We hope you had a lovely summer and your batteries are fully recharged.
Businesses continue to face challenges due to soaring gas prices and supply chain disruptions. Depending on the agreement, there may or may not be a contractual remedy for such imbalances.
Find out what Italian law provides for contracts with private parties and public entities.
Meanwhile you may check out our client alert , which illustrates the new rules for accreditation of medical centers in Italy:
https://www.grplex.com/it/newsletter/download/1057/client-alert-7-2022
authored by our administrative law partner Laura Sommaruga.
Enjoy your holidays (and do not forget that they are crucial for your well being and sustained productivity, as confirmed by the WHO!).
This year, again, Leaders League believes our firm does an excellent job in the life sciences area:
Our great team continues to make this possible: thank you Flavio Monfrini, Francesco Stelio Clerici, Filippo Valle, Giulia Titola and Elisabetta Trecani!
Confused about the Digital Service Act, the Digital Markets Act, the Data Governance Act and the Data Act? My recent article tries to make sense of all of them:
The article also explains that the European Union has a strong vision on principles and policies for the digital age and aspires to a worldwide leadership role in the governance of digital phenomena.
The second issue of our summer series focuses on the recent decision by the Italian Data Protection Authority, which affects all users of the Google Analytics services in Italy, as well as other similar services that entail the transfer of users’ personal data to the United States.
Read our slides to understand what actions are available to you.
On June 6, 2022 the decision of the Italian Anti-Trust Authority sanctioning Leadiant Biosciences was published. The investigation, which started in 2018, was concluded with an administrative sanction of over 3.5 million for abuse of dominant position.
The Italian Anti-Trust Authority held that the price negotiated with the Italian medicine agency (AIFA) was excessive and unfair on the basis of the following elements:
(i) Leadiant is a monopolist on the market and its orphan drug based on chenodeoxycholic acid (CDCA) is life saving;
(ii) Leadiant intentionally pursued a complex strategy aimed at increasing the price of CDCA;
(iii) Through an exclusive supply agreement with the only reliable supplier of CDCA, Leadiant blocked any galenic manufacturing of CDCA by hospitals;
(iv) Leadiant artificially differentiated CDCA from another drug (a cheaper medicine based on the same active substance as CDCA used off label since it had a difference therapeutic indication); and
(v) Leadiant intentionally delayed negotiations with AIFA, which ended up lasting 2.5 years.
The anti-trust investigation concluded that the drug price was (a) disproportionate compared to the aggregate costs incurred and (b) unfair given the nature of the product, the investments in research and development, the risk of registration and its added therapeutic value.
The above decision taken by AIFA is still subject to appeal by Leadiant. At the same time, anti-trust authorities in Belgium and Spain are investigating Leadiant’s conduct, while the Dutch authority has already issued a sanction.
On May 3, 2022 a Proposal for a Regulation on the European Health Data Space has been published. The proposed European Health Data Space draws from the premise that access and sharing of health data within and across Member States is difficult due to the complexity and divergence of rues, structures and processes. The European Health Data Space aims at “harnessing the power of health data for people, patients and innovation” by pushing towards health data science that will transform public health and foster innovation, while empowering individuals to take control of their health data. This proposed legislation is also a product of the Covid-19 pandemic, where the role of up-to-date, reliable and FAIR health data (i.e., data that is based on principles of Findability, Accessibility, Interoperability and Reusability) have been key in responding to the crisis and developing cures and vaccines. The ultimate goal is to build a European Health Union[1] that would strengthen resiliency of health systems and deliver to each Union citizen.
The European Health Data Space Communication supports both primary and secondary use of health data. With regard to primary health data, patients will have their health data available through access points established by Member States, but connected through a cross-border digital infrastructure, will be able to control and share their health data and mandatory requirements on interoperability, security, safety and privacy will apply. Electronic health record systems are subject to mandatory self-certification schemes, which must comply with essential requirements related to interoperability and security. The European Health Data Space promises to “make continuity of care across EU a reality”[2].
Secondary use of data (i.e., health data used for research, innovation and public health) will also be supported by a European framework. Permit to use the data will obtained by health data access bodies, designated by Member States, which will establish how the data will be used and for which purposes (charges may apply), but always requiring closed secure environments, anonymous or pseudonymised data and transparency in their use. The platform HealthData@EU will facilitate cross border studies.
Governance of the European Health Data Space will be up to a new body, named European Health Data Space Board, chaired by the Commission. The Communication does not forget that investments in digitalization are costly and has made available 810 million euros to support the European Health Data Space.
Benefits of the European Health Data Space are expected for citizens, health professionals, researchers, regulators and policy-makers and for the industry.
[1] Bucher, A. (2022) ‘Does Europe need a Health Union?’ Policy Contribution 02/2022, Bruegel
[2] See page 12 of https://ec.europa.eu/health/publications/communication-commission-european-health-data-space-harnessing-power-health-data-people-patients-and_en
If you are working in the field of compliance, you know how grueling the compliance process can be. Rules need to be decided, written, communicated to employees and third parties, who need to be trained on such rules. Then, the company needs to find out if the rules have been breached and sanction those who breached them. This is how law works in general, so the various phases of the process are not surprising. It is also a largely imperfect method, which can become overly complicated in companies where internal rules are pervasive and complex.
Wouldn’t it be wonderful if the whole process could be governed by digital means? And I am not talking about placing all your compliance material in one big digital repository (something obviously useful, but not inherently changing the nature of the process). Imagine a company built on the principle of compliance-by-design, where the behavior of employees is limited by external tools that simply do not allow non-compliant conducts. (For example, if you place digital limits on banking payments, you will not need to convince employees that they cannot exceed certain payment limits, since the digital code would directly enforce such payment thresholds and the only way to circumvent them would be to hacker the banking program.)
Certain Scholars have seen in blockchains an opportunity for compliance programs and organizational models pursuant to legislative decree 231/2001. Under 231 Italian legislation an entity is punished for not having set up sufficient organizational measures to prevent the commission of a certain crime: in theory, a digital prevention system may be an ideal tool to prevent crime commission with the utmost diligence. If you look for automated solutions online, you will find heaps of offers that promise that compliance will be made easy: the RegTech phenomenon is already well established and generating huge revenues.
I am generally a fan of innovative solutions, but I question how much effort is required in translating compliance information into digital rules. As anyone who deals with artificial intelligence may confirm, the process is generally neither quick nor cheap.
I also wonder whether the field of compliance, based on ethical principles, and therefore inherently human centric, can benefit from a full digitalization. Some have warned against the risk of “brutalization of a workplace relations” and worry that digital compliance systems “imitate predictive policing”.
Compliance requires sophisticated human judgment, and 0/1 binary codes are not always appropriate to automate complex decisions on human interactions based on ethical principles.
Amendments to the Italian pharmaceutical industry association’s (Farmindustria) Code of Ethics have been introduced on January 19, 2022 https://www.farmindustria.it/app/uploads/2018/06/2022-GENNAIO-19.pdf.
One of the most important changes concerns section 4.7, which defines Patient Support Programs (PSP) as initiatives implemented by pharmaceutical companies aimed at making available additional services for the direct benefit of patients. Such services are not intended to replace the services of hospitals and other healthcare organizations. For more information on PSP, check out our previous blog post https://lawhealthtech.com/2022/02/07/new-guidelines-on-patient-support-programs-adopted-by-italian-pharma-industry-association/ .
Besides, other important amendments have been introduced:
The above new provisions of the industry Code of Ethics undoubtedly aim at regulating several aspects of the day-to-day promotional and educational activities of pharmaceutical companies that have been so far ignored by the industry association regulations. However, the new previsions are quite vague in their scope and it remains to be seen whether they will have any meaningful impact on the market practices in the pharmaceutical sector.
Law, Health & Technology 
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