Highlights

28 Agosto

The Italian Ministry of Health promoted a public consultation (from 17 August to 17 September 2023) with the aim of collecting comments on the draft decree and technical regulations indicated by art. 5 Law 62/2022 (so-called Sunshine Act), with regard to the electronic public register (called "Sanità Trasparente").

In particular, the Ministry specifies that the two documents were prepared by an interinstitutional working Group and that:

- the draft decree governs the type of data collected, the transmission and publication of the same, the reports of conduct in violation of the law, as well as the times for publication and storage of data;

- the technical regulations defines the subjects required to transmit data to the Ministry of Health, as well as the authentication and authorization processes of the same, the data to be transmitted, the procedures for consulting the electronic public register, as well as the infrastructural characteristics of the same.

Consultation of the decree and the related technical  regulations allows anyone to provide their own contribution on the proposed topics. The Ministry invites, in particular, to take part in the public consultation the subjects directly involved by the legislation, namely:

  • manufacturing companies operating in the human and veterinary health sector;
  • subjects operating in the health sector;
  • health organizations

From the link https://partecipa.gov.it/processes/sanitatrasparente it is possible to download the questionnaire for the consultation (to complete it, it is necessary to register with your SPID account). As indicated by the Ministry, the data collected will be treated anonymously and the results of the consultation will be made public on 8 October 2023.

22 Maggio

HEALTHCARE

Il Sole 24 Ore - Law Firms of 2023

22/05/2023

Also this year, Astolfi e Associati Studio Legale is among the best law firms in Life Science and Healthcare sector, according to a research conducted for Sole 24 Ore by the company Statista, based on the recommendation of solicitors, company lawyers and clients.
The list of the best law firms of 2023 is available at the Sole 24 Ore website: https://lab24.ilsole24ore.com/studi-legali/?refresh_ce=1 

24 Marzo

Reg. (EU) 2023/607, amending Reg. (EU) 2017/745 and 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, has been published in the Official Journal of the EU.

In order to address the risk of shortages of medical devices in the EU due to the difficulty encountered by a large number of manufacturers (in particular, small and medium-sized enterprises) in demonstrating compliance with the requirements of the new Regulations, the European Parliament and the Council deemed it necessary to further extend the transitional period by which certain devices that continue to comply with Directive 90/385/EEC or Directive 93/42/EEC can lawfully be placed on the market.

In particular, under the specific conditions identified in Reg. (EU) 2023/607, certificates issued by notified bodies from 25 May 2017 that were still valid on 26 May 2021 and that have not been withdrawn afterwards and certificates issued by notified bodies from 25 May 2017 that were still valid on 26 May 2021 and that have expired before 20 March 2023 remain valid after the expiry of the deadline indicated on the certificate until 31 December 2027 (for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors), or until 31 December 2028 (for all other class IIb devices, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function).

Furthermore, devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to Reg. (EU) 2017/745 requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.

With reference to in vitro diagnostic medical devices, Reg. (EU) 2023/607 amends Reg. (EU) 2017/746 by providing that devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022, and devices lawfully placed on the market from 26 May 2022 pursuant to Art. 110, para. 3, Reg. (EU) 2017/746 may continue to be made available on the market or put into service.

Reg. (EU) 2023/607 entered into force on 21 March 2023, the day of its publication in the EU Official Journal.

21 Febbraio

Cosmetics Europe, the European association of cosmetics companies, has launched 'Cosmile Europe', the database collecting information on almost 30,000 ingredients used in cosmetic products.

The database is part of the Cosmetics Europe Transparency Initiative and aims to provide European consumers with easy access to reliable, verifiable and scientifically supported information on the properties and functions of cosmetic product ingredients, as well as their natural or synthetic origin.

The information in the Cosmile Europe database can be searched either by the common name or the INCI name (International Nomenclature Cosmetic Ingredient) of the ingredient, or by substance group or product type.

Cosmile Europe is available in 14 languages and has been developed in partnership with the German Cosmetic, Toiletry, Perfumery and Detergent Association (Industrieverband Koerperpflege-und Waschmittel e. V.-IKW), in collaboration with the French Fédération des Entreprises de la Beauté (FEBEA) and with the technology development support of health&media GmbH, as well as with the involvement of eighteen Cosmetics Europe national association members (the database can be found at https://cosmileeurope.eu/).

01 Settembre

The Medical Device Coordination Group ('MDCG'), a body established under Article 103 of Reg. 745/2017, which provides advice and develops guidance in the medical device sector, has approved the Guidelines for the assessment of notified bodies (MDCG 2022-13 Designation, reassessment and notification of conformity assessment bodies and notified bodies - August 2022).

The document provides guidance to National Authorities responsible for Notified Bodies (in Italy, the Ministry of Health) and to Joint Assessment Teams ('JATs', consisting of representatives of the EU Commission and national experts) in carrying out the assessment processes of Conformity Assessment Bodies ('CABs') seeking designation as Notified Bodies ('NBs') in the medical device sector, and the reassessment processes of NBs.

The aim of the Guidelines is to align and make consistent with each other the working practices of the National Authorities regarding the evaluation, designation, notification and re-evaluation of CABs and NBs, in accordance with the provisions of the European Medical Device Regulations (Reg. 745/2017, "MDR" and Reg. 746/2017, "IVDR").

In particular, the different steps foreseen for the CAB assessment and NB reassessment processes are outlined, identifying the documentation to be submitted, the timelines to be met, as well as the authorities involved and their tasks.

At the end of the document, two flowcharts are made available that provide, for each procedure, a useful summary on the steps to be followed and an estimated duration for each step (the Guidelines are available at the following link: https://health.ec.europa.eu/latest-updates/mdcg-2022-13-designation-re-assessment-and-notification-conformity-assessment-bodies-and-notified-2022-08-10_en).

14 Giugno

Law no. 62 of 31st May 2022, containing “Provisions on the transparency of relations between manufacturing companies, subjects operating in the healthcare sector and health organizations” (so-called “Sunshine Act”) was published in the Official Journal no. 135 of 11th June 2022.

With reference to the contents of the new law, please see the Highlight published on 25th May 2022 (https://www.studiolegaleastolfi.it/in-primo-piano/en_695_sunshine-act-the-text-of-the-draft-law-has-been-approved-by-the-italian-parliament).

Sunshine Act will come into force on 26th June 2022, but for its application it’s necessary to take into account the transitional period outlined by the law.

First of all, it will be necessary to wait for the notice published in the Official Journal on the starting date of the operation of the public electronic register called “Sanità Trasparente” (on which company communications will be published for transparency purposes), which must be set up within 6 months from the entry into force of the law.

Furthermore, according to art. 9 of the new law:

(i) as from the second six-month period following the one in progress on the date of publication in the Official Journal of the communication of the starting date of the operation of the “Sanità Trasparente” Register;

(ii) the disclosure obligations of shareholdings (Article 4) shall apply as from the second year following the six-month period in progress on the date of publication in the Official Journal of the communication of the starting date of the operation of the “Sanità Trasparente” Register.

It is therefore necessary now to wait for the implementation of the Register and then begin the countdown to the application of the law.

25 Maggio

After a long journey that began in 2018, yesterday, the Italian Parliament gave its final approval to the draft law on 'Provisions on the transparency of relations between manufacturing companies, healthcare professionals and healthcare organisations', the so-called 'Sunshine Act'. The text has now to be promulgated by the President of the Republic, before being published in the Official Journal.

 The entry into force of the law will be followed by a transitional period, so that those involved can prepare to fulfil their obligations under the law.

 Here are the main contents of the Sunshine Act.

 Aims pursued and actors involved

The Sunshine Act is aimed at guaranteeing the right to knowledge of relationships of economic importance or advantage, existing between, on the one hand, the so-called manufacturing companies, i.e. the subjects, including those belonging to the Third Sector, that carry out an activity directed to the production or marketing of medicinal products, instruments, equipment, goods and services, including non-health products and  nutritional products, marketable in the field of human and veterinary health, or to the organisation of conferences and congresses concerning such objects, and, on the other hand, the subjects operating in the health sector and health organisations, including any public or even private legal person that provides health services, as defined by Article 2 of the law (Article 1).

 Subject of communications: grants, conventions and agreements

They will be subject to communication:

 1) conventions and payments in cash, goods, services or other benefits made by a manufacturing company in favour of a subject operating in the health sector (if they have a unit value of more than EUR 100 or a total annual value of more than EUR 1,000) or a health organisation (if they have a unit value of more than EUR 1,000 or a total annual value of more than EUR 2,500), and

 2) agreements between manufacturing companies and organisations that produce direct or indirect benefits, consisting in participation in conferences, training events, committees, advisory bodies or scientific committees or in the establishment of consultancy, teaching or research relationships.

 The communication must be made within the six-month period following that in which the disbursements were made and/or the agreements and conventions were entered into and, if the manufacturing company is based abroad, the fulfilment may be carried out by its representative in Italy (Art. 3).

 Subject of disclosures: shares, bonds and incomes from industrial and intellectual property rights

There is also an obligation for manufacturing companies to report, by 31th January of each year, the data of subjects operating in the health sector and health organisations that

 1) are holders of shares in the company's capital or of bonds issued by the company, registered for the previous year in the register of shareholders or in the bond register, or who

 2) have received royalties from the company in the previous year for the granting of licences for the economic use of industrial or intellectual property rights (Art. 4).

 Telematic public register

Within six months following the date of entry into force of the Sunshine Act, a public electronic register called 'Transparent Healthcare' must be set up, in which the aforementioned notifications will be published, as well as the acts imposing the sanctions provided for by the law (Art. 5, paras. 1 and 2).

The electronic public register will be freely accessible by anyone for consultation and will be equipped with functions allowing the search and extraction of the data communicated by the manufacturers (Art. 5, para. 3).

Notifications will have to be submitted electronically in accordance with the instructions that will be determined by the Ministry of Health within three months following the date of entry into force of the law (Art. 5, para. 7).

 “Right to be forgotten”

Notifications published in the electronic public register will be available for consultation for a period of five years following the date of publication, after which they will be deleted (Art. 5, para. 4).

 Consent to publication and rights of the data subject

Consent to the publication and processing of data is considered to be given when the relationship from which the obligation of transparency derives is established. Manufacturing companies will in any case be required to provide appropriate information, specifying that the communications required by law will be published on the institutional website of the Ministry of Health. The law is in any case without prejudice to the rights of data subjects provided for in Articles 15, 16, 17, 18, 19 and 21 Reg. (EU) 2016/679, i.e. the right of access, the right to rectification and the right to erasure of subject's personal data, as well as the right to restriction of processing and the right to object to processing (Art. 5, para. 6).

 Sanctions

Administrative pecuniary sanctions shall be applied in the cases of failure to communicate, communication of incomplete information and communication of false information against manufacturing companies as the parties responsible for the truthfulness of the data contained in the communications (these sanctions will be reduced by half for companies with an annual turnover of less than one million euro provided that they are not controlled by, connected to or bound by supply or subcontracting relationships with other manufacturing companies).

The Ministry of Health is responsible for supervising the implementation of the law and enforcing sanctions (Art. 6).

 Transitional period

The reporting obligations set forth in Article 3 shall apply as from the second six-month period following the six-month period in progress on the date of publication in the Official Journal of the notice in which the Ministry of Health shall communicate the date of commencement of operation of the online public register, while the reporting obligations set forth in Article 4 shall apply as from the second year following the six-month period in progress on the date of publication in the Official Journal of the same notice

24 Maggio

The guideline “MDCG 2022 - 5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices” of the Medical Device Coordination Group (MDCG) has recently been published, in order to provide support in the correct classification of borderline products, i.e. products that are not immediately ascribable to a specific sector due to their nature, for which it is not easy to identify its applicable legislation.

The first part of the document provides the definitions used (a diagram is also provided to facilitate product evaluation, and to establish whether or not it falls within the definition of a medical device), as well as general rules to be applied to identify the nature of a product. Concrete examples are then provided of medical devices (specifying that if a solution contains a medicinal product as a main ingredient, the product will be considered a medicinal product; conversely, solutions incorporating medicinal substances with an auxiliary action, such as preservatives, these substances are classified as medical devices), of medical device accessories (e.g., products to treat contact lenses), as well as medicinal products (e.g., disinfectants to be used on the non-intact skin of the patient before surgery, gases to be used in anaesthesia and inhalation therapy, etc.).

The second part of the Guideline contains separate chapters on specific product categories, such as:

- herbal products (which are usually medicinal products, but it is not excluded that they may qualify as medical devices if the action of its herbal component is only ancillary, and the main action is obtained by physical or mechanical means);

- substance-based medical devices (i.e. medical devices that are composed of substances permitted for this type of product, whose main action is not by pharmacological, metabolic or immunological means);

- medical device and medicinal product combination (in order to identify the correct regulatory reference framework, the first step is to establish whether the product is an "integral" product within the meaning of Regulation 745/2017, and then to understand whether the action of the medicinal product incorporated into the device is principal or ancillary to the function performed by the medical device itself. If the main action of the integral product is carried out by the medical device, the entire product will be considered as a device, and thus be governed by Regulation 745/2017).  

In addition to providing the relevant definitions and referencing the relevant regulatory provisions, numerous examples are given as further support for the purposes of correct classification for each product category.

The document may be subject to modifications by the MDCG in order to reflect scientific and technical developments, as well as the results of regulatory discussions held by the working group.

24 Febbraio

The decree of 30 November 2021 of the Italian Ministry of Health concerning “Measures intended to facilitate and support the conduct of non-profit clinical trials of medicines and observational studies and to govern the sale of non-profit trial data and results for registration purposes, pursuant to art. 1.1.c), of legislative decree no. 52 of 14 May 2019”, which abrogates the ministerial decree of 17 December 2004 and will come into force on 6 March, has been published in Italy’s Official Journal no. 42 of 19 February 2022.

The decree applies, pursuant to article 1, to non-profit clinical trials, to low-intervention clinical trials and to observational studies. It recalls the article 2.2 of Regulation (EU) no. 536/2014 which came into force on 31 January 2022, for the relative definitions, and also sets out the requirements relating to non-profit clinical trials.

The decree envisages the sale of non-profit trial data and results, both during and after completion of trials, for registration purposes, specifying that, after the sale, the specific provisions and special terms envisaged for the non-profit trials will no longer be applicable.

Sales shall be regulated by a contract between the sponsor and the assignee that establishes the agreed amount for the purchase of the data and the results, which is to be set with the assistance of a registered patent attorney.

In the event of a sale, the sponsor of the trial or the assignee is required to (i) cover and reimburse all direct and indirect expenses associated with the trial, (ii) pay the fees due to AIFA (the Italian medicines agency) and the relevant ethics committees, and (iii) allocate a fair valuation of the sale that has taken place to support the non-profit trials.

Furthermore, the sponsor shall transmit to AIFA, to the relevant ethics committee and to the trial centres involved an official notice informing them that the sale of the data and/or results of the non-profit trials has taken place.

Art. 3 also establishes that in case a non-profit trial is requalified as a for-profit trial by its sponsor, the sponsor is required to cover and reimburse all direct and indirect expenses associated with the trial, to pay the fees due to AIFA and the relevant ethics committees and to reimburse funding received for the trial until that time.

Finally, the decree sets out additional provisions envisaging special terms for non-profit clinical trials (art. 2), the application of the provisions as per art. 72 Reg. (EU) 536/2014 regarding co-sponsorship also for non-profit trials and low-intervention clinical trials (art. 4) and the adoption by AIFA of the new guidelines for the classification and conduct of observational studies on pharmaceuticals (art. 6).

13 Gennaio

In its non-definitive judgement no. 8634 of 27 December 2021, the Council of State referred to the Plenary Session of the Council of State the decision whether or not a company owning a pharmacy which is, in turn, owned in full by another company concerned with medical care represents an instance of incompatibility under art. 7, paragraph 2 of Law no. 362/1991, according to which ownership of shares in companies owning a pharmacy “is incompatible with any other business in the field of production of pharmaceuticals, providing of scientific information on pharmaceuticals, or the exercise of the medical profession”. After recalling that the incompatibility preventing pharmacy owners from conducting medical activities, as “motivated by the conflict of interest that results from simultaneously ‘prescribing’ and ‘dispensing’ medications”, “aims to safeguard the public interest in proper performance of the pharmaceutical service and, in the final analysis, the primary interest in protection of the public health”, the Administrative Courts noted the existence of two instances in the presence of which the circumstance of incompatibility may be considered to extend to pharmacies owned by subsidiary companies, and that is, if the parent company may be said to be: a) involved in the “operation” of the pharmacy, and b) exercising the “medical profession”. With reference to the first of these circumstances, the decision under examination considered it necessary for the Plenary Session to intervene, as it was necessary to establish whether the presumption of direction and coordination of the company owning the pharmacy, attributable to the parent company under articles 2359 and 2947 sexies of the civil code, may be considered sufficient to make the latter effectively or actively “involved in the operation of the pharmacy”. As for the second case, the Council of State took the view that it must be taken into consideration that a care home is not a company of medical professionals, as it simply organises and operates care homes, availing itself of the work of physicians, who work as independent professionals and do not entrust their decisions and responsibilities to others, and the circumstance that the physicians present in the shareholding structure of the care home hold positions (as partner or member of the board) entirely separate from their medical work, not allowing them to transfer to the company the distinctive features of their profession. In addition, we must remember that the regulations dictated by Law no. 362/1991 extend the condition of incompatibility only to partners in the company owning the pharmacy, not to the partners or directors of the company owning shares in the company that owns the pharmacy. The consequences that may result from a more or less extensive interpretation of the condition of incompatibility and the general relevance of the case at hand have therefore led the Council of State to put the decision before the Plenary Session in order to avoid the risk of possibly conflicting decisions.

01 Dicembre

The Italian Ministry of Health’s Directorate General for medical devices and the pharmaceutical service has issued a circular setting out indications regarding the application of the new Regulation EU 2017/745 on medical devices (which came into force from 26 May 2021), pending legislative measures for the necessary harmonisation of national and community provisions.

Specifically, the circular clarifies that the provisions of Art. 21 of Legislative Decree 46/1997 regarding the advertising of medical devices continue to apply, since they are compatible with Art. 7 Reg. 2017/745 and, consequently, that the requirements relating to the authorisation of advertising, introduced by ministerial decree 23 February 2006 and by Art. 118 of Legislative Decree 219/2006 (Pharmaceuticals Code), are still valid.

Furthermore, considering that it is the responsibility of the Member States to establish the sanctions to be applied in the event of breaches of the Regulation, pending the introduction of such sanctions, the sanctions envisaged by Art. 23 of Legislative Decree 46/1997 and by Art. 10 of Legislative Decree 507/1992 (e.g., for breaches of the laws governing post-marketing surveillance laws and reporting of accidents, confidentiality, affixing of the CE marking, registration of manufacturers of custom-made devices) remain in effect, with the proviso that sanctions relating to obligations or cases no longer contemplated by Reg. 2017/745 are not to be considered effective.

 The circular also specifies that until the European Databank on Medical Devices (Eudamed) becomes fully operational, the national provisions governing the transmission of information via the new healthcare information system (NSIS) shall continue to apply.

Moreover, the fees currently envisaged by ministerial decree 16 January 2019, by ministerial decree 14 July 2004 and by Ministry of Health circular 25 May 2021 (relating, respectively, to the issue of certificates of free sale and licenses for public advertising, as well as assessment of applications for the authorisation of clinical surveys) continue to be valid, until the fees to be applied for execution of the activities envisaged by Reg. EU 2017/745, in compliance with Art. 111 of the Regulation, have been set.

Additional indications in the circular relate to the products without an intended medical purpose listed in Annex XVI of Reg. 2017/745, recourse to harmonised standards pursuant to Art. 8 Reg. 2017/745 (which establishes that medical devices in conformity with the relevant harmonised standards, whose references have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of the Regulation covered by those standards), notified bodies, legacy devices as at Art. 120, par. 3, Reg. 2017/745, as well as manufacturers of custom-made devices (the circular of 12 November 2021 is available on the website of the Ministry of Health www.salute.gov.it). 

29 Novembre

Italy's Official Journal no. 283 of 27 November 2021 has published the text of law no. 175 dated 10 November 2021 containing “Provisions for the treatment of rare diseases and for the support of research into and production of orphan drugs” (the Consolidated Law on Rare Diseases), whose purpose is to ensure the protection, at multiple levels, of the health rights of individuals affected by the pathologies in question.

Specifically, after article 1 sets out the measures to guarantee the intention of the law, articles 2 and 3 define the terms rare disease and orphan drug. Article 4 assigns to the reference centres indicated by ministerial decree 279/2001 the formulation of the personalised diagnostic, treatment and care plan for an individual affected by a rare disease, and also provides a structured procedure for the transition from paediatric care to adult care.

Article 5 sets out provisions to ensure pharmaceutical support and the immediate availability of orphan drugs, and, under certain conditions, allows for drugs marketed in other countries to be imported, eventually for uses not authorised in the countries of origin, provided that such uses are envisaged by the diagnostic, treatment and care plans. Article 6 establishes a solidarity fund for people affected by rare diseases, which will finance the measures to support people affected by these pathologies, and provides for an implementing regulation to be adopted by the Ministries concerned within three months of the law coming into force.

Furthermore, the law defines the functions of the national centre for rare diseases and the creation of the national committee for the pathologies in question (arts. 7 and 8) and provides for the approval every three years of the national plan establishing objectives and related activities in this area (art 9). The law also involves the Italian Regions, requiring them to ensure the flow of information on the rare disease networks to the national centre, in part to guide and support national planning and control activities (art. 10).

The law provides that as from 2022 the national fund for the use, at the expense of the Italian national health service, of orphan drugs for rare diseases and of drugs offering hope of a cure, pending marketing, shall be supplemented by an additional contribution by the pharmaceutical companies corresponding to 2% of their self-certified expenses to the overall expenditure incurred during the previous year for promotional activities addressing healthcare personnel (the fund currently operates through the AIFA and is funded with 2.5% of the expenses in question; consequently, with the new law, the contribution of the pharmaceutical companies will rise to 4.5%).

The competent Ministries are required to identify (within 6 months of the law coming into force) the criteria and procedures for accessing the subsidies envisaged by article 12 to support research work, to promote independent research in the area of rare diseases (art. 13), and to promote measures to provide patients and their families with correct information and raise public awareness.

The law certainly lays the basis for a significant legislative change on this important and sensitive question. It will come into force on 12 December 2021.

16 Febbraio

With sentence no. 1295 of 15 February 2021, the Council of State ruled on the legitimacy of the assignment of a municipal pharmacy to its employees, by virtue of the exercise of the right of first refusal provided for by Art. 12 of Law no. 362/1991, to municipal employees, following the ruling of the Court of Justice of 19 December 2019, C-465/18, which sanctioned the incompatibility of this provision with Community law due to its conflict with Community principles on competition.   In particular, the European Court held that the EU Treaty must be interpreted in the sense that it precludes a national measure that grants an "unconditional" right of first refusal, such as that contemplated by the aforementioned Art. 12 of Law no. 362/1991, while having also stated that the "objective of capitalising on the professional experience gained may be attained through less restrictive measures such as the award of additional points under the tendering procedure to tenderers who provide proof of experience in managing a pharmacy". In this context, the supreme administrative court affirmed that "the interpretative judgement of the Court of Justice issued following a preliminary ruling is comparable to a regulatory contingency, which, as it affects a proceeding still in progress and an interest not covered by the judgement, is not suitable to cause a conflict, but a chronological succession of rules governing the same legal situation". It thus retained that the Community sentence was directly applicable to the case in question, and ordered the annulment of the awarding of the pharmacy to municipal pharmacist employees. Nevertheless, the Council of State did not retain the decision of the judges of first instance to be legitimate: they ordered the direct assignment of the pharmacy to the applicant, in the light of the interpretation of Art. 12 of Law no. 362/1991 that was made by the Court of Justice, in the sense "that it legitimises the provision of conditional forms of the right of first refusal, which can well be left to the discretion of the administration". For this reason, the judges of second instance held that the Municipality is required to "repeat the tender procedure, with the provision of a right of first refusal compatible with Art. 49 of the Treaty", taking into account that "the attribution of a points system in the tender as regards municipal pharmacy employees, to which the same sentence of the Court of Justice expressly gives "merit" as a proportionate means of "enhancement" of the skills acquired, could represent the suitable means, in the reconciliation of interests, to satisfy the public interest in health-related manners".

17 Settembre

On September 15th, Cosmetic Europe (the European Association of the Cosmetics Industry) published the updated version of the Charter and Guiding Principles on Responsible Advertising and Marketing Communications document, first adopted in 2012. The update became necessary for the Charter to more efficiently address the challenges that today's highly digitized world entails, in the context of a fast-paced evolution of technologies, and rapid development of new forms of digital advertising and marketing communication practices.

The new document, following the path already outlined in the previous version and integrating the existing legislative framework, defines the European common line for the creation of responsible advertising and marketing communications that respect the human being, body image and human dignity, via all media.

The Charter also re-emphasizes the importance of image honesty, pointing out, in particular, the need to ensure that the digital techniques used do not alter the images of the models presented in such a way that the characteristics of the body become unrealistic and misleading with respect to the performance achievable by the product. The Charter also provides a set of new useful indications for influencer marketing, which are essentially aimed at making genuine and impartial opinions easily distinguishable by consumers with respect to the promotional messages that may be disseminated by influencers.

The Charter also includes specific commitments with reference to the responsible advertising and promotional communication towards vulnerable consumers, including children and teens, with a special focus on advertising via social media platforms, smartphones applications and games.

Another key issue addressed is responsibility in promoting the “eco-friendly” products. Marketing communication should be so framed as to empower consumers to make sustainable choices. For this purpose, specific attention is paid to a series of aspects regarding the general presentation of a product, the use of images, symbols and logos, as well as the accuracy, relevance, clarity and substantiation of environmental claims.

The text of the Charter and Guiding Principles on Responsible Advertising and Marketing Communications is available on the website of the Cosmetic Europe association (https://cosmeticseurope.eu/).

31 Luglio

The EDPB (European Data Protection Board) has published the document "Frequently Asked Questions on the judgement of the Court of Justice of the European Union in Case C-311/18 – Data Protection Commissioner v Facebook Ireland Ltd and Maximillian Schrems" online (edpb.europa.eu) in order to answer to frequently asked questions received by the supervisory authorities on the judgement of 16 July 2020 (in case C-311/18, so-called "Schrems II"), with which the Court of Justice declared the invalidity of the Privacy Shield (Implementing Decision of the European Commission 2016/1250), on which the lawfulness of the transfers of personal data from Europe to the United States was based to date.

For the Court of Justice, US legislation does not guarantee a level of protection deemed substantially equivalent to that guaranteed within the Union, since it offers to public authorities, in implementation of surveillance programs, access to personal data transferred from the EU to the United States, without granting data subjects rights actionable in the courts against the US authorities. While confirming the validity of European Commission Decision 2010/87 on standard contractual clauses, the Court of Justice established that before any transfer of personal data to a third country takes place on the basis of these clauses, it is necessary for an assessment to be performed of the level of protection guaranteed by the country of destination.

With the aforementioned document, the EDPB provides clarifications on that decided by the Court of Justice in the Schrems II case, specifying that any transfer of personal data to the United States carried out on the basis of the Privacy Shield must be considered illegal, and transfers based on standard contractual clauses or binding corporate rules can be done only after a case-by-case analysis. However, transfers to third countries other than the United States may be made on the basis of standard contractual clauses or binding corporate rules, provided that the preliminary assessments established by the Court of Justice are carried out and supplementary measures are identified, where necessary.

29 Giugno

On 2 June, the European Commission launched a public consultation for the reform of regulatory framework for digital services (the Digital Services Act Package). This consultation set to expire on 8 September 2020 and all public and private persons will be able to provide their own support in this important initiative.

The consultation follows two lines:

1) the proposed law on digital services, to update the e-commerce directive dating back to 2000, to adapt it to the new and growing needs that the online word imposes. It aims to establish a more effective governance system to ensure the correct application of these rules throughout the EU single market, while respecting fundamental rights;

2) the proposal for a new discipline that can adequately address and overcome the disparity of conditions of access to the European digital market, whose control by a handful of online platforms has created market imbalance by limiting consumer choice and reducing the competitiveness of digital services.

The following issues covered by the consultation are identified as essential for the reform: (i) the safety of online users, to be ensured also with the collection of data relating to illegal activities (e.g. the sale of dangerous and counterfeit products, misleading advertising, etc.); (ii) reform of the liability regime provided for by the e-commerce directive as regards digital services, to define the role and obligations of intermediaries, including those that are based outside of the EU but operate on the internal market; (iii) the gatekeeper role of digital platforms and the function they perform from a privileged market position in filtering news and content; (iv) transparency as regards online advertising; (v) opportunities and difficulties encountered by workers in the provision of services through online platforms, so that health and safety in the workplace can be protected; and (v) the creation of a governance system that ensures the correct application of the rules at a European level, and guarantees the respect of fundamental rights in the single digital market.

Following the consultation, the Commission will work on the reform proposals which will be presented to the EU Parliament and the Council for their evaluation and approval by the end of this year, in following the European legislative procedure (the link to access to consultation is provided below https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12417-Digital-Services-Act-deepening-the-Internal-Market-and-clarifying-responsibilities-for-digital-services). 

05 Maggio

The Commission has published three guidelines for manufacturers in order to increase the safe manufacture of medical equipment given the ongoing pandemic, mainly as regards masks and other personal protective equipment (PPE), non-rinse cleansers and hand disinfectants, and 3D printing for medical use.

The first guideline (containing "Conformity assessment procedures for protective equipement") provides indications for assessing the legal and technical requirements for the production of protective devices such as masks, gloves, and surgical gowns (which are in large part considered personal protective equipment, and therefore fall within the scope of Reg. 2016/425), as well as the manufacture of devices for intensive care and other medical equipment (which may fall within the field of application of the legislation on medical devices).

The second guideline, containing "Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)", provides useful tools for the correct qualification of hand cleaners and disinfectants, and clarifies when a product is to be intended as cosmetic or biocide for regulatory purposes. The document mainly serves to provide indications on the correct interpretation of labels that use terms such as "anti-bacterial": these always require a case-by-case assessment, given the manner in which the product is presented to the consumer as a whole.

The guidelines for "Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19" provide indications on the conformity assessment procedures for 3D printing and 3D printed products for medical use. It refers to applicable legislation within the EU, which includes the "harmonised European standards", and provides indications on the correct qualification of such products, which may also fall into the category of medical devices, with the consequent application of current regulatory provisions on the matter (the text of the Guidelines is available on the European Commission website, at https://europa.eu/european-union/index_en).

28 Aprile

A company that manages an online marketplace cannot be held responsible for the sole fact of storing the products of third-party retailers in its own warehouses that bear counterfeit trademarks. This was established by the EU Court of Justice in the proceedings that involved a German company that owns a well-known perfume brand and two companies of the Amazon group, as regards the hypothesis that subjects unaware that they store products in their warehouses on behalf of a third party that violate a trademark are making "use" of the trademark in a manner prohibited under European legislation. The Court assessed the applicability of Art. 9 of Reg. 207/2009 (replaced by Reg. 1001/2017), which states that the trademark owner has the right to prohibit others from "offering the goods, putting them on the market or stocking them for those purposes" in the event that only the third party proposes to sell or market these products. This clarifies that the concept of unlawful "use" of a trademark of others implies active conduct and direct or indirect control over the act constituting such "use", such that only those who perform the act are actually capable of ceasing it.

On this basis, the Judges declared that if is true that an economic operator who "uses" a sign identical to a trademark by importing or placing goods in storage that bear a trademark that it does not own for the purpose of sale, then the operator who stores them must personally pursue the purposes of offering the products stored for sale or putting them on the market in order for storage to be qualified as "use" of identical or similar trademarks. Consequently, the aforementioned rules must be interpreted as meaning that a person who holds products on behalf of a third party that infringe a trademark and is not aware of such infringement, must be deemed not to store these products for the purpose of their sale or placement on the market pursuant to the aforementioned provisions, if said person does not pursue the above purposes.

Lastly, it is interesting to note that the Court has left a potential liability for managers of online marketplaces as regards laws that differ from those mentioned above, namely with reference to the provisions on the liability of hosting providers pursuant to Art. 14 of Dir. 2000/31, as proposed by the company that owns the trademark subject to counterfeiting. However, the Court limited itself to acknowledging that it was unable to rule on the matter, as it was only able to examine the questions for a preliminary ruling by the national court, which had not raised this issue  (EU Court of Justice, judgement of 2 April 2020, in case C-567/18).

25 Marzo

The European Medicines Agency warned the general public to be careful while buying medicinal products and to avoid unauthorised websites and other vendors who exploit fears and concerns during the ongoing pandemic of COVID-19.
According to EMA, some vendors may claim that their products can treat or prevent COVID-19 or may appear to provide easy access to legitimate medicines that are otherwise not readily available. Such products are likely to be falsified medicines.
For these reasons, the Agency recommends to european citizens to buy medicinal products only by a local pharmacy or an online pharmacy duly authorized, that has the logo provided for by the european law, and reminds the public that there are currently no treatments authorised for COVID-19.
EMA also indicates the rules for keeping safe when buying medicines:
  • falsified medicines can cause serious harm
  • when buying over the internet, only use registered online pharmacies
  • check that the online pharmacy you are using has the common logo
  • click on the logo and confirm that the online pharmacy is listed on the national authority website
  • do not buy medicines advertised as cures or preventive treatments for COVID-19. To treat COVID-related symptoms such as fever, discuss with your doctor or follow advice from authorities.

05 Marzo

Prime Ministerial Decree of 4 March 2020 on "Further implementing provisions of Decree-Law no. 6 of 23 February 2020, containing urgent measures on the containment and management of the epidemiological emergency caused by COVID-19, applicable to the whole country" was published in Official Journal no. 55/2020, and is in force since yesterday. With this decree, the government orders the suspension of all congresses, meetings, and social events in which healthcare personnel or staff in charge of carrying out a public service or a public utility are involved, as well as the postponement of any other convention or congress until after 3 April 2020. The Prime Ministerial Decree above "prohibits patient companions from remaining in the waiting rooms of emergency and urgent care departments unless specifically indicated otherwise by health personnel in charge", and limits the access of relatives and visitors to hospitals and long-term care facilities, assisted healthcare residences, and residential facilities for the elderly, both self-sufficient and non, limiting access "only to cases indicated by the health management of the facility, which is required to take the measures necessary to prevent any transmission of infection". The measure on telecommuting remains in place throughout the country. It should be noted that Articles 3 and 4 of the Prime Ministerial Decree of 1 March 2020 (on information and prevention measures throughout Italy) cease to produce effects, as they have been replaced by the provisions of the Prime Ministerial Decree of 4 March 2020.

03 Marzo

Decree-Law no. 9/2020 on "Urgent support measures for families, workers, and businesses as related to the epidemiological emergency from COVID-19" was published in the Official Journal (no. 53 of 02.03.2020), with which measures are urgently introduced to ensure economic support for citizens and businesses facing issues of financial liquidity due to the ongoing health emergency. Many significant emergency measures have been put into place by the government, from the suspension of obligations and payments of taxes until the end of April 2020, for natural and legal persons whose residence, registered office, or operational headquarters falls within the cities in what is defined as the "red zone", to the provision of specific measures for tourism and hospitality businesses located throughout the country. As regards employment, the government has established special temporary procedures for companies with operating units in red zones and/or workers that reside in the area and are thus unable to work, with derogations from the union consultation as regards the deadlines for formalising "cassa integrazione"  procedures and/or for accessing the solidarity fund. Companies located within the red zone are offered to suspend extraordinary "cassa integrazione" procedures if they were already in progress before the health emergency, replacing it with the special ordinary procedure of "cassa integrazione" introduced by the Decree-Law in question. Two different types of procedures in derogation are then introduced, one with a duration limited to a maximum of 3 months, and one more specific that is solely for employers in the private sector, including the agricultural sector, with production units located in Lombardy, Veneto, and Emilia Romagna. This can be activated for a maximum duration of one month after a union agreement is signed, in order to contain the production-organisational prejudice suffered "as a result of the orders issued by the Ministry of Health, in agreement with the regions, in the context of measures taken with Decree-Law no. 6 of 23 February 2020". On the self-employment and professional front, an allowance of 500 Euro per month is granted for a maximum of three months, for workers who have coordinated and continuous freelance relationships, for commercial agents, professionals and self-employed workers who are domiciled or who carry out their activities in cities in the red zone.

02 Marzo

The Prime Ministerial Decree of 1 March 2020 (OJ no. 52 of 1 March 2020) on "Further implementing provisions of Decree-Law no. 6 of 23 February 2020, containing urgent measures on the containment and management of the epidemiological emergency caused by COVID-19" enters into force on 2 March 2020, with which the Government confirms a large part of the emergency measures adopted starting from 23 February 2020, reiterating the restriction within the perimeter of what is identified as the red zone, which includes the prohibition of work activities, unless it is possible to work remotely or the work concerns of essential public services or of public utility. With reference to regions in what is identified as the yellow zone, in addition to confirming the previous measures, the government has also provided for the "suspension of the ordinary leave of health and technical personnel, as well as for personnel whose activities are necessary to manage the activities requested by the crisis units set up at a regional level", and the extension of telecommuting throughout Italy (until 8 March 2020) as an exceptional measure. This gives all companies the right to have their employees work remotely, without needing to have an agreement (this was previously limited to certain areas only). It should be noted that the Prime Ministerial Decree in force from today's date replaces the previous decrees of 23 and 25 February 2020 and any other special provision adopted to date, including regional interventions implemented by the government, and therefore becomes the main source of reference for the regulation of the state of emergency.

On the central convergence of competences on the matter, the Regional Administrative Court of Marche issued a presidential decree with which the regional provision ordering the closure of schools was suspended. The collective hearing is set for 4 March.

26 Febbraio

The Prime Ministerial Decree of 25 February 2020 (G.U. 47 of 25/02/2020) is in force on "further implementing provisions of the Decree-Law no. 6 of 23 February 2020, containing urgent measures on the containment and management of the epidemiological emergency caused by COVID-19", as a partial amendment of the previous Prime Ministerial Decree of 23 February 2020. In addition to extending certain restrictive prevention measures (such as the suspension of sporting events and competitions) "in all cities in the regions of Emilia Romagna, Friuli Venezia Giulia, Lombardy, Veneto, Liguria and Piedmont", the government provided for the provisional application of smart working until 15 March 2020 for all employers whose registered office or operational headquarters are located in the regions of Emilia Romagna, Friuli Venezia Giulia, Lombardy, Veneto, Liguria and Piedmont, as well as for workers residing or domiciled in the aforementioned regions, "even if individual agreements are not in place" pursuant to ordinary legislation.

24 Febbraio

With Decree-Law no. 6/2020 in force since 23 February 2020 (OJ no. 45 of 23/2/2020) on "Urgent measures for the containment and management of the epidemiological emergency deriving from COVID-19", the government has been authorised to take containment and management measures on the spread of the virus in certain sensitive areas (namely 10 municipalities in Lombardy and 1 in Veneto). In implementation of the Decree-Law no. 6/2020, the Council of Ministers has provided for provisions regarding business activities, including the suspension of the performance of work for all workers residing or domiciled, even de facto, in the municipality or area affected by the measure, even if such work takes place outside of the municipality or area indicated. In addition, Art. 3 of the aforementioned Council of Ministers Decree provides for the application of smart working "automatically to every employment relationship within areas considered at risk, even in the absence of individual agreements", thus imposing remote work without the need to formalise individual agreements with employees. It is the first special provision of labour law that aims to face the emergency, though it currently only applies to municipalities considered most at risk. Companies that do not fall within the scope of the PMD will still be able to assess appropriate actions to be taken by applying the general rules on the impossibility of work performance, the use of income support tools (CIGO and FIS) and health and safety in the workplace with regard to biohazard prevention.

 

07 Febbraio

 

The EU Court of Justice has identified the criteria according to which an amicable settlement between the owner of a pharmaceutical patent and a manufacturer of generic medicines is contrary to the rules of the TFEU established to protect competition.

Notably, the Court of Justice clarified that the owner of a patent for the manufacturing process of an active ingredient that has become public domain and the manufacturers of generic medicines that are preparing to enter the market of the originator are in a potential competitive situation. In various case law, contradiction is seen on the validity of this patent or the counterfeit nature of generic medicines if it is shown that the manufacturer of generic medicines actually has the definitive approval and ability to enter the market; it should not face obstacles to such access of an insurmountable nature (a circumstance that is for the referring court to verify).

In addition, the Court ruled that the agreement to settle a pending court case between a producer of originator medicines and a manufacturer of generics in competitive situations by means of which the latter agrees not to enter the originator's market and not to continue its action of nullity of the relative patent during the period of validity of the agreement, in exchange for transfers of money by the manufacturer of the originator medicines, constitutes an agreement aimed at preventing, restricting, or distorting potential competition.

This is provided that:

i. all the available elements show that the positive transfer amount from the owner of the originator medicine to the manufacturer of generic medicines is explained only by the commercial interest of the parties in agreeing not to enter into competition based on the merits;

ii. the amicable settlement in question is not accompanied by proven beneficial effects for competition, such as to reasonably doubt that it would be substantially damaging to competition.

Lastly, the EU Court stated that an amicable agreement of the company that owns the originator that serves to temporarily keep potential generic-producing competitors out of the market constitutes the abuse of a dominant position within the meaning of Art. 102 of the TFEU, if such strategy is suitable for limiting competition (Court of Justice, judgement of 30 January 2020, in case C-307/18).

20 Dicembre

With its sentence of 19 December 2019 (case C-465/18), the EU Court of Justice ruled on the compatibility of Art. 12(2) of Law 362/1991, which grants employees the right of first refusal in the event of a transfer of ownership of a municipal pharmacy. The issue was raised by the Council of State during a dispute on the transfer of a municipal pharmacy; administrative courts found this rule to be in conflict with the principles of free competition and equal treatment contained in EU law. The Court of Justice found that the recognition of the unconditional right of first refusal granted to employees of a municipal pharmacy subject to transfer is likely to dissuade pharmacists from other Member States from participating in this procedure, constituting a restriction to the freedom of establishment provided by Art. 49 of the TFEU. This restriction was not deemed justified, as the rights of employees are guaranteed by Italian law by that provided for in Art. 2112 of the Civil Code, and employees of municipal pharmacies have not been proven to have greater professional experience, quality of service provided, or functions performed as regards the objective of protecting health. In recognising the incompatibility of the national rule with the Art. 49 of the TFEU, EU courts concluded by stating that the objective of enhancing professional experience pursuant to Art. 12 above can also be achieved through less restrictive measures, with respect to the recognition of an unconditional right of first refusal, such as the assignment of scores, as part of the tender procedure, for participants who provide proof of experience in pharmacy management.      

04 Dicembre

On 26 November 2019, Directive (EU) 2019/1937 of the European Parliament and the Council "on the protection of persons who report breaches of Union law" has been published in the Official Journal of the European Union, with the aim of strengthening the application of European Union law and policies in specific sectors deemed "sensitive" (e.g. public procurement, environmental protection, public health, consumer protection, and privacy). The Directive establishes common minimum standards for all member states in order to ensure a high level of protection of individuals who report violations of EU law (whistleblowers), with particular regard to those who acquire news of illegal offences in the workplace. This applies to private and public companies, even during the hiring process or if the employment relationship is no longer in place, and urges states to adopt specific rules in order to prioritise the adoption by private companies and public bodies of internal channels for reporting illegal offences, with the obligation for private sector companies with at least 50 employees to have at least one permanent internal reporting channel. The Directive also contains some important connecting rules between the protection granted to whistleblowers and the protection of personal data, both of the reporting person and person being reported, expressly referencing to EU Regulation 2016/679 (GDPR). A transitional period is provided for, within which the states must adapt their own regulations in general terms by 17 December 2021, while private companies with more than 50 employees will have until 17 December 2023 to introduce and/or adapt their internal reporting systems.

14 Novembre

With sentence no. 867 of 29/10/19, the Court of Appeal of Cagliari acknowledged the legitimacy of the presumptive reasoning in ascertaining the offence as regards the abuse of privileged information on investments, emphasising the need for the circumstantial evidence provided in support of the dispute to allow for an unambiguous reconstruction of what took place, having to identify the unknown fact through indirect known facts taking place through a rigorous reconstruction that allows a univocal reading of the elements acquired, with the exclusion of the likelihood of other similar alternative connections. With respect to this, they neither constitute univocal elements such as to give rise to the presumption of knowledge of privileged information, nor does the fact that the sanctioned subject is a usual stock market investor, given that nothing can exclude that the investor had invested in the shares on the stock exchange because of his/her experience, nor the fact that he/she had close family ties with another person that was reasonably in possession of privileged information, nor that frequent telephone contact between the former that can be explained with the same relationship. The limited investment in proportion to availability or the possibility of obtaining additional financial resources is certainly not in the favour of the knowledge of privileged information.

11 Novembre

With sentence no. 4188 of 17/10/19, the Court of Appeal of Milan returned to the contract requirements for investments in Over the Counter derivative financial instruments, declaring their nullity in the event that they do not contain all of the elements required for the assessment of risk. In this case, the Court, in examining two Interest Rate Swap contracts, found the lack of indication of the Forward Euribor 3 month curve used to determine the playoff of derivatives, in addition to a failure to indicate the Market to Market at the time the contract was stipulated, and the mathematical formula used to update future flows deriving from the execution of derivatives. This implies that contractual will was not present, as the customer was unable to assess the risk as regards the contract swap, which is an essential element of the margin due to the bank (which influences the initial Market to Market) and, therefore, the risk assumed by each party.

22 Ottobre

On 2 October, the Advocate General at the EU Court of Justice filed his conclusions in Case C-465/18 on the request for a preliminary ruling filed by the Council of State on 18 July 2018, aimed at understanding if the principles of freedom of establishment, non-discrimination, equal treatment, protection of competition, and freedom of movement for workers, pursuant to Articles 45, from 49 to 56 and 106 of the TFEU, Articles 15 and 16 of the Charter, and the canon of proportionality and reasonableness contained therein, preclude a national regulation, namely Art. 12(2) of Law no. 362/1991, which, in the event of transfer of the ownership of a municipal pharmacy, assigns the right of first refusal to the employees of such pharmacy.

In the opinion of the Advocate General, the rules on the freedom of establishment pursuant to Art. 49 of the TFEU precludes national legislation, which recognises the right of first refusal to municipal pharmacy employees in the event of its transfer, as this discipline has the effect of hindering and discouraging pharmacists of other Member States to exercise their right to participate in the tender procedure to purchase a municipal pharmacy located within the Italian Republic.

This rule does not seem to constitute a restriction on the freedom of establishment as justified by general interest, such as the protection of public health, since the aim is to guarantee the continuity of employment of pharmacists of municipal pharmacies in order to safeguard their rights in the event of the transfer of ownership of such pharmacy, which is based on social and occupational considerations rather than those of public health. Lastly, the Advocate General pointed out that this objective cannot be justified for the protection of employees against dismissal in the event of transfer of a municipal pharmacy, against the protection guaranteed by Art. 2112 of the Italian Civil Code.

24 Giugno

Administrative sanctions for violating the financial intermediation provisions also affect members of the Board of Statutory Auditors. The complexity of the organisational structure of the intermediary does not imply the exclusion or weakening of the power-duty of control attributable to each of the board members, who, in the event of an ascertained lack of corporate procedures on the provision of negotiation services, can be sanctioned as part of an omission quoad functione, since the responsibility falls on auditors both for the obligation of supervision to protect the interests of shareholders against acts of abuse in management by administrators and verification of the correct operation of the intermediary pursuant to the provisions of the Consob regulation that serves as a guarantee for investors, as well as for the obligation to immediately report violations as regard securities brokerage to the Banca d’Italia and Consob. See the Court of Cassation, Section III Civil, with Ordinance no. 4723 of 19/2/19.

20 Giugno

With sentence C-55/18 of 14 May 2019, the European Court of Justice was called upon to rule on the appeal filed by a Spanish trade union, which asked it to ascertain whether European community labour law could lead to the obligation for employers to set up a system for logging working hours that allows for the verification of the hours set by the employment contract; for Spanish legislation, this would also include the sending of monthly overtime hours to trade union representatives. In rendering its sentence, the Court of Justice affirmed that the limitation of the maximum duration of working hours is effectively a fundamental right of the worker as also established by European Union legislation, which includes the right to daily and weekly rest periods. Consequently, Member States are required to issue internal regulations that oblige employers to track all employee work hours, so that it is always possible to verify the number of hours of work carried out, their distribution over time and the number of hours worked overtime.

13 Giugno

On 12 June 2019, the new decree on clinical trials for medicinal products for human use (Leg. Decree 52/2019) was published in the Official Journal. In implementing the provisions of Art. 1 of Law 3/2018 (the so called "Lorenzin Law") "delegating powers to the government with regard to clinical trials for medicinal products and provisions for the reorganisation of health professions and the healthcare managers of the Ministry of Health", the new decree impacts current legislation on clinical trials (Leg. Decree 200/2007 and Leg. Decree no. 211/2003). Among the main changes made by Legislative Decree 52/2019, it is noted that Art. 1, "in order to enhance non-profit clinical trials with a low level of intervention" introduces the possibility of transferring the relative data and results for registering purposes, with the obligation of the sponsor to sustain and reimburse direct and indirect trial-related expenses, as well as the relative tariffs if the trial is requalified as a for-profit activity, inclusive of potential revenue deriving from the enhancement of intellectual property. The issuance of a specific decree of the Ministry of Health is foreseen, which provides for a discount scheme for good clinical practice inspections on phase I studies, and the competence for sanctions is transferred from the Ministry of Health to AIFA, as the Authority competent in the field of clinical trials for medicinal products. Article 2, which amends Leg. Decree 211/2003, provides for a single national form for the purpose of submitting an application for the opinion to the Ethics Committee, and requires AIFA to publish the list of facilities authorised to conduct clinical trials. Chapter II of the decree contains provisions for coordination with Reg. 536/2014 on trials, and, in addition to referencing the definitions contained therein, establishes that the Ministry of Health, by means of a decree, adapts the governance on the suitability of facilities at which the clinical trial is conducted to the provisions of the European Regulation, and that within 90 days from the issuance of this decree, AIFA identifies the requirements for the authorisation of centres to conduct trials from phase I to phase IV. The Ministry of Health must also identify the criteria and guidelines for the authorisation of centres for clinical trials of advanced therapies, and AIFA, having consulted the National Coordination Centre of Ethics Committees, will have the task of identifying suitable methods to protect the independence of clinical trials and ensure the absence of conflicts of interest. In this regard, it is envisaged that, in order to guarantee neutrality and impartiality, the subjects appointed with the validation and subsequent evaluation of the application for authorisation of a clinical trial make a declaration as to the absence of conflicts of interest, and that the Ministry of health, subject to agreement in the State-Regions Conference, orders the suppression of any territorial Ethics Committees that violate the terms and procedures on the evaluation of clinical trials or the rules on transparency and on the absence of conflicts of interest. Lastly, two ministerial decrees must, respectively, redefine the procedures for evaluating and authorising clinical trials, and identify the general criteria on the basis of which universities can initiate master's degrees on the methodology of clinical research and trials (Leg. Decree no. 52 of 14 May 2019, published in Official Journal no. 136 of 12 June 2019).

06 Giugno

"EU institutions and bodies are required to respect the fundamental rights of the European Union, which include the right to good administration enshrined in Article 41 of the Charter" [of fundamental rights], which, in paragraph 1, establishes that every person has the right to have his or her affairs handled impartially.

The requirement of impartiality aims to guarantee equal treatment, which is a basic principle of European law, in order to avoid situations of potential conflict of interest for officials acting on behalf of institutions. Given the fundamental importance of guaranteeing independence and integrity as regards both internal operation and the external image of EU institutions, this requirement of impartiality must cover all of the circumstances that an official called upon to comment on a case must reasonably understand as likely to appear, in the eyes of third parties, as capable of influencing independence in the matter.

Consequently, the requirement of impartiality must be ensured both from a subjective point of view, in the sense that none of the members of the institution concerned must express preconceived opinions or personal prejudices, as well as from an objective point of view, in the sense that the institution is bound to offer sufficient guarantees to exclude any legitimate doubt as regards potential prejudice.

On the basis of these principles, in annulling the judgement of the first instance, the EU Court of Justice declared the decision adopted by the European Commission on the renewal of the marketing authorisation of a medicinal product to be illegitimate. The decision was adopted on the basis of the opinion given by the Committee for Medicinal Products for Human Use (CHMP) of the EMA, whose main rapporteur was an employee of the national authority that had previously issued a decision refusing the renewal of the marketing authorisation for said medicinal product. Furthermore, the employee had defended the aforementioned authority in the appeal against the decision before national judges, and initiated the procedure before the Committee itself (EU Court of Justice, judgment of 27 March 2019, in case C-680/16P).

30 Maggio

With judgement no. 1753 of 16 April 2019, the employment judge of the Court of Lecce upheld the appeal of a general practitioner who argued that the monthly reduction of his salary ordered by his local health authority, after he prescribed oxygen cylinders over the limits set by the relevant guidelines for a single patient, was illegitimate. The defence of the general practitioner was that the case in question forced him to deviate from the guidelines, while the local health authority insisted on the need for a rigid interpretation of the guidelines. In its judgement upholding the appeal, the Court clarified that an over-rigorous interpretation of the meaning of the guidelines and of the effects of possible breaches of prescriptions or indication is detrimental with respect to the need to safeguard health as a fundamental right under art. 32 of the Italian Constitution, as it could place the medical practitioner in a difficult dilemma between his responsibility to his patients and the risk of salary deductions as a result of prescriptions he deems necessary in the particular case that are not compliant with the guidelines. The Court of Lecce concluded by stating that the medical practitioner must be afforded a degree of discretion and that personal liability can be found only in the event of wilful default or clear error.

29 Maggio

On 28 May 2019, the World Health Organisation (WHO) approved the resolution proposed by Italy, together with 18 other countries, to improve the transparency of the prices and patents of medicinal products, vaccines and other healthcare products. The purpose of the initiative is to help the Member States take better-informed decisions when purchasing healthcare products, negotiate more accessible prices and thereby broaden public access to these products. The availability of comparable information should facilitate greater cost-effectiveness and equal access to healthcare products.

The resolution invites the Member States, in accordance with their national laws, to implement systems for public dissemination of information on the actual prices of healthcare products and to guarantee greater transparency of information about the status of their patents.

Furthermore, the Director General of the WHO is entrusted with a number of tasks to support and monitor the activities introduced by the Member States. Specifically, the DG is asked to support the development of national policies concerning the transparency of healthcare markets, and to convene the Fair Pricing Forum every two years, at which the Member States and all interested parties may take part to examine price accessibility and transparency and the costs of healthcare products.

28 Maggio

With judgement no. 608 of 22 May 2019, the Piedmont Regional Administrative Tribunal (TAR) issued a ruling on a new question concerning the possibility for the Italian regional authorities to enable medical practitioners other than those employed by or with an agreement with the Italian national health service (SSN) to prescribe health services whose costs are borne by the SSN.

The TAR developed its reasoning from an examination of the challenged resolution of the Regional Council to investigate the resolution’s compatibility with the relevant national laws, specifically art. 2 decree law no. 443/1987, which expressly restricts use of prescription pads for state-funded services to medical practitioners employed by or with an agreement with the SSN. Consistently with the reconstruction of a previous ruling of the Constitutional Court (judgement no. 1103 of 20 December 1988), the TAR cites two fundamental reasons for the restriction ex art. 2 legislative decree no. 443/1987: on the one hand, it meets the need to restrict prescriptions, or proposed services deliverable by the SSN, to practitioners of proven competence; on the other, it avoids an anomalous and uncontrolled increase in prescription of medicinal products.

According to the reconstruction of the Piedmont TAR in the judgement in question, the laws subsequent to the above-mentioned decree law do not have either an implicit or an explicit revoking effect, indeed they highlight that the restriction is still evident in the relevant legislation, specifically in the technical regulations on the dematerialisation of hard-copy medical prescriptions (decree 2 November 2011 on “Dematerialisation of the hard-copy medical prescription, as per art. 11, paragraph 16, legislative decree no. 78/2010 - Medical Card Project”): prescribing cannot be mixed with the delivery of healthcare services, which would only appear to be exercisable also by accredited private healthcare bodies.

For these reasons the TAR annulled the ruling of the Piedmont Regional Council which extended the power to prescribe services whose costs are borne by the SSN to medical practitioners in private bodies (Piedmont TAR, Section I, ruling no. 608 of 22 May 2019).

19 Aprile

On April, 17th, the European Parliament approved the text of the new regulation on supplementary protection certificates; in amending Regulation (EC) 469/2009, it introduces the possibility for pharmaceutical companies established in the European Union to produce generics and biosimilars during the validity period of the supplementary protection certificate (SPC) of the originator product of reference in order to export them to a third country where the product patent has expired or never existed. It will also be possible to produce generics and biosimilars before the SPC of the originator product expires, in order to stock them in the EU and put them on the market immediately after the expiry of the certificate. The newly approved regulation also provides that certain information (such as manufacturer name and address, purpose of production, the Member State of production or storage) is communicated by the manufacturer of generics and/or biosimilars to the competent authority and to the holder of the SPC. These new provisions will apply from the date of entry into force of the regulation for new certificates requested from such date, and from 1 July 2022 will also apply to those previously requested and effective after the entry into force of the regulation itself.

00 Novembre

The EU Court of Justice has identified the criteria according to which an amicable settlement between the owner of a pharmaceutical patent and a manufacturer of generic medicines is contrary to the rules of the TFEU established to protect competition.

Notably, the Court of Justice clarified that the owner of a patent for the manufacturing process of an active ingredient that has become public domain and the manufacturers of generic medicines that are preparing to enter the market of the originator are in a potential competitive situation. In various case law, contradiction is seen on the validity of this patent or the counterfeit nature of generic medicines if it is shown that the manufacturer of generic medicines actually has the definitive approval and ability to enter the market; it should not face obstacles to such access of an insurmountable nature (a circumstance that is for the referring court to verify).

In addition, the Court ruled that the agreement to settle a pending court case between a producer of originator medicines and a manufacturer of generics in competitive situations by means of which the latter agrees not to enter the originator's market and not to continue its action of nullity of the relative patent during the period of validity of the agreement, in exchange for transfers of money by the manufacturer of the originator medicines, constitutes an agreement aimed at preventing, restricting, or distorting potential competition.

This is provided that:

i. all the available elements show that the positive transfer amount from the owner of the originator medicine to the manufacturer of generic medicines is explained only by the commercial interest of the parties in agreeing not to enter into competition based on the merits;

ii. the amicable settlement in question is not accompanied by proven beneficial effects for competition, such as to reasonably doubt that it would be substantially damaging to competition.

Lastly, the EU Court stated that an amicable agreement of the company that owns the originator that serves to temporarily keep potential generic-producing competitors out of the market constitutes the abuse of a dominant position within the meaning of Art. 102 of the TFEU, if such strategy is suitable for limiting competition (Court of Justice, judgement of 30 January 2020, in case C-307/18).