Tag Archives: pharma

Happy GDPR-compliant Xmas and a prosperous new year!

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Winter recess is about to start. While we’ll all be resting, GDPR will not!

While we will all be recharging our batteries to tackle the challenges for the upcoming 2025, GDPR will not go on vacation, and will thus never be out-of-office!

Check out the following tips that the Italian Data Protection Authority has recently issued in order to avoid threats to your privacy rights during the upcoming vacations:

  • Are you receiving plenty of virtual greetings and commercial offers? Be careful about them, even if apparently sent by a friend or parent: they may contain viruses, obscure links or may hide tentative of phishing. Not all presents may be welcome.
  • Have you taken good family pictures that you wish to share on your social network? Don’t forget to ask consent of all depicted individuals. Is your grandpa going to provide his consent as well?
  • Have you filmed your children’s Christmas pageant? Keep it for yourself! You’d need consent from all depicted individuals for publishing (including from their parents in case of minors).
  • Are you wishing to download any specific Christmas-related app on your smartphone? Choose them carefully, check their issuer and the reviews. You may inadvertently be downloading the Grinch’s one!
  • Are you going away for a trip? Don’t share too much information and pictures on your social media about your time off, your house and your vehicles, as it may attract thieves. Only Santa Claus shall be allowed to break in without your consent!
  • Are you connecting with your hotel’s or restaurant’s Wi-Fi? Ask the staff about its security: they may not be protected enough.
  • Have you bought any “smart” presents for your little nephews? Check whether they may collect any personal data from their users. In the affirmative, make sure that they will not harm them in any way possible.

Our own additional tips: rest, enjoy good food, spend time with your loved ones, and get ready for 2025! We wish you happy holidays and a healthy and successful new year.

Gitti and Partners Life Sciences Team

The European Commission Recently Fined Teva: but Why?

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With an order issued on October 31, 2024, the European Commission fined Teva Pharmaceutical Industries (“Teva”) EUR 462.6 million for abusing of dominant position in relation to its drug Copaxone.

This European Commission decision is meant to further set on fire the already lively debate on the limits of patent law and antitrust rules in Europe.

1. Allegations: Abuse of Dominant Position and Patent Strategy

The order fined Teva for abuse of a dominant position. Specifically, two conducts were alleged, namely:

  1. The first relates to the delaying of the market entry of competing generics of Copaxone – a drug containing the active ingredient glatiramer acetate produced by Teva and indicated for the treatment of multiple sclerosis – through the filing of several divisional patents and their subsequent waiver. This approach, referred to by the European Commission as ‘divisional games’, had, in the European Commission’s view, the effect of:
  2. artificially extending the term of patent protection; 
  3. restricting competition even beyond the natural expiry of the original patent.
  • The second claim against Teva concerned the dissemination of false information in breach of competition rules aimed at dissuading consumers and healthcare professionals from adopting such cheaper versions of the drug by:
  • denigrating generic Copaxone products; 
  • casting doubts on their safety and efficacy.

2. Legal Analysis of Breaches: Article 102 of the Treaty on the Functioning of the European Union(“TFEU”)

The Commission’s allegations are mainly based on Article 102 TFEU, which prohibits the abuse of a dominant position within the internal market. A dominant company must avoid practices that (i) restrict, (ii) distort or (iii) prevent competition.

The practice of filing “divisional patents”, carried out by Teva, has been considered as an “exclusionary abuse”, as it prevents the entry of new players in the market through manipulation of the patent system.

This approach, although in line with patent law and the procedures of the major patent offices, including the European Patent Office, has been criticized from the competition point of view. In principle, the divisional patent system should protect distinct innovations and not allow the fragmentation of protection for a single invention to artificially obstruct competition.

In addition, the use of a disinformation campaign constitutes an abusive conduct, as it aims at diminishing the quality of competitors’ products without objective reasons, thus damaging the market and final consumers.

3. The Role of Divisional Patents and the ‘Manipulation’ of the Patent System

A divisional patent is an option under European law that allows patent owners to derive “child” patents from a main patent, thereby protecting more specific aspects of an invention. 

This system derives from one of the fundamental principles of patent law, i.e. that a patent can protect one, and only one, invention. Consequently, during the examination of patent applications, it is sometimes necessary to proceed with the filing of divisional applications when the examiner finds that more than one invention was covered by the original application. 

However, in Teva’s case, the excessive use of this practice was found to be abusive, as it was found to be aimed solely at extending the duration of monopoly protection for Copaxone. This practice, in addition to raising ethical and legal questions, led to the consideration of the need to change the patent system to avoid abuses. In particular, it has been suggested that European regulations on divisional patents may be updated to prevent anti-competitive practices, for instance by introducing stricter criteria for divisional patent granting.

4. Implications of the Teva Case for Competition Law and the Pharmaceutical Sector

The fine imposed on Teva represents a turning point for competition law applied to the pharmaceutical sector, as it further and rather explicitly underlines the need for a balance between patent protection and access to medicines. 

The European Commission, with this measure, wanted to give a strong signal against the strategic use of patents to obstruct access to generic medicines, which represent an affordable and accessible solution for patients, and which may also have a very important impact on Member States’ budgets concerning their healthcare spending.

In a scenario of increasing attention to anti-competitive practices in the health sector, the Commission’s intervention could lead other national and supranational authorities to monitor more strictly pharmaceutical companies’ behaviour in similar situations. Moreover, it may be possible that this case will put pressure on a reform of patent rules in Europe, aimed at limiting opportunities for abuse by dominant companies.

Implementation of the “231” Compliance Model in the Pharma Industry: New Guidelines issued by the Italian Association of Pharmaceutical Companies

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On September 5, 2023, the Italian Association of Pharmaceutical Companies (“Farmindustria” – https://www.farmindustria.it/) has issued guidelines to design an organizational model pursuant to the Legislative Decree 231/2001 in the pharmaceutical sector (“Guidelines”).

In particular, the Guidelines, by taking into account the main peculiarities of the pharma industry, seek to identify the typical activities that are most at risk for the commission of criminal offences, and provide detailed guidance about the main policies and preventive actions that should be carried out by companies in order to prevent their commission.

As expected, the highest risks concern relationships with public officials, which may lead to crimes such as corruption or fraud against the State, with significant advantages for pharma companies.

The Guidelines seek to drive the attention of companies involved in the pharma sector on the risks that are latent in the following areas:

  • Relationships with healthcare professionals (“HCP”) and healthcare organizations (“HCO”): compliance programs should regulate activities of the key account managers and their bonuses, sponsorship of congresses, grants and donations to HCOs, gifts to HCPs, as well as other sponsorship or advertisement activities;
  • Relationships with Public Authorities: many interactions with public officials may entail corruptions risks, such as, e.g., obtainment of Market Authorizations, price reimbursement negotiations with the Italian drug regulatory agency (AIFA – https://www.aifa.gov.it/), management of site visits and inspections, participation and execution of public tenders for the supply of drugs to HCOs;
  • Relationships with private entities: relationships with suppliers providing services in the context of clinical studies, pharmacies, patient advocacy organizations, patients and “expert patients”, or management of patient support programs also need to be regulated.

The Guidelines also offer a complete set of policies and other preventive remedies that may be sufficient to prevent the envisaged criminal risks.

The Guidelines are a useful tool for pharma companies and no similar initiatives have been taken by other associations with regard to different industries and sectors. The Guidelines also constitute a benchmark for best practices that will be difficult to ignore.

Do you need help in designing or updating your company’s “231” compliance model? Do not hesitate to reach out!

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

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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”?

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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

Takeaways from the EU Pharmaceutical Law Forum in Brussels

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I really enjoyed attending and speaking at the EU Pharmaceutical Law Forum in Brussels this week. The event offered a number of insights into the legal challenges faced by the life sciences industry in an ever-evolving regulatory landscape. These are the main takeaways from the conference:

#1: Clearly, the political climate is not favorable to pharma and med-tech companies. A number of measures have been proposed at various levels that would significantly decrease the incentives to innovation that companies currently enjoy. Such proposed measures range from halving the term of protection for orphan drugs exclusivity to compulsory licensing of drug patents, from incentives to drug compounding by pharmacies to mandatory price reductions. The general public and the media continue to have a negative perception of the industry and the regulatory framework appears to be evolving in a restrictive way.

#2: Despite the uniform letter of GDPR throughout the Member States, interpretation of data protection rules continues to be very different throughout Europe. This is especially clear in the field of clinical trials, where there is a patchwork of legal solutions that makes it impossible to multinational corporations to adopt a consistent approach. The recent EDPB opinion on the legal basis for processing of data deriving from clinical trials has further shown that there has been a shift away from consent as the legal basis for the processing, but some countries (like Germany, Italy and Spain, for example) continue to find it hard to accept such a shift.

#3: EU harmonization is expected to occur in the coming years in a number of areas, such as off-label use, artificial intelligence and health technology assessment.

#4: Compliance efforts must be continued, but it is clear that formal compliance is not sufficient to shield a company from risks, especially reputational risks. Even when compliance safeguards are in place, the approach to reputational risks must be perfectionist, as pointed out by Ms. Alice Cabrio, compliance officer at Roche S.p.A.

Enjoy your weekend, and do not forget to celebrate the GDPR’s first birthday!

Another September, Another Spending Review.

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This is almost becoming a tradition for the national healthcare service in Italy. Comes September… and a new spending review hits the pharmaceutical and medical device industry.

On August 4, 2015 a law decree has been approved by lawmakers, which introduces a number of new mechanisms for monitoring and reining in public spending in the healthcare sector. In particular, the new legislation has introduced several measures:

  • Negotiations with current suppliers of the national healthcare service in order to achieve a 5% reduction in current spending for general supplies;
  • Negotiations with current suppliers of medical devices in order to comply with the spending thresholds agreed upon between the central government and regional authorities;
  • Centralized negotiations with pharmaceutical companies in order to decrease the reimbursement price of products currently reimbursed by the national healthcare service.

While measures aimed at cutting spending in connection with general supplies and medical devices have been entrusted in principle to local authorities and healthcare providers, the national pharmaceutical agency (“AIFA”) plays a central role in the envisaged mechanism to achieve savings for pharmaceutical products. In accordance with the provisions of the new decree, AIFA has indeed conducted negotiations throughout the month of September 2015, with the aim of decreasing overall spending. The new legislation provides the grouping of products in several “clusters” that include therapeutically similar products, regardless of their active principles. The lowest price in each cluster is then used as the reference price for direct negotiations between AIFA and manufacturers.

The new measures also provide that, in case of failure to reach an agreement, reimbursement by the national healthcare service may be withdrawn. However, it is also expressly provided that generic products are not admitted to reimbursement until any patents and supplementary protection certificates of branded products are definitely expired, thus providing the industry with assurances in connection with their protected drugs.

The reiterated attempts by public authorities to renegotiate prices with suppliers appear to clash not only with basic contractual principles (“pacta sunt servanda”), but also with fundamental rules of public procurement legislation. As the government (in fact, almost yearly) demands discounts on existing contracts, reliance on such contracts is affected, along with transparency and open competition in public procurement procedures. The truth is that the need to cut public expenditures is increasingly overriding basic tenets of contracts and public procurement law.

Med Tech and Pharma industry associations have voiced their concerns, while suggesting that efficiency and savings may be obtained by the national healthcare service through internal reorganization processes rather than by demanding additional discounts to suppliers. In fact, if we step aside from the conflicting commercial interests of suppliers (who want to maximize their revenues) and purchasers (who need to minimize their costs), we cannot but note that, again, the government appears to use cost cutting tools that focus on quantity rather than quality. On the contrary, we would expect that more emphasis should be given to Health Technology Assessment and innovation. We surely need to spend less money, but also to spend it more wisely.

EMA Issues New Guidelines to Prevent Medication Errors

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On April 14, 2015 the European Medicines Agency (“EMA”) released two drafts of good practice guides aimed at improving the reporting, evaluation and prevention of medication errors. The new guides are addressed to regulatory authorities, as well as the pharmaceutical industry.

Medication errors generally refer to unintended mistakes in the processes of prescribing, dispensing or administering of medicinal products in clinical practice and according to EMA they account for an estimated 18.7 – 56% of all adverse drug events among hospitalized patients.

The first guide released by EMA provides an overview of the main sources and types of medication errors, as well as measures to minimize the risks that such errors are made. The second guide, on the other hand, focuses on suspected adverse reactions caused by medication errors, providing guidance and recommendations on how to record, code, report and assess such errors.

The guidelines from EMA recommend a number of actions to marketing authorization holders, including the periodical reporting of information concerning medication errors. Recommendations to the industry include periodical safety update reports and risk management plans to be adopted for each marketed pharmaceutical product. The overall scope of these reporting obligations is to implement a real-life continuous evaluation of the risks and benefits of all medicines placed on the European market.

The two draft guidelines are now open to comments from all relevant stakeholders: the public consultation procedure will expire on June 14, 2015. The final version of the guidelines is expected to be finally adopted later in 2015.

More information and the new draft guides can be found here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/04/news_detail_002307.jsp&mid=WC0b01ac058004d5c1.