Highlights

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).