Pharmaceutical incentives in the EU

Produced in partnership with Tine Carmeliet of A&O Shearman , Eveline Van Keymeulen of Latham & Watkins and Jeanne Fabre of Latham & Watkins
Practice notes

Pharmaceutical incentives in the EU

Produced in partnership with Tine Carmeliet of A&O Shearman , Eveline Van Keymeulen of Latham & Watkins and Jeanne Fabre of Latham & Watkins

Practice notes
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What are pharmaceutical incentives?

In the EU, protection mechanisms and incentives for medicinal products, bundled under the term pharmaceutical incentives (PIs), exist.

PIs consist of certain legislative measures which grant originator pharmaceutical companies (originators) a certain benefit compared to companies which sell medicinal products with the same active substance for a much lower price (generic companies)—ranging from market protection (MP) or a prolongation of patent rights to several years of market exclusivity for a medicinal product.

Rationale behind PIs

PIs were introduced in the EU to encourage and support originators in discovering and developing new medicinal products. Whereas innovation and discovery often requires a substantial time and financial investment, a minimum effort is needed to use the knowledge obtained by such discovery afterwards.

Indeed, when a generic company copies an invention, it often does not have to endure the very substantial research and development (R&D) costs of developing such invention and, hence, is able to sell the resulting medicinal

Tine Carmeliet
Tine Carmeliet

Lawyer, A&O Shearman


Tine is a key lawyer within Allen&Overy's life sciences team and splits her time between Paris and Brussels. She was also seconded to the European Federation of Pharmaceutical Industries Associations legal team, where she worked on regulatory and IP policy, including pharmaceutical incentives, Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) and off-label use.
 
Her practice focuses on EU/Belgian regulatory and intellectual property laws and systems, including contentious patent work (such as patent revocation and infringement proceedings on cancer treatment, precision medicine and vaccines), regulatory advice (issues on the entire life cycle of a medicinal product, clinical trials, product approvals, regulatory incentives, early-access programs, MDR and IVDR, real world data and transparency regulations) and transactional issues with respect to the life sciences industry. She also specialises in agro(bio)tech and (EU) food and feed regulations (new breeding techniques; Nagoya Protocol and regulatory requirements for cannabis for medical use).
 
She represents multinational companies and start-ups before the Belgian and European courts, and has worked on several landmark cases.
 
In 2020, she was selected as a trailblazer for WIPR's most influential women in IP. She is an active speaker and writer on IP and life sciences topics and has featured as a speaker on conferences such as the Pharmaceutical Law Academy in Cambridge. She combines her passion for pragmatic solutions with in-depth research through a part-time research mandate at the University of Leuven.

Eveline Van Keymeulen
Eveline Van Keymeulen

Partner, Latham & Watkins


Eveline Van Keymeulen is a partner in Latham & Watkins’ Brussels and Paris offices and a member of the firm’s healthcare and life sciences practice.
 
Ms Van Keymeulen advises multinational companies and start-ups in the pharmaceutical, biotech, medical devices, cosmetics, and food and beverage sectors on a broad variety of complex European, domestic and cross-border regulatory matters, including clinical trials, product approvals, regulatory incentives, market access, promotion and advertising, post-market obligations, and general compliance matters.
 
In addition, Ms Van Keymeulen has extensive experience advising on medical cannabis and hemp-based product regulations. She successfully challenged the legality of French hemp regulations in the first case related to cannabidiol (CBD) products before the Court of Justice of the European Union (Case C-663/18, Kanavape). This landmark judgment had a major impact on the development of the European CBD industry. 
 
Ms Van Keymeulen is ranked in Chambers for Life Sciences Regulatory (since 2020) and recognised as a Legal 500 Rising Star / Next Generation Lawyer in Healthcare and Life Sciences (since 2018). She is considered a National and Global Leader by Who’s Who Legal Life Sciences (since 2016) and is further recognised as one of the leading life sciences practitioners in France by Legal Media Group 2021, Best Lawyers 2021 and Euromoney’s Women in Business Law Expert Guide 2021. Ms Van Keymeulen was also recognised as European Advisory Lawyer of the Year (2021) by, and won Impact Deal of the Year at, the prestigious Europe LMG Life Sciences Awards (2021-2022). Clients particularly value her “high level of energy”, and appreciate her for “being extremely flexible and genuinely engaged” as well as having a “can do attitude” while some have even called her a “rockstar”. 
 
Ms Van Keymeulen has authored numerous articles and has been a featured speaker on EU regulatory matters at prominent conferences such as the Pharmaceutical Law Academy in Cambridge. Ms Van Keymeulen also serves on the editorial board of the European Pharmaceutical Law Review. In addition, Ms Van Keymeulen has been quoted in BBC Business Daily, Bloomberg, The Times, Les Echos and other leading international business journals on life sciences regulatory and policy matters.

Jeanne Fabre
Jeanne Fabre

Associate, Latham & Watkins


Jeanne Fabre is an associate in the Paris office of Latham & Watkins and a member of the firm’s healthcare and life sciences practice. She advises multinational companies and start-ups in the pharmaceutical, biotech, medical devices, cosmetics, and food and beverage sectors on a broad variety of complex European, domestic and cross-border regulatory matters, including clinical trials, product approvals, market access, promotion and advertising, post-market obligations, contracts and general compliance matters.
 
Ms Fabre has significant experience working in pharmaceutical companies. Since her Master’s in Life Sciences Law, she has worked for more than three years for several companies, both for local affiliates and parent companies. She was seconded for 18 months part-time to a pharmaceutical company specialising in rare diseases, and a further three months for another pharmaceutical company. During that time she advised on a wide range of day-today regulatory topics (such as observational, (former) ATU and post-ATU studies, contractual relationships with service providers, consultancy and pay for performance agreements and pricing and reimbursement topics).

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Jurisdiction(s):
United Kingdom
Key definition:
Originator definition
What does Originator mean?

Another term for reference medicinal product, which has been granted a authorisation'>marketing authorisation (MA) on the basis of a complete dossier in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC, and to which the application for MA for a generic medicinal product refers, by demonstration of bioequivalence.

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