment of the regulatory data protection (RDP) rules in Europe occurred in late 2005, as well as the entry of new countries in the EU occurred in 2004 (Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovakia and Slovenia). EU’s enlargement also included Romania (2007), Bulgaria (2007), and Croatia (2013). Many of the products considered in the analysis were innovative medicines, representing approx. 13% of the total European pharmaceutical expenditure at their peak.

According to IQVIA’s data, the total European pharmaceutical market at list prices valued € 1 trillion in 2016-2021. Over the same period, all protected products counted for 37% of total expenditure on pharmaceuticals (€ 377 billion). Medicinal products that lost protection represented roughly 10% of the total EU market value (€103 billion).

Forms of IP protection

Just more than a half (51%) of products that lost protection in years 2016-2021 were subject to a Supplementary Protection Certificate (SPC), while the RDP mainly refers to older cardiovascular, or combination medicines. Eleven years is the current average length of protection in Europe (-4.2 years; it was 15.2 years for authorisations granted in 1999-2005); the decrease can be attributed to the entry into force of the European centralised system, that diminished the impact of delays to LOP. Market exclusivity also depends on the specific form of IP protection chosen, as it may vary the calculation from different starting dates for IP filing.

IQVIA’s data show that SPC represents 32% of the final form of protection; this sums to 19% of SPC followed by paediatric extension. SPC provides a maximum of 15 years of protection, with an average of 14.4 years. Medicines under regulatory data protection are 31% of total (8 years data exclusivity + 2 years market exclusivity +1 year for a significant new indication), the patented ones 11%. Smaller fractions are covered by orphan drug exclusivity (5%) or orphan drug extension followed by paediatric extension (2%). Considering sales values, the preferred constraining form of protection for small molecules is SPC (93%), followed by RDP (83%); SPC plus paediatric extension occurs in 50% of cases for biologics. Small molecules are also often subject (80%) to patent plus other forms of exclusivity (orphan/paediatric extension). According to IQVIA, the undergoing discussion on the review of the European IP legislation may lead to an alignment of the RDP duration to the US standard (5 years for small molecules, 12 years for biologics).

The impact of the different legislation governing patent litigation in the EU vs the US should also be taken into consideration.

Access and competition

Access of new generic and biosimilar medicines in the European market is a long debated issue, as historically it often proved difficult to determine the precise date of patent expiry and to find an alignment between different countries on this fundamental issue.

According to IQVIA’s report, in the years 2016-2021 the duration of access to major EU markets was 36 days. Competition for small molecules has reduced the cost by approx. 41%, with a volume growth of ~27%; the overall savings for the payer was -8% CAGR for the years 2016-2021. Biologics also increased their volumes year-on-year (23%). Less evident are savings for payers (8% increase in 2016-2021), but many biologics benefit of confidential discounts for hospital supplies.

Competition is very peculiar to the European market landscape, with 92% of molecules having competitors recorded by sales value. A very small niche (2%) of small, low value products proved to be less attractive; the remaining 6% refers to products under development. The biosimilar sector is particularly challenging, as only the largest molecules are attractive from the competition point of view; about 30% of products without a competitor in development are biologics.

Central and Eastern Europe countries are still the preferred ones for early access to competitors, compared to the EU4 markets (Germany, France, Italy, Spain), due to dates for LOP that are in many cases still subject to some variation. On the contrary, EU4 markets account for 89% of sales of available molecules; many countries have no recorded sales for 25% of the available originator molecules.

Data by IQVIA indicates that, at a macro-level, the system has reduced the cost of medicines open to competition by 28%, while the volume of treatment increased 27%. Despite this encouraging trend, treatment paradigms shifting were also observed before LOP.

As for therapeutic areas, RDP protected medicines that underwent LOP were mainly referring to anti-hypertensive (73%) and combination products (61%). The higher proportion of SPC protected products was found in systemic anti-fungals (60%), oncology medicines and HIV/anti-virals (45% each). Immunology and lipid regulators are often protected using SPC plus paediatric extension (60% and 50%, respectively)

The importance of intellectual property rights

Estimates of investments in pharmaceutical R&D are approx. €39 billion/year, according to the report. Return on investment relies heavily on IP rights, a theme that is central also to the ongoing review of the EU’s pharmaceutical and IP legislations. Many new treatments are on their way towards approval, especially in the field of advanced therapies; according to IQVIA, more than 60% are first-in-class therapeutics.

Two core concepts support the current European framework for intellectual property rights: a period of exclusivity applying to new compounds (patent protection + SPC), followed by open competition once all IP expired. At this stage, competitors can access open data and manufacturing formulations. Prices are often regulated at the national level to incentivise competition and to positively impact on treatment opportunities available to patients.

The current fragility of supply chains for pharmaceutical productions may pose many challenges to originator companies which remain the sole provider of a medicine after loss of protection. A risk highlighted by IQVIA’s report is a too pronounced decrease of prices to support competition, and thus the sustainability of the market.

Access to innovative medicines is another challenge identified, referring to countries where the originator did not launch its product, and neither the competitors did. Furthermore, competitor entry often refers to low-value medicines. This despite future loss of protection for the years 2026-2030 should refer mainly (55%) to biologic molecules, compared to 43% for the period 2021-2025.



A new role for EMA and a pilot project for the repurposing of medicines

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by Giuliana Miglierini

A draft agreement was reached at the end of October between the Council of the European Union and the European Parliament to reinforce the mandate of the European Medicines Agency (EMA) with reference to crisis preparedness and management for medicinal products and medical devices. “EU-level preparation and coordination are two essential ingredients to fight future health crises. Thanks to this deal we are adding an essential new building block to upgrade the EU’s health architecture. It will allow the EU’s Medicines Agency to make sure we have the medicines needed to deal with public health emergencies”, said Janez Poklukar, the Slovenian minister for health.

The revision of EMA mandate is part of the broader activities announced by the EU Commission in November 2020 to achieve the European Health Union; these also include the reinforcement of the European Centre for Disease Prevention and Control and a draft law on cross-border health threats. The establishment of the new Health Emergency Preparedness and Response Authority (HERA), announced in September 2021, is also part of the package. The draft agreement shall now be endorsed both by the Council and the Parliament before entering into force.

Three new key targets for EMA

The draft agreement reached by the Council and Parliament negotiators focuses on three main areas. The first one refers to the definition of a major event and how to recognise it: these shall be events likely to pose a serious risk to public health in relation to medicinal products, as acknowledged by a positive opinion from the Medicines Shortages Steering Group, and which may trigger specific actions such as the adoption of a list of critical medicinal products to fight the health threat.

Solid funding from the Union budget shall be also provided to EMA in order to support the work of the new steering groups, task force, working parties and expert panels. The availability of provisions for adequate data protection is important to guarantee the full compliance to the GDPR regulation and other EU data protection rules, and the safe transfer of personal data relevant to EMA’s activities (e.g. data from clinical trials).

EMA shall play an improved role in the monitoring and management of shortages of medicines and medical devices, a critical activity for the availability of the products needed during public health emergencies. Other points of the agreement include the timely development of high-quality, safe and efficacious medicinal products, and the creation of a new EMA’s structure specific for expert panels in charge of the assessment of high-risk medical devices and of essential advice on crisis preparedness and management.

How to tackle shortages of medicines

According to the EU Parliament, two “shortages steering groups” (for medicines and medical devices, respectively) shall be created by EMA; if needed, these groups may also include expert advice from relevant stakeholders (e.g. patients and medical professionals, marketing authorization holders, wholesale distributors, etc.).

Parliament negotiators highlighted the importance to achieve a high transparency of the process, including avoidance of interests related to industry sectors for members of the two groups; summaries of the proceedings and recommendations shall be also made publicly available.

A European Shortages Monitoring Platform shall be created by EMA to facilitate the collection of information on shortages, supply and demand of medicinal products; a public webpage with information on shortages of critical medicines and medical devices shall be also made available.

As already occurred during the Covid pandemic, future public health emergencies may boost the development of new medicines and medical devices. Sponsors of clinical trials conducted during health emergencies will be required to make the study protocol publicly available in the EU clinical trials register at the start of the trial, as well as a summary of the results. Following the granting of the marketing authorisation, EMA will also publish product information with details of the conditions of use and clinical data received (e.g. anonymised personal data and no commercially confidential information).

With this agreement, Parliament makes both the Agency and all actors in the supply chain more transparent, involving them more in the process and fostering synergies between EU agencies. Moreover, we pave the way to promoting clinical trials for the development of vaccines and treatments, boosting transparency on those issues. In short, more transparency, more participation, more coordination, more effective monitoring and more prevention”, said Rapporteur Nicolás González Casares (S&D, ES).

EMA’s pilot project for the repurposing of medicines

The repurposing of already approved and marketed medicines is another key action put in place to ensure improved response capacity in case of future health emergencies.

A new pilot project to support the repurposing of off-patent medicines has been launched by EMA and the Heads of Medicines Agencies (HMA), with special focus on not-for-profit organisations and the academia as the main actors to carry out research activities needed to support the regulatory submission for the new indication. The initiative follows the outcomes reached by the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP).

Interested sponsors may access EMA’s specific scientific advice upon submission of the drug repurposing submission form to the e-mail address [email protected] by 28 February 2022. More information is available in a Question-and-Answer document. The pilot will last until scientific advice for the selected repurposing candidate projects; filing of an application by a pharmaceutical company for the new indication is another target. Final results of the project will be published by EMA.

Comments from the industry

The European Federation of Pharmaceutical Industry Associations (EFPIA) welcomed the proposed framework for the repurposing of authorised medicines. “This pilot launch comes at a timely moment to test whether a streamlined and more transparent regulatory pathway for repurposing of off-patent established products increases the chances of including existing scientific evidence into regulatory assessment. One of the goals of the pilot is to raise awareness regarding the standards required for regulatory-ready evidence on the road to further increase availability of authorised therapeutic use”, said the chair of EFPIA’s Regulatory Strategy Committee Alan Morrison.

Innovation on existing, well-known molecules through repurposing can deliver huge benefits for patients, according to Medicines for Europe. The Association of the generic and biosimilar industry supports the pilot project as a way to generate robust data packages and to translate research into access for patients. A sustainable innovation ecosystem for off-patent medicine is the expected final outcome, possibly including also reformulation of existing medicines, new strengths or adaptation for specific patient groups (i.e. paediatric populations). “These investments must also be recognised in pricing and reimbursement policies to make access a reality for all patients”, writes Medicines for Europe.