All posts by Valeria Ramponi

About Valeria Ramponi

Valeria works at the Firm as trainee, focusing on the drafting of corporate acts and commercial contracts, especially in the field of Life Sciences. Valeria graduated cum Laude from the University of Milan in 2018, focusing her studies mainly in the field of international public and private law and she obtained Diplomas of Higher Education at the Italian Institute of International Political Studies and at The Hague Academy of International Law. Valeria speaks fluent Italian and English.

An Update on the Latest Amendments to the Italian Pharma Industry Association’s Code of Ethics

Legal news, , , ,

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:

  • Training and Information to Non-Prescribers: new section 3.25 (i) allows pharmaceutical companies to carry out training and information activities aimed at healthcare professionals who are not authorized to prescribe medicines, but are involved in the treatment management, provided that such activities do not have any promotional purpose and that the information provided is linked to their roles in patients’ treatment management; and (ii) extends to such professionals the possibility to attend events, courses and congresses, as long as such events do not concern topics relating to medicines;
  • Information to the Public: new section 3.26 (i) allows pharmaceutical companies to provide unsolicited information to the public, through personnel not belonging to commercial or marketing areas, relating to products and diseases pertaining to the relevant therapeutical area, provided that such information does not have a commercial nature and matches the information set forth in the package leaflet or institutional information channels; and (ii) confirms that a full literal reproduction of the package leaflet information may be published on the companies’ websites available to the public;
  • Interactions Other than Medicines Promotion: new section 3.28 (i) allows pharmaceutical companies to provide information on medicines to various stakeholders such as institutions, professionals, organizations, etc., without this falling within the scope of medicines promotion; and (ii) specifically regulates the possibility to carry out, during the medicine’s life cycle, institutional and market access activities or other non-promotional interactions towards institutions and health care professionals, as well as account management activities aimed at ensuring the application of commercial policies through interactions with public or private counterparties involved in the medicines procurement processes and activities aimed at the mutual sharing of non-promotional information and data.

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.

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

Legal news, , , , , ,

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

Agreement Reached on the European Copyright Directive

Legal news, , , , , , , , ,

An agreement has been reached on the much discussed European Directive on copyright. http://europa.eu/rapid/press-release_IP-19-528_en.htm. In a race against time to close the dossier by the end of the legislature, in the late evening of February 13, the Parliament, the Commission and the Council of the European Union have finally found an agreement on the copyright directive, which this blog already illustrated https://lawhealthtech.com/2018/09/24/copyright-european-legislation-getting-ready-for-the-digital-era/ .

The vice president of the European Commission immediately tweeted «Europeans will finally have modern copyright rules fit for digital age!». Supporters insist that the new provision will guarantee rights for users, fair remuneration for creators and clarity of rules for platforms. On the other hand, the opposition, stronger than ever before, wants to prevent the imminent change of the internet as we know it.

The highest expectations, placed on the trilogue, concerned the much debated articles 11 and 13, and these have reported to be the outcomes:

  • With regard to the publishers rights, the new version of article 11 sets forth a general need to get a license for the online use of publishers’ press publications, with the only exception for the use of «individual words or very short extracts». According to the Commission, mere hyperlinks and snippets are, therefore, not included in the reform. However, how short should be a “very short extracts” is still to be understood.
  • With regard to the use of protected content by online content sharing services provider, online platforms should obtain a preemptively authorization from the right holders, concluding licensing agreements (where online platform is defined as «a provider of an information society service whose main or one of the main purposes is to store and give the public access to a large amount of works or other subject-matter uploaded by its users which it organizes and promotes for profit-making purposes»). Indeed, an exception has been created for small online platforms, which will not be subject to the abovementioned obligation if they: have been available to the public for less than three years; have an annual turnover below 10 million of euro; and have less than 5 million of visitors.

In the other cases, if no authorization is granted, sharing services providers shall be liable for unauthorized acts of communication unless they demonstrate not only to have made the best efforts to obtain the authorization, but also, in accordance with high industry standards of professional diligence, to have made the best efforts to ensure the unavailability of specific works, as well as to have acted expeditiously to remove the content, after receipt of a notice from the right holders.

We will see if the agreement will survive until the finishing line or if the vote of the European Parliament, scheduled for March-April, will block the text once again, as, unfortunately, already happened.

Copyright European Legislation: Getting Ready for the Digital Era.

Legal news, , , , , , , , , , ,

On September 12th the European Parliament approved amendments to the controversial Proposal for a Copyright Directive, the “Directive of the European Parliament and of the Council on Copyright in the Digital Single Market”, which aims at updating copyright rules.

Not many topics have polarized opinions in recent years in Europe. While supporters claim to have protected artists and to have inflicted a blow to the American tech giants, critics have talked about the “death of the internet”.

For clarity, even if the Directive passed the European Parliament vote, the changes are not yet definitive and it may be too early to conclude on what this decision entails. The Directive text shall be further reviewed in subsequent negotiations and there is still a slight chance that it may be rejected at another vote by the European Parliament in 2019. In addition, the Directive, even if (and when) definitely approved, should be implemented by single Member States.

But which results does the Directive aim to achieve?

Its scope and purpose appear based on the evolution of digital technologies, which has changed the way copyright works and other protected material are created, produced, distributed and exploited, with the consequence that new uses, new payers and new business models have emerged. The digital environment has given birth to new opportunities for customers to access copyright-protected content. In this new framework, right-holders face difficulties to be remunerated for the online distribution of their works. So, even if the objectives and principles laid down by the EU copyright framework remain valid, there is an undeniable need to adapt them to the new reality.

The Directive also intends to avoid the risk of fragmentation of rules in the internal market. In fact, the Digital Single Market Strategy1 adopted in May 2015 identified the need «to reduce the differences between national copyright regimes and allow for wider online access to works by users across the EU». The idea expressed in the 2015 by the European Commission was to «move towards a modern, more European copyright framework». The EU legislation purports to harmonize exceptions and limitations to copyright and connected rights, however some of these exceptions, which aim at achieving public policy objectives, such as research or education, remain regulated on national level, with the consequence that legal certainty around cross-border uses is not guaranteed.

As to the content of the Directive, we note the following points:

  • With specific regard to the scientific research, recital number 9 of the Directive says that the Union has already provided certain exceptions and limitations (even if optional and not fully adapted to the use of technology in the scientific research) covering uses for scientific research purposes which may apply to acts of text and data mining. Where researcher have lawful access to content, for example through subscription to publication or open access licenses, the term of the licenses may exclude text and data mining.
  • Article 11, called “link tax”, gives publishers a right to ask for paid licenses when online platforms share their stories. The amended version clarifies that this new rights «shall not prevent legitimate private and non-commercial use of press publications by individual users». The amendment tries also to clarify what can be considered as “sharing a story”, indicating that the mere hyperlinks cannot be taxed, nor can individual words.
  • Article 13, called by the critics as “upload filter”, sets forth that platforms storing and giving access to large amounts of works uploaded by their users shall conclude licensing agreements that include liability for copyright infringement, thus putting a large responsibility on platforms and copyright holders that must «cooperate in good faith» to stop this infringement by carefully monitoring every upload.

The Directive has been designed with the intent to rebalance the core problem of contemporary web: big platforms like Facebook and Google are making huge amounts of money providing access to material made by other people. Nevertheless critics object that this intent could lead to serious collateral effects.

We will see what the future of this Directive will be, and which consequences will entail. The path seems to be still long, but, at least, it has started.