Executive Summary
This year's EU Pharmaceutical Law Forum took place as a five-day virtual conference, exploring topics from drug pricing and legal strategies to new changes under the EU MDR and IVDR.
The vibrant agenda delivered live and on-demand sessions, presented by legal and regulatory experts in the pharmaceutical industry.
Medical and regulatory writer Zoya Marinova highlights the key presentations from the week.
Florian Schmidt, Deputy Head of Unit, DG SANTE, European Commission presented the Pharmaceutical strategy for Europe developed by the European Commission (EC).
The Strategy aims to create a future-proof regulatory framework that promotes adaptivity and responsiveness.
It addresses challenges arising with the rapid technology progress and questions related to patient access exacerbated by the COVID-19 crisis.
These issues have already been in the focus of the EC in recent years.
Thus, the European Commissioner for Health and Food Safety Stella Kyriakides received a mandate from the EC President Ursula von der Leyen to help ensure the availability and affordability of medicines while supporting the European pharmaceutical industry as an innovator and world leader.
Furthermore, in her State of the Union speech, the EC President von der Leyen built on the idea that Europe needs not only a Pharmaceutical strategy but also a strong European Health Union.
The key and interconnected pillars of the Pharmaceutical strategy for Europe are: to ensure accessibility and availability of medicines while addressing medicine shortages, to ensure the affordability of medicines for patients while mainlining the sustainability of health systems, to enable sustainable innovation and to achieve success on the global level.
The strategy uses a holistic approach to cover the whole lifecycle of medicines. In addition to legislation, it focuses also on research funding, infrastructure and digitalisation support and capacity building within the regulatory system.
The next topic Schmidt focused on was innovation within the framework of the Pharmaceutical strategy for Europe, including digital transformation, artificial intelligence, big data, real-world evidence, bedside production and innovation funding.
He noted that the revolutionary developments in digitalisation, genomics and innovation may improve patient outcomes but also pose certain challenges.
The EU framework should be kept up to date, the right infrastructure should be created and the expertise of the participants in the medicine lifecycle should be built to advance the EU into a global innovation health hub.
The Pharmaceutical strategy was the subject of a public consultation, and valuable feedback was received from all stakeholders.
Moreover, on 24 November 2020, the strategy was published as a Commission’s communication, laying out its detailed objectives, challenges and key targets.
This triggers the implementation phase of the strategy, including legislative and non-legislative actions, that will be implemented under the mandate of the current EC in cooperation with its key institutional partners and the pharmaceutical industry.
William Long, Partner at Sidley Austin LLP, explored recent tensions in relation to data privacy in the context of clinical trial activities and international data transfer.
He underscored that the ability to function globally and transfer data internationally is of paramount importance for scientific research and reviewed rapid developments in this area, including the publication of important opinions and papers by the European regulators.
In this context, Long presented the Opinion on the interplay between the EU CTR and the EU GDPR by the European Data Protection Board (EDPB) adopted in 2019.
It focuses on the appropriate legal ground for the “primary use” of personal data in the context of clinical trials and the secondary use of clinical trial data for other scientific purposes.
With respect to reliability and safety, one can rely on the legal obligation to carry out those activities within the clinical trial.
Notably, for the purposes of data protection, the EDPB recommended relying on legitimate interest ground and carrying out a legitimate interest assessment.
The EDPB Opinion stated that further processing for scientific research purposes shall not be considered incompatible provided it is subject to appropriate safeguards.
The roles of the different actors within the clinical trial context and how they share data was also reviewed.
Although there are indications that both the sponsor and site can act as data controllers, this is not always the case.
Thus, there is tension and inconsistency on some key issues, such as whether consent is required from a data protection perspective in a clinical trial, and who is responsible as a data controller or processor.
Another area of tension concerns the ability to transfer personal data outside of Europe.
This important question has become especially relevant with the landmark Schrems II case. The judgement of the Court of Justice of the European Union (CJEU) from 16 July 2020 declared the EU-US Privacy Shield immediately invalid.
Standard contractual clauses (SCCs) were considered valid only to the extent that an assessment was carried out.
The Schrems II judgement has led to further developments. Thus, the US has published a white paper, whereas EDPB has released detailed recommendations on the process European companies should follow in assessing the international transfer of data.
In November 2020, the EC published a draft adequacy decision implementing revised SCCs with a 1 year grace period.
Andres Liivak, Partner, White & Case LPP began his presentation by highlighting how the COVID-19 pandemic has accelerated societal trends and changed the industry.
Greater liquidity has entered the economy globally, resulting in historically high asset price multiples.
Moreover, investment is moving toward complex, riskier businesses, including biotech and pharma. There has also been a surge in special purpose acquisition companies.
Thus, the first trend Liivak noted is the strong influx of money into the pharma and biotech sectors.
This means more competition but can also be viewed as an interesting phase of the investment cycle with an attractive set of potential deals.
Next, Liivak focused on digital health, including telemedicine. He highlighted regulatory blockages as a major impediment, especially within the context of telemedicine; however, the pandemic has necessitated changes and opened new opportunities. In deals related to telemedicine, generally two companies with very different core competencies and appreciations for liability and risk come together.
This may lead to difficult negotiations, and the parties have to learn from each other, to ensure a good transactional setting. Another challenge according to Liivak is structuring the relationship in a way ensuring a clear pathway to monetisation.
The affordability of and access to drugs was the next discussed problem. Liivak mentioned special considerations regarding non-profit deals, where the focus is on getting a drug to as many people as possible and at as low a price as possible.
However, there is still a need to appreciate the goals and motivations of one’s counterparty and balance them with one’s own.
The COVID-19 crisis, in Liivak’s opinion, has changed the way deals are made. He believes that, even though teams have adjusted to working asynchronously, tracking, follow-up and resolution may be somewhat delayed.
Another challenge he sees is adapting to the new risks to performance. There is generally a greater government involvement in COVID-related business activities, and dynamic developments have occurred in foreign direct investment, trade and antitrust regulation.
In light of pandemic-related delays, Liivak recommends basing data diligence on factual development achievements. Moreover, supply chain risk has become a first tier issue and a key negotiating point in many deals.
Finally, the risk of bankruptcy, insolvency and restructuring associated with the COVID-19 crisis may impede the launch of new drugs and commercialisation.
