I INTRODUCTION

Although the Italian legislative framework on life sciences fully implements EU legislation on research and development, manufacturing, marketing, promotion and distribution of medicines and medical devices, the Italian legislature has adopted a more restrictive approach, compared to other EU Member States, in relation to advertising and promotion, interactions with healthcare professionals (HCPs) and healthcare organisations (HCOs), distribution and marketing of medicinal products.

Another peculiarity of the Italian system is the time-consuming and complex reimbursement procedure, which is driven by the need to balance patients' right to access innovative products, at the expense of the national health service (NHS), and cut public expenditure in the healthcare sector.

The main authorities in the Italian life sciences sector are:

  1. the Ministry of Health (MoH), which generally governs the Italian healthcare system and has a more specific role in relation to medical devices; and
  2. the Italian Medicine Agency (AIFA), a public entity under the supervision of the MoH, which is responsible, among others, for the manufacturing, distribution, import, promotion, advertising, pricing and reimbursement of medicines in the territory.

II THE REGULATORY REGIME

In the medicines and medical devices sector, the Italian legislative framework mainly consists of:

  1. Legislative Decree No. 219/2006 (the Pharma Code), which implemented Directive 2001/83/EC;
  2. Legislative Decree No. 46/1997, implementing Directive 93/42/EEC; and
  3. Legislative Decrees No. 507/1992 and No. 332/2000, which implemented, respectively, Directive 90/385/EEC on active implantable medical devices and Directive 98/79/EC on in vitro diagnostic medical devices.

Regulation EU 745/2017 (the Medical Device Regulation), repealing Directive 2001/83/EC, and Regulation EU 746/2017 (the IVD Regulation), repealing Directive 90/385/EEC, are expected to be effective as of 26 May 2020. The above regulations establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.

i Classification

There is no specific Italian provision addressing the distinction between medicines, medical devices and other regulated products (e.g., food supplements, cosmetics, chemicals and general consumer products). That said, the Pharma Code provides that, in cases of doubt, where a product may fall within the definition of a 'medicinal product' and within the definition of another regulated product, the provisions of the Pharma Code concerning medicines shall apply.

Moreover, Italy applies the guideline documents issued by the European Commission to support manufacturers in the classification of medical devices such as the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, the MEDDEV Guidelines and the documents issued by the Medical Device Coordination Group aimed at ensuring the uniform application of the relevant provisions of the Medical Device Regulation and the IVD Regulation within the EU.

In addition, the MoH occasionally issues guidelines to address specific products and clarify their classification criteria.

ii Non-clinical studies

Non-clinical studies should be carried out in accordance with the provisions of EU good laboratory practice laid down in Directives 2004/9/EC and 2004/10/EC.

All tests on animals shall comply with Legislative Decree No. 26/2014 on protection of animals used for experimental and other scientific purposes. According to said provisions of law, the committee for the protection of the welfare of animals, an internal body of the institution where the research is conducted, shall apply for MoH authorisations.

iii Clinical trials

Different pieces of legislation govern non-profit and for-profit clinical trials.

As to non-profit clinical trials, Legislative Decree No. 52/2019 has introduced new rules according to which data and results obtained from non-profit trials, financed by the Italian NHS, can be assigned to third parties if either the sponsor or the assignee refunds and reimburses any direct or indirect associated costs. The consideration paid in exchange for the ownership of the data and results shall also cover the costs of the clinical trial, including the reimbursement of any tax facilitation that the sponsor may have benefited from as a consequence of the trial's non-profit initial qualification. The above legislation repeals the prohibition on assigning data and results of non-profit clinical trials financed by the NHS to third parties, which was a peculiarity of the Italian system.

For-profit clinical trials are mainly governed by Legislative Decree No. 211/2003 and Legislative Decree No. 200/2007, which, among others, set forth specific rules on permits to carry out the trial, good clinical practice, informed consent, responsibilities of the sponsor, the investigators and the other entities involved in the clinical trials (e.g., contract research organisations). Less stringent rules govern observational studies, according to the AIFA Resolution dated 20 March 2008.

A clinical trial shall meet, among others, the following main requirements:

  1. the site where the trial is conducted shall comply with quality standards set forth by AIFA Determination No. 809/2015;
  2. the sponsor shall request from the AIFA an authorisation to carry out the trial. The authorisation is implicitly granted if the AIFA does not raise any objection within 60 days of the sponsor's application; and
  3. the relevant ethics committee shall issue its favourable opinion on the trial, assessing various scientific and economic aspects, such as the validity of the study protocol, the economic arrangements with the clinical trial site and the insurance policy, which shall cover potential damages arising from the trial according to Ministerial Decree of 14 July 2009.

EU Regulation 536/2014 on clinical trials on medicinal products will repeal Directive 2001/20/EC as soon as the EU web portal on clinical trials is activated. Among others, the Regulation provides for (1) a streamlined procedure for the submission of the applications and harmonised authorisation dossier; (2) a flexible and swift assessment procedure without establishing a new central bureaucracy; (3) a clear mechanism to appoint a 'reporting Member State'; and (4) a clear timeline for the issuance of the authorisation with the concept of implicit approval.

Medical devices

The above general principles on clinical trials on medicines also apply to medical devices, for which specific rules are set forth by Legislative Decree No. 46/1997 and by the MoH Guidelines of 15 April 2005.

Under Italian law, pre-market clinical investigations must be authorised by the MoH. The authorisation is implicitly granted if the MoH does not raise objections within 60 days. No authorisation is required for post-market investigations, for which a simple notification to the MoH is required.

iv Named-patient and compassionate use procedures

Compassionate use

According to Ministerial Decree dated 7 September 2017, compassionate use of medicine is available for (1) patients suffering from rare or life-threatening diseases, if no other valid therapeutic alternative is available; (2) patients who have already been treated with clinical benefit in a similar clinical trial; or (3) patients who cannot be included in a clinical trial.

The responsible physician can file a request for compassionate use provided that: (1) a Phase III clinical trial on the investigational medicine is undergoing (in exceptional cases it is allowed to provide medicines for which a Phase II or Phase I trial has been completed); (2) the requested medicine is already authorised for indications other than those required by the patient ('off-label use'); and (3) the medicine, although duly licensed, is not yet available in Italy.

Compassionate use programmes shall be notified to the AIFA and expire as soon as the medicine is placed on the market. The Italian Council of State, with its Opinion No. 2356/2016, stated that, even though the relevant medicine has already been placed on the market, patients can benefit from free-of-charge compassionate use until the reimbursement agreement has been approved.

Import of medicines authorised in a foreign country and shortage of medicines

According to the Ministerial Decree dated 11 February 1997, the import of unlicensed medicines is permitted in two cases: (1) if said medicine is duly licensed in a country outside of Italy; and (2) if a traveller import medicines licensed outside of Italy for his or her personal use in a quantity not exceeding his or her needs for 30 days. An ad hoc authorisation from the MoH is required.

Moreover, in the case of a shortage of medicine at a national level, the MoH can authorise the import of the same medicine available outside of Italy.

Innovative investigational medicines

According to Law No. 648/1996 innovative investigational medicines or off-label use of licensed medicines can be provided to patients at the NHS's expense, if the AIFA grants its authorisation.

Medical devices

In cases of exceptional need and urgency, in the interest of a single patient, the MoH can authorise the compassionate use of medical devices bearing no mark because the conformity assessment has not been conducted or completed. Compassionate use requires MoH authorisation and the approval of the relevant ethics committee.

v Pre-market clearance

Only medicines granted with a marketing authorisation (MA) from the AIFA or European Medicines Agency and medical devices bearing the CE mark (except for custom-made devices) can be placed on the market.

Furthermore, all medical devices, in order to be marketed in Italy, should be notified to the MoH and registered in an institutional register of medical devices.

vi Regulatory incentives

Supplementary protection certificate

National legislation prevents the NHS from reimbursing a generic medicine, where patent or supplementary protection is in place. This provision has been strongly criticised as representing a form, even if sui generis, of patent linkage, which is prohibited under EU law. In 2015, Assogenerici (the Italian Association of the Generic Medicines) filed a position paper with the Italian Senate requesting the repeal of the above provision on patent linkage.

Orphan medicines and innovative medicine

An AIFA National Fund is available for orphan medicines. The AIFA allocates to the fund 50 per cent of the contribution that pharmaceutical companies pay on an annual basis, which amounts to 5 per cent of the annual expenses for promotional activities of pharmaceutical companies. The sites where patients are treated with orphan drugs shall submit applications for access to the AIFA fund.

Moreover, the AIFA has issued a list of innovative medicines that can benefit from a specific national fund introduced by the Budget Law of 2017.

vii Post-approval controls

According to pharmacovigilance obligations provided by the Pharma Code, the marketing authorisation holder (MAH) must ensure a system to collect and maintain a record of suspected adverse events and equally ensure a safety reporting system to the AIFA. Specifically, the MAH shall set up a risk management system for each medicine, appoint a qualified person who shall be responsible for pharmacovigilance activities and notify his or her name to the AIFA.

The pharmacovigilance activities may lead to the suspension or revocation of product approvals by the AIFA, which ensure compliance with the provisions of law inspecting the MAH premises, records and documents in relation to the pharmcovigilance activities covered.

Moreover, according to the Pharma Code the MAH shall appoint a responsible person for distribution and a scientific service, which must be independent from the marketing department.

Medical devices

According to Section 9 of Legislative Decree No. 46/1997, the manufacturer (or its authorised representative) shall inform the MoH immediately of any incident, as well as of the corrective actions taken to reduce the risks of death or serious deterioration of the patients' health that may occur with the use of a medical device.

viii Manufacturing controls

A manufacturing site shall obtain an authorisation from the AIFA. To issue the authorisation, the AIFA must inspect the site and ensure that the applicant has qualified staff and adequate technical-industrial resources. The authorisation is normally granted within 90 days.

In the case of medicines and investigational medicines imported from third countries, the importer shall ensure that they comply with standards at least equivalent to those in force in the EU. Moreover, the importer shall ensure that medicines are manufactured by duly authorised manufacturers.

ix Advertising and promotion

Introduction and regulatory framework

The advertising and promotion of medicines and medical devices is governed by national legislation, as well as by regional legislation (i.e., laws and regulations issued by the various Italian regions) and industry codes.

In detail, the following pieces of legislation apply to the advertising of medicines and medical devices in Italy:

  1. the Pharma Code, implementing Directive 2001/83/EC, as amended, on the Community code relating to medicinal products for human use;
  2. Legislative Decree No. 46/1997 implementing Directive 93/42/EEC on medical devices; and
  3. Decree of the Ministry of Health dated 23 February 2006 on medical devices advertising.

Specific instructions on advertising of medicines and medical devices through different communication channels, including the internet, SMS/MMS and social networks, are established by various guidelines issued by the MoH.

At a regional level, the promotion of medicines and medical devices to healthcare professionals is regulated by the 'Guidelines for regional regulations regarding scientific information relevant on medicines' dated 26 April 2006, as well as by the guidelines issued by each Italian region.

Lastly, additional rules on advertising of both medicines and medical devices are also set out in the codes of conduct adopted by national and international industry associations, such as the Farmindustria and the EFPIA Codes for medicines, and the Confindustria Dispositivi Medici and the MedTech Europe Codes for medical devices. Said codes only apply to pharma and medical devices companies that are members of such industry associations.

Advertising to the general public

Advertising to the general public of prescription medicines or medicines containing psychotropic or narcotic substances is forbidden. The prohibition on advertising to the general public also applies to medicines that are reimbursed, even partially, by the NHS. The distribution of medicines to the public for promotional purposes is also prohibited.

In publications, radio or television broadcasting, or any non-promotional messages to the general public, it is prohibited to mention the name of a medicinal product in a context where this results in the promotion of the consumption of the product.

Similarly, it is forbidden to advertise to the general public custom-made medical devices and medical devices that must be ordered by, chosen by or ultimately used with the assistance of, an HCP.

The advertising of medicines and medical devices that do not fall within one of the above-mentioned categories is subject to prior authorisation by the MoH. This authorisation is implicitly granted if the MoH does not raise any objection within 45 days from the date of the filing of the relevant application.

Promotion to HCPs

Broadly speaking, the promotion of medicines and medical devices to HCPs is governed by concerns for accuracy in information, adequacy in education and training of medical sales representatives, and the avoidance of undue influence over HCPs' decision-making processes (including purchasing decisions by public entities). To this end, there are a number of restrictions on how information can be presented to HCPs with respect to seminars, panel discussions, promotional events and the like.

Any advertising of medicines to persons qualified to prescribe or supply such products shall always include the summary of the product characteristics authorised at the time the advertising is disseminated, specify the supply classification of the same product and the sale price and the conditions for its reimbursement by the NHS, if any.

The documentation on the medicinal product must be filed with the AIFA and can be supplied to the HCP after the expiry of a term of 10 days from the filing.

x Distributors and wholesalers

Italian legislation does not provide for any specific regulation governing the distribution of medical devices. Consequently, the sections below only refer to the distribution of medicines.

Wholesale distributors

Wholesale distributors purchase medicines directly from MAHs with the purpose of selling them to pharmacies and healthcare structures that are entitled to purchase medicines. These distributors must be authorised by the region or autonomous province in whose territory the relevant warehouse is located. A wholesale distributor holding warehouses in the territories of different regions or autonomous provinces must obtain an authorisation from each competent authority.

In carrying out their activities wholesale distributors must comply with the good distribution practices issued by the MoH (i.e., a set of rules governing the proper storage and transportation of medicines, traceability and registration obligations and public service obligations, consisting in the duty to ensure availability of a wide range of medicines and to promptly supply pharmacies located in a given area).

Depositaries

Unlike wholesale distributors, which own the title to medicines, depositaries merely store and distribute medicines to wholesalers and healthcare structures on behalf of MAHs pursuant to specific agreements entered into with the latter. Depositaries are subject to the same authorisation requirements applicable to wholesale distributors; however, they are not responsible for complying with public service obligations.

xi Classification of products

The classification of medicines is as follows:

  1. Class A: medicines for essential and chronic diseases that are entirely reimbursed by the NHS;
  2. Class H: medicines provided in hospitals, fully reimbursed by the NHS;
  3. Class C: all other medicinal products that are not reimbursed by the NHS; and
  4. Class Cnn: medicines not yet assessed for NHS reimbursement purposes.

With regard to their supply regime, medicines are classified as prescription-only, OTC and medicines that patients can purchase without prescription (SOP).

Medical devices

Medical devices are divided into Classes I, IIa, IIb, III, depending on their characteristics and on the potential risk on patients deriving from their use. Annex IX of Legislative Decree No. 46/1997 set forth rules to assess the classification of a device, which is based on the intended use indicated by the manufacturer.

Special classification rules apply to some categories of devices. In this respect, operating field systems and kits represent a particular type of medical device consisting of a series of devices, even if manufactured by different companies and of different classes, which may also include products not classifiable as medical devices, assembled together. An accessory is considered a medical device for all purposes and must be classified separately from the device with which it is used.

xii Imports and exports

Importing and placing on Italian market medicines from extra-EU countries requires a manufacturing authorisation from the AIFA. Moreover, the MoH Decree dated 11 February 1997 governs the import of medicines authorised abroad (see Section II.iv).

Import of medical devices requires health clearance by the Customs authorities.

xiii Controlled substances

The manufacturing, use for investigational and scientific purposes, marketing and distribution of narcotics and psychotropic substances is subject to specific authorisations by the Central Narcotics Office of the MoH, pursuant to Legislative Decree No. 309/1990. As indicated in Section II.viii, medicines containing narcotics and psychotropic substances cannot be advertised to the general public.

xiv Enforcement

The MoH, supported by the Anti-Adulteration Unit of the Carabinieri (NAS) and the AIFA, are the authorities in charge of adopting the necessary measures to ensure compliance, safety and patients' health. Depending on the kind of violation, enforcement activity may lead to restraining measures (e.g., an order to stop the illicit conduct), pecuniary sanctions or criminal sanctions. In the latter case, the competent body is the relevant criminal court.

III PRICING AND REIMBURSEMENT

Under Law No. 326/2003, the AIFA is the body in charge of negotiating the cost of medicines reimbursed by the NHS and, more generally, monitoring prices of medicinal products.

As to pricing, medicines not reimbursed by the NHS are governed by Law Decree No. 87/2005, under which the MAH can freely determine the price. The AIFA must ensure that: (1) price increases only occur every two years (odd years); and (2) price increases do not exceed the inflation level.

With respect to reimbursement, under Law No. 326/2003, prices reimbursed by the NHS are determined through a bargaining procedure between the AIFA and the concerned MAH in accordance with the modalities and criteria provided for by Resolution No. 3 of 1 February 2001 of the Inter-ministerial Committee for the Economic Planning.

The criteria for the evaluation of a medicine for reimbursement purposes are mainly the following: cost-benefit ratio, increased clinical benefit, considering cost-effectiveness, existence of alternative medicines or treatments, impact on the health system's budget, evaluation of the market sector related to the product, and the average price of medicines belonging to the same therapeutic area in other EU Member States.

In successful negotiations, the parties enter into an agreement setting the relevant price and the conditions for the reimbursement. The agreement may also provide for an expenditure ceiling applicable to the concerned medicinal product.

The price determined through the agreement is valid for a period of 24 months. Upon expiry, the agreement is automatically renewed for a further 24 months unless the parties agree to amend it within 90 days of the expiry date. The list of medicines reimbursed by the NHS is published on the Official Journal of the Italian Republic and is updated every six months.

On 1 August 2019, the State-Regions Conference expressed its positive opinion on a draft Decree establishing new criteria and procedures for price negotiation of medicines reimbursed by the NHS. The draft Decree provides for relevant changes to the existing system giving particular emphasis to the 'added therapeutic value' that the medicinal product must ensure with respect to the main treatments to which it is compared, thus replacing the current reference to the 'advantageous cost-effectiveness' ratio. The draft Decree also requires pharmaceutical companies to support their requests with information and self-certifications attesting their production capacity and ability to manage unexpected events as well as information concerning the patent status of the relevant medicinal product. To enter into force, the draft Decree must obtain the positive opinion of the Council of State, be reviewed by the Court of Auditors and, subsequently, be published in the Official Journal of the Italian Republic.

i Medical devices

There are no specific provisions of law governing the pricing and reimbursement procedure for medical devices. The NHS normally purchases medical devices through public procurement procedures.

ii Measures to control public expenditure on medicines and medical devices

A core factor affecting the pricing of medicines reimbursed by the NHS is the need to contain pharmaceutical expenditure. Over the past few years, the Italian legislature has introduced various measures to reduce public expenditure, among which are the following:

  1. Budgets allocated to pharmaceutical companies. The AIFA assigns each MAH of medicines reimbursed by the NHS a yearly budget, which represents the maximum amount that the NHS will reimburse to the MAH. If this amount is exceeded, the MAH shall pay back the difference to the AIFA.
  2. Budgets assigned to single MAs. In addition to the company's budget, the AIFA may assign a specific annual budget to single MAs relating to medicines reimbursed by the NHS. If the budget is exceeded, the MAH shall pay back the difference to the AIFA.
  3. Payback system for medicines and medical devices. The payback system for medicines provides that in the case of overrun of the national expenditure ceiling for medicines, pharma companies selling medicines reimbursed by the NHS are required to bear the relevant costs and payback to the NHS an amount of money proportional to the sales made to the various regions or autonomous provinces in which the expenditure ceiling has been exceeded. Although the payback system has been harshly criticised by pharma companies and challenged in various courts' proceedings, the legislature has extended it also to medical devices, pursuant to Law No. 125/2015. However, the payback system is still not effective for medical devices, until a decree of the MoH is issued to determine the specific modalities for calculation and payment of the relevant amounts.
  4. Managed entry agreements. The aim of managed entry agreements is to enable MAHs and payors to share the financial risk of the reimbursement of certain new medicines due to uncertainty surrounding the introduction of new technologies. Managed entry agreements can be outcome based, such as payment by results and risk sharing, or financial based, such as cost sharing agreements and capping.
  5. Direct distribution. Direct distribution is a form of (direct) supply of medicines to patients. Health authorities carry out this distribution by purchasing medicines from manufacturers and directly distributing them through their own structures to patients for home consumption. By excluding costs associated with the distribution by pharmacies, this instrument allows health authorities to achieve average savings of 50 per cent.
  6. Tender proceedings. Further reductions may be granted through tender proceedings under which medicines are supplied to public hospitals according to the criteria of the lowest price.

The regulatory framework on this matter is rapidly evolving and is experiencing constant adjustments and developments.

IV ADMINISTRATIVE AND JUDICIAL REMEDIES

The MoH and AIFA's decisions can be challenged before the relevant administrative court (in the first instance the Lower Administrative Court – TAR, while in the second instance the Council of State) within 60 days of their notification or actual knowledge. Alternatively, administrative decisions can be challenged before the President of the Italian Republic within 120 days.

V FINANCIAL RELATIONSHIPS WITH PRESCRIBERS AND PAYERS

The provisions of the Italian anti-corruption law apply to interactions with HCPs. Moreover, Section 123 of the Pharma Code provides that, in the context of promotional activities addressed to HCPs, it is forbidden to grant, offer or promise rewards, pecuniary advantages or benefits in kind, unless they are of negligible value and instrumental to the medical practice.

Specific rules apply to companies that are members of industry associations, whose code of ethics requires them to disclose on their website or on specific platforms various information on transfers of values to HCPs and HCOs.

Under the Farmindustria Code, all its members shall disclose transfers of value to HCOs and HCPs, related to (1) donations; (2) participation in conferences and congresses; and (3) consultancy and professional activities.

Under the Code of Ethics issued by Confindustria Dispositivi Medici, medical device companies must disclose all transfers of value directly or indirectly provided to HCPs and HCOs and third parties, related to (1) training, educational and promotional activities; (2) professional advice and services; (3) donations; (4) research and development activities; and (5) scholarships.

Under both the Farmindustria and Confindustria Dispositivi Medici Code of Ethics, data is normally collected on an individual basis, unless the HCP does not give his or her consent to the processing of personal data. In the latter case, data will be published on an aggregate basis.

The Italian Parliament is currently discussing a legislative proposal (Senate Act No. 1201 that is under consideration by the Hygiene and Health Commission) to strengthen the disclosure obligations of companies of the healthcare industry (see Section VIII).

VI SPECIAL LIABILITY OR COMPENSATION SYSTEMS

The compensation system in the life sciences sector makes no exception from the ordinary rules of the Italian Civil Code on tort liability (Sections 2043 and 2050) and the Italian Consumer Code, regulating damage caused by defective products. Specific provisions of law apply to compensation due to persons injured by mandatory or recommended vaccinations under Law No. 299/2005.

Moreover, the law requires mandatory insurance for HCOs and HCPs as well as for sponsors of clinical trials.

VII TRANSACTIONAL AND COMPETITION ISSUES

i Competition law

The report of the European Commission on competition enforcement in the pharma sector, published on 28 January 2019, states that in the period 2009–2017 the Italian Competition Authority (ICA) was the most active authority within the EU, having issued pecuniary sanctions to pharma companies totalling €198.5 million.

The most recent landmark decisions of the ICA in the pharma sector focus on abusive conducts and anticompetitive agreements.

In 2014, in the Lucentis Avastin case, the Italian ICA sanctioned Hoffmann-La Roche and Novartis with a pecuniary fine amounting to €90.6 million and €92 million respectively, as they entered into an anticompetitive agreement aimed at discouraging and limit off-label use of Hoffmann-La Roche's oncology medicine – Avastin for treatment of age-related macular degeneration. According to the ICA, the arrangement was intended to disseminate information raising concerns about the safety of Avastin used in ophthalmology to shift demand towards the more expensive Lucentis. The decision of the ICA was confirmed by the Council of State with its decision No. 4990 dated 15 July 2019.

In the Aspen case in September 2016, the ICA imposed a €5.2 million fine on Aspen for abusing its dominant position by setting unfair prices for important off-patent medicines used to treat cancer. The ICA found that Aspen abused its dominant position in Italy by threatening to initiate supply termination, imposing price increases of between 300 and 1,500 per cent and by applying particularly aggressive tactics towards the AIFA in negotiating these prices. The ICA decision was upheld by the Administrative Regional Court of Rome. An appeal against this judgment is pending before the Italian State Council.

ii Transactional issues

In mergers, acquisitions and corporate transactions concerning life science companies, various specific industry-related issues should be taken into consideration. Among others, from a transactional standpoint specific attention should be paid to transfers of MAs of medicines and CE marks, assignment of contracts with public entities as a result of the transaction, transfer of pending clinical trials and accomplishment of payback obligations. The above issues require interactions with public entities, which in some cases must issue a specific authorisation.

VIII CURRENT DEVELOPMENTS

The most recent changes in legislation relate to the clinical trial sector, where Legislative Decree 52/2019 has implemented Delegation Law No. 3/2018 (see Section II.iii).

Parliament is currently discussing a legislative proposal to strengthen the disclosure obligations of companies in the healthcare industry. In particular, this proposal provides for the disclosure on a public telematic register called 'Transparent Health' of agreements and transfers of money, goods, services or other utilities made by a manufacturing company in favour of HCPs and HCOs.

Finally, a decree establishing new criteria and procedures for price negotiation of medicines reimbursed by the NHS is expected to be published in 2020 (see Section III).


Footnotes

1 Roberto Cursano is a partner, Riccardo Ovidi is an associate and Irene Carlet is a legal trainee at Studio Professionale Associato a Baker & McKenzie.