Monthly Archives: January 2022

Re-Use of Research Data

January 31, 2022Legal newsData Governance Act, open data, PSI, re-use of public sector information, research data, reusePaola Sangiovanni

It may now be easier for private companies to re-use research data generated by the public sector. Thanks to Italian legislative decree no. 200 of 2021 implementing Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information, re-use of research data – whether for commercial or non-commercial purposes – may be carried out so long as intellectual property rights and privacy rights are respected.

In other words, if research data is anonymized and does not include intellectual property, free re-use is possible whenever such research data is generated from public funding and made available by researchers or research institutions through public data bases. Research data must comply with Findability, Accessibility, Interoperability, Reusability (FAIR) principles.

What is “research data”? Research data means “documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results”.

Are you in need of an example? “Research data includes statistics, results of experiments, measurements, observations resulting from fieldwork, survey results, interview recordings and images. It also includes meta-data, specifications and other digital objects. Research data is different from scientific articles reporting and commenting on findings resulting from their scientific research” (whereas no. 27 of the 2019/1024 Directive).

Certain scholars have pointed out how the principle of scientific open data is framed in terms that are too restrictive and continue to clash with intellectual property rights, database and algorithm protection.

While the push for reuse of research data may appear timid at this point in time, the EU seems in any case determined to continue its open data agenda through the Data Governance Act.

Only 1 Week until Go Live of EU-Wide Clinical Trials Information System

January 24, 2022Legal newsclinical trials regulation, CTISPaola Sangiovanni

Remember the Clinical Trials Regulation? Much time has passed since its publication in 2014. No worries if your memory fails you: we have discussed the Clinical Trial Regulation at length in this article appeared on the Indian Law Journal of Law and Technology. If you prefer a shorter summary, you may read here what the European Medicines Agency has prepared for you.

The actual entry into force of the Clinical Trials Regulation depended on confirmation of full functionality of the Clinical Trials Information System (CTIS) through an independent audit, which occurred on April 21, 2021. Now, the go-live date for the CTIS will be on January 31, 2022. Information on the go live planning can be found here.

The Clinical Trials Regulation was born to address the prior directive’s shortcomings, and particularly to target the goals of harmonization and simplification in this field, also with a view of making Europe a competitive region in the global clinical trials market. Good luck to the CTIS: we hope the Clinical Trials Regulation keeps its promises!

Can the Medical Device and Pharma Italian Sectors Be “Influenced”?

January 14, 2022Legal newsinfuencer, marketing, medical device, medical devices, pharma, pharmaceutical, socialnetworkValeria Ramponi

Influencers are everywhere these days. Are they allowed to influence patients and doctors in the healthcare sector?

Pharmaceuticals. With regard to pharmaceutical products, the answer appears to be no. In fact, according to section 117 of Legislative Decree No. 219/2006, advertising of medicinal products must not include recommendations from scientists, healthcare professionals or persons widely known to the public.

A minor and partial derogation was allowed by the administrative court of the Lazio Region, which stated that the sole presence of a well-known person, who does not show any preference for a certain medicine nor gives advice, in an advertising message, does not per se trigger the violation of the legislative prohibition.

Medical Devices. A different conclusion can be reached in connection with medical devices.

In fact, the guidelines issued in connection with advertising of medical devices, expressly allow the use of testimonials, provided that (i) the advertisement is authorized by the Italian Ministry of Health, and (ii) the influencer does not express any advice or recommendation, also implicitly, in connection with the device itself.

But what about an influencer, who shares details of a health treatment by posting photos or videos? Is that advertising or freedom of expression?

The IAP (Institution of Advertising Self-Discipline) is starting to reflect upon the borders between advertising messages and private user’s content. A case-by-case analysis should be carried out, taking into account the context, the form of the presentation and the absence of commercial elements, such as trademarks.

Our conclusion. While our entire life seems to be easily influenced, the Italian legislation and case law is committed to shield us from such influence, at least in connection with our health.

Valeria Ramponi / Giulia Titola