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Trends and developments

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?

In recent years, the Italian authorities have focused mainly on cost containment and other financial measures to control public pharmaceutical expenditure, especially with regard to expensive innovative medicines, oncological products and orphan drugs. This trend has led to a range of measures which make the reimbursement framework a challenging one.

In addition, the Anti-competition Authority is becoming increasingly interested in the pharmaceutical sector, especially product pricing.

Legal framework

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The primary legislation governing medicinal products in Italy is Legislative Decree 219/2006 (the Medicinal Product Code), as amended from time to time, which implemented the EU Medicinal Products Directive (2001/83/EC).

Other relevant laws include:

  • Legislative Decree 211/2003 on clinical trials, which implemented the EU Clinical Trials Directive (2001/20/EC) and following amendments including Leg. Decree 200/2007;
  • Legislative Decree 206/2005 on the Consumer Code;
  • Legislative Decree 269/2003, which established the Italian Medicines Agency (AIFA) and addressed certain aspects of the pricing and reimbursement system; and
  • Legislative Decree 196/2003 on data protection (soon to be replaced by EU Reg. 679/2016 (“GDPR”) and the implementing national legislation).

Are any legislative changes proposed or expected in the near future?

With reference to data protection, GDPR will become enforceable from 25th May 2018 and a bill of law is currently under Parliament’s scrutiny in order to implement the necessary changes. With reference to clinical trials, in view of the EU Reg. 536/2014, Italy has undertaken steps towards a simplified and more centralized authorization procedure of clinical trials. Parliament has recently delegated the Government to adopt a new legislation concerning, inter alia: a cut to the number of Ethic Committees (from nearly 90 to 40); the setup of a supervising national body on ECs’ activity; enhanced transparency and anti-conflict of interest rules of EC’ members; simplified trial authorization procedures; involvement of patients association in the authorization process. A landmark change is also expected in relation to no-profit clinical trials, as the new law should allow the use of the trial results for commercial and/or registrative purposes against the reimbursement by the pharmaceutical company of all incurred costs and expenses.

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

The AIFA is the competent regulatory authority entrusted with :

  • product authorisation and manufacturing authorisation;
  • price and reimbursement negotiation;
  • market surveillance;
  • pharmacovigilance;
  • enforcement; and
  • authorisation of clinical trials.

The AIFA is an independent body operating under the auspices of the Ministry of Health and the Ministry of Finance and Economic Development.

The Ministry of Health maintains specific competences regarding medicinal products, including with regard to:

  • the authorisation of ads targeted at the public;
  • psychotropic product and drug matters; and
  • the medicinal product traceability system.

Are any other legal regimes applicable to the trade of medicinal products (e.g., competition, international trade, data protection, consumer protection)?

The laws and regulations that govern medicinal products must be read and interpreted in connection with a range of other laws, including administrative, commercial and contract law as well as the laws concerning competition, data protection and product safety and liability.

Are any medicinal products exempt from regulation (e.g., complementary and alternative medicines)?

Some categories of medicinal product are excluded, in whole or in part, from the Medicinal Product Code’s scope of application, including:

  • investigational products (partially, as certain provisions on manufacturing apply);
  • extemporaneous preparations;
  • magisterial preparations;
  • intermediate products (partially, as certain provisions on manufacturing apply);
  • blood and plasma (unless when preparation involves an industrial process); and
  • radionuclides in the form of sealed sources.

Conversely, homeopathic and herbal medicines fall within the code’s scope.

Supply

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

All manufacturing operations, including the manufacturing of active pharmaceutical ingredients, must be carried out in duly authorised plants pursuant to Article 50ff of Legislative Decree 219/2006 (the Medicinal Product Code) i.e. Articles 40ff of the EU Medicinal Products Directive (2001/83/EC). The Italian Medicines Agency (AIFA) grants authorisation after due inspection to ensure compliance with good manufacturing practices (GMPs). A manufacturing licence and GMP certificate will be issued in accordance with EU requirements, including the European Medicines Agency’s Interpretation of the Union Format for Manufacturer/Importer Authorisation. The authorisation procedure takes 90 days.

What is the fee for obtaining authorisation?

The fee for obtaining manufacturing authorisation for the first time is approximately Euro 14,500. Lower fees apply to the manufacturing of medicinal gases and active pharmaceutical ingredients.

What is the validity period for authorisation?

Manufacturing authorisation is granted for an indefinite period, while GMP certificates have a duration of approximately three years, although AIFA may grant a longer duration based on the risk assessment performed during inspections.

How robust are the standard good manufacturing practices followed in your jurisdiction?

The AIFA ensures GMP compliance by conducting regular manufacturing site inspections when issuing or renewing GMP certificates. The AIFA is active in this field; between 2012 and 2014 it conducted more than 2,500 inspections.

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

Penalties vary depending on the type of violation. For example, failure to obtain manufacturing authorisation is a criminal offence punishable by six to 12 months’ imprisonment and a pecuniary fine of between €10,000 and €100,000. The same penalties apply to continuing manufacturing operations where the party fails to maintain any of the mandatory requirements (e.g., employing a qualified person or having suitable equipment). Similar penalties apply to any party that distributes or markets medicinal products which have been manufactured in non-authorised or non-compliant plants.

Administrative fines are provided in case a manufacturer fails to comply with any recommendation or remedy plan suggested by the AIFA after an inspection. 

Distribution

How are the distribution and storage of medicinal products regulated?

A wholesale licence is required for the storage and wholesale of medicinal products. Authorisation is granted by the regional health authority competent for the territory where the warehouse is located. The same authorisation is also required for storage on behalf of the marketing authorisation holder. The wholesale licence holder must ensure that it complies with the GMPs.

Wholesalers are considered to perform a public service and must ensure that the territory of competence is duly covered and adequately supplied. This has become a priority in regulatory authority enforcement actions aimed at preventing the increasingly frequent issue of shortages due to parallel exportation.

Italian wholesalers are bound to a minimum stock obligation and mandatory timelines for ensuring supply to retailers.

Specific precautions must be taken by pharmacists that concurrently undertake wholesale activities.

Import and export

How are the import and export of medicinal products regulated?

Under Article 55 of the Medicinal Product Code, the code’s provisions relating to manufacturing authorisation also apply to imports from other EU member states. Following the changes introduced by the EU Falsified Medicines Directive (2011/62/EC), importation authorisation is not required for products transiting through Italy with the sole purpose of exportation.

The importation of products authorised outside of Italy is permitted under the strict conditions of the Ministerial Decree of February 11 1997 and is therefore permitted only where it will meet a patient’s special needs lacking an authorized therapeutic alternative. A request for such importation must be made by the physician under his or her own direct liability and the imported quantities cannot exceed 90 days’ worth of treatment. Interestingly, the MoH Circular note issued on 23rd March 2017 ha provided a broad interpretation of “existing therapeutic alternative” including, inter alia, the case where an authorized product exists but either the patient is not eligible for reimbursement or the product is too expensive.

Conversely, exportation requires no specific authorisation or licence. Upon request, the AIFA may issue a free sale or pharmaceutical product certificate (CPP).

Are parallel imports permitted in your jurisdiction?

Parallel imports are addressed in the Ministerial Decree of August 29 1997; the EU Commission’s communication of December 30 2003 provides further guidance on this matter.

Parallel importation requires specific authorisation from the AIFA. To obtain authorisation, the importer must provide the AIFA with a copy of the packaging and labelling in Italian, as well as a product sample. Further, it must declare that the imported product has the same composition and indications as the corresponding product marketed in Italy.

As regards IP rights, Italy abides by the principles concerning repackaging and relabelling established at EU level by the European Court of Justice. The Italian courts generally rule in favour of trademark owners and give a strict interpretation of the requirement of recurring objective causes which justify repackaging.

Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

At the retail level, the sale of medicinal products to the public is a statutory prerogative of pharmacies (Article 122 of Royal Decree 1265/1934) and, in the case of over-the-counter and non-prescription products, para-pharmacies (Article 5(1) of Decree Law 233/2006, implemented by Decree-Law 248/2006). Over-the-counter medicines can also be sold in dedicated areas of large-scale distribution retail centres, provided that:

  • certain structural requirements are met; and
  • they are sold under a pharmacist’s surveillance.

Hospitals may implement alternative delivery systems for supplying out-patients in order to ensure the continuity of therapy. Such systems may involve:

  • pick-up points located on hospital premises;
  • ad hoc structures (i.e., direct distribution systems); or
  • community pharmacies which dispense medicinal products on behalf of the hospital (ie, a distribution-on-behalf-of system).

Are there any restrictions on the online sale and purchase of medicinal products?

Italy transposed the EU Falsified Medicines Directive (2011/62/EC) in 2014, but did not implement the regulations for another two years. As such, the online sale of medicinal products has been effective since January 2016 and remains to be fine-tuned.

By law, the online sale of medicinal products is limited to non-prescription medicines. There are also subjective requirements to be considered – in particular, a mail-order business can be operated only by a pharmacy or para-pharmacy. Wholesalers are explicitly prohibited from undertaking this type of activity. Further, the regulation’s wording seems to link online businesses to physical businesses, which means that pharmacies and para-pharmacies can sell medicines via mail order only if they operate a bricks-and-mortar pharmacy/para-pharmacy.

Named patient supply

What rules govern named patient supply of pre-launch medicinal products?

Various legal grounds enable named patient supply. Under the first scenario, Article 5(1) of the Medicinal Product Code, reflecting Article 5 of the EU Medicinal Products Directive (2001/83/EC), and Article 5 of Decree-Law 23/1998, implemented by Decree-Law 94/1998, allow named patient supply of unauthorised medicinal products, industrially prepared, supplied in response to a bona fide unsolicited written order from a physician to fulfil a patient’s special needs. ‘Special needs’ is interpreted by the Italian authorities to mean that no suitable authorised product is available on the domestic market. The rules concerning magisterial preparation apply.

On a different level, at the end of 2017, a major change in the law occurred in relation to compassionate use. Ministerial Decree 7 September 2017 has broadened the definition of compassionate use (CU) which now include:

(i) use of investigational products either (a) on a named patient basis for patients who were not enrolled in the trial; or (b) for patients who were in the trial and the trial results has showed tolerability, safeness and efficacy profiles sufficiently sound to support a decision of therapeutic continuity after the end of the trial;

(Ii) off-label use of authorized products;

(iIi) use of authorized products “not available on the market”, which means, as clarified by AIFA in a Q&A document, products which are not yet commercialized or for which there is a shortage due to unforeseeable reasons and for a limited period of time.

Case under (iii) raises a number of serious issues, especially in relation to the timing of the launch of a product. In Italy, highly costly products are usually launched only after the P&R negotiation is concluded as hospitals could not afford a purchase at the full, not negotiated price (launch in C-nn class). In addition, it is worth mentioning that the local hospital can purchase the product only after a further reimbursement procedure is carried out at regional/local level. The whole process may take months or, in the worst case, years. Timing can therefore become a critical elements when evaluating a CU program or request.

Prior requirements are:

  • lack of alternative therapeutic alternative;
  • the patient shall be affected by a rare or seriously debilitating or life-threatening disease and they cannot be enrolled in a clinical trial or there is the need to ensure therapeutic continuity after the end of a trial;
  • the product’s intended use is supported by Phase III or, in case of life-threatening conditions, Phase II study results. In case of rare diseases, rare cancer or serious conditions, phase I study results are sufficient;
  • there has been an unsolicited request by a physician, who takes direct and personal responsibility for the product’s use;
  • the relevant ethics committee has approved the protocol of use, which must also be sent to AIFA which retains a veto power; and
  • the product is supplied by the company free of charge.

Another legal ground for gaining access to unlicensed medicines/unlicensed use of authorized medicines – not on a named patient basis, rather as systematic use approved by AIFA and reimbursed by the NHS – is provided by Article 1(4) of Decree-Law 536/1996, passed into law by Law 648/1996 (“648 List”). This ground applies to products that:

  • are unauthorised in Italy, but have a foreign marketing authorisation;
  • are undergoing clinical trials; or
  • shall be used off label

Until 2014, an essential prior requirement was the lack of a reimbursed, approved treatment. Since 2014, the inclusion in the 648 List may also occur despite the existence of an authorized therapeutic alternative, when such use allows significant savings for the NHS.

Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

Until the new regulation comes into force and the bill of law currently under the scrutiny of the Italian Parliament is approved, authorisation of clinical trials is regulated by Legislative Decree 211/2003, and following amendments. This is a two-step procedure, in which the two phases run in parallel. The competent authority for all clinical trials from Phases I to IV is the Italian Medicines Agency (AIFA), which retains vetting power for 60 days from notification. Documents must comply with the requirements set out in the Ministerial Decree of December 21 2007 and be submitted through the National Monitoring Centre of Clinical Trials’ database.

At the local level, the trial must be authorised by the ethics committee competent for the concerned trial site.

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

The AIFA, the competent authority for enforcement actions in clinical trials, conducts thorough trial site inspections, including inspections of aspects relating to the implementation of and compliance with the good clinical practices.

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

The Ministerial Decrees of May 12 2006 and February 8 2013 concerning the requirements of ethics committees state that a trial’s protocol must guarantee the investigators’ right to disseminate and publish the results without prejudice of the confidential information and data protection provisions. The protocol must also expressly set out the sponsor’s commitment to publishing the trial results, regardless of whether they are positive.

Similarly, clinical trial agreements usually contain provisions that allow investigators to publish data collected at their site if, after a certain period (usually between one to two years from the study’s conclusion), the sponsor has not done so in full.

The AIFA shares the European Medicines Agency’s policy on the transparency and disclosure of clinical trial data contained in the marketing authorisation dossier once the product has been authorised. 

What are the informed consent obligations with respect to clinical trial subjects?

Clinical trial subjects must be given full, thorough and clear information about the trial in order to assess the risks and benefits of their participation. The language must be relatively easy for a layperson to understand and the subject must be given extensive time to consider the trial and seek any necessary clarifications or assurances.

To obtain informed consent, subjects must receive all potentially relevant information, including with regard to:

  • the benefits and risks of the treatment;
  • how their confidentiality and privacy will be protected;
  • how their biological samples will be used, stored and destroyed;
  • insurance coverage;
  • their right to withdraw from the study; and
  • the consequences in terms of the data and samples collected.

In case of minors or incapacitated persons, consent must be given by an authorised representative. 

Insurance

What are the insurance requirements for clinical trials?

Insurance requirements are set out in the Ministerial Decree of July 14 2009. Insurance must cover the civil liability of all subjects involved in the clinical trial – as well as that of the sponsor, site and investigator – for any damage suffered by subjects arising from the study. In particular, insurance must cover damages (eg, death and injury, as well as direct economic loss) arising from negligence or professional misconduct on the part of the investigator, as well as any unintentional damages that the investigator may cause.

The maximum coverage should be no less than €1 million for each trial subject and no less than the prescribed thresholds for each clinical trial protocol, depending on the number of enrolled patients.

If the insurance policy provides for a franchise, it cannot be enforced against the trial subject.

Data protection

What data protection issues should be considered when conducting clinical trials?

In 2008 the Data Protection Authority clarified by way of its Guidelines on Clinical Trials that trial patients’ coded data is not anonymous. Rather, it is ‘de-identified’ data as, in exceptional circumstances, the sponsor can undertake a re-identification process. Therefore, the sponsor and clinical trial site are both considered to be data co-holders, while the contract research organisation and the investigator act are data processors. Such qualification will be particularly sensitive under the GDPR.

Specific information must be provided where genetic data will be processed.

At the date of publication of this article, there are no specific guidance by the Italian Privacy Authority about GDPR and clinical trials.

Marketing authorisation

Authorisation

What is the marketing authorisation procedure for medicinal products in your jurisdiction?

A medicinal product can be authorised by the Italian Medicines Agency (AIFA) by way of a national mutual recognition or decentralised procedure. The application can be filed under the full standard application, or an abridged application can be filed for generic, hybrid or biosimilar products or in the other cases provided for by Articles 11 and 12 of Legislative Decree 219/2006 (the Medicinal Product Code). In this regard, the code mirrors Articles 8 and 10 of the EU Medicinal Products Directive (2001/83/EC).

What criteria are considered in granting marketing authorisation?

The requirements for obtaining marketing authorisation are set out in Article 8 of the EU Medicinal Products Directive (2001/83/EC). In general, applicants must provide all of the information and documentation necessary to support the efficacy and safeness of the product, including:

  • its qualitative and quantitative composition;
  • pharmaceutical test and pre-clinical and clinical trial results;
  • information about the manufacturing process and compliance with the good manufacturing practices;
  • a summary of the applicant’s pharmacovigilance system;
  • a summary of the product’s characteristics; and
  • a mock-up of the product’s packaging.

What is the fee for obtaining marketing authorisation?

Fees for a new marketing authorisation may vary between € 64,000 and € 76,000 (depending on the type of authorization procedure) which covers one dosage and one pharmaceutical form and presentation.

What is the validity period for marketing authorisation?

A marketing authorisation is valid for five years from first issuance (i.e., publication of the AIFA decree in the Official Gazette). After the first renewal, the authorisation will have open-ended validity, unless it is decided for pharmacovigilance reasons that the authorisation will be subject to a limited renewal for a further five years.

Marketing authorisation is subject to a ‘sunset’ clause (i.e., it elapses if the product is not marketed for more than three years).

What are the consequences of failure to obtain marketing authorisation?

It is a criminal offence to place on the market a medicinal product that has:

  • no marketing authorisation;
  • a suspended or revoked marketing authorisation; or
  • a different composition to the one that was authorised.

The above offences are punishable by one year’s imprisonment and a pecuniary fine ranging from €2,000 to €10,000.

A wide range of administrative penalties apply in the event that a product is not marketed in compliance with the authorised product characteristics (eg, with regard to the summary of product characteristics or labelling).

Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

A marketing authorisation holder must maintain a positive risk-benefit ratio for authorised medicinal products at all times, in compliance with the pharmacovigilance obligations set out in Title XI of Legislative Decree 219/2006 (the Medicinal Product Code), which mirrors Title IX of the EU Medicinal Products Directive (2001/83/EC), as amended in 2010 and 2012.

The person responsible for pharmacovigilance must meet certain subjective requirements with regard to education and qualification.

The marketing authorisation holder must submit periodic reports on product safeness (PSURs) through the European Medicine Agency’s PSUR repository:

  • every six months during the first two years of authorisation;
  • once per year in the following two years; and
  • every three years subsequently.

PSURs are not required for generic, homeopathic and traditional herbal medicinal products or products based on active substances which have a well-established medicinal use.

PSUR data, along with spontaneous adverse drug reaction data, is collected through the National Network of Pharmacovigilance (RNF), an extensive national network that includes regional authorities, regional centres of pharmacovigilance, local health authorities, hospitals, research institutes, pharmaceutical companies and the AIFA.

The RNF operates in close connection with EudraVigilance, the European network for pharmacovigilance.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

In pharmacovigilance reports, the patient is not identified by his or her full name, but rather by his or her initials. Some personal information is required (e.g., the patient’s date of birth and ethnicity).

Data protection issues may arise, for example, when adverse reaction reporting is done spontaneously by the patient through the pharma company website. The collection and processing of this data by pharmaceutical companies is necessary in order to fulfil the mandatory obligation set out in Article 24 of the Data Protection Code, which constitutes a case where consent is not required. Conversely, patients must be given the minimum information required under Articles 7 and 13 of the Data Protection Code (e.g., the data holder’s name, the type of data to be collected, the type of processing operation and the patient’s right to modification, rectification and cancellation).

Pricing and reimbursement

Pricing

Are there rules governing the pricing of medicinal products in your jurisdiction?

Price negotiation is mandatory for medicinal products that are intended to treat life-threatening chronic diseases or essential to guarantee the fundamental level of healthcare (so-called ‘Class A’ medicinal products). Class A products are reimbursed by the National Health Service (NHS). On the contrary, manufacturers are free to set the price of non-reimbursed products (so-called ‘Class C’ products). Since 2012, pharmacists have been free to set the price of over-the-counter products.

Price and reimbursement conditions are negotiated by way of the same negotiation procedure before the Italian Medicines Agency (AIFA). The applicable procedure and criteria are set out in Article 48 of Law 326/2003 and Resolution 3/2001 of the Interministerial Committee for Economic Planning.

In general terms, price is determined by assessing, among other things:

  • the product’s cost-effectiveness ratio compared with other available treatments;
  • evidence pertaining to the product’s clinical superiority or non-inferiority;
  • the product’s average international price (although Italy does not apply a proper international reference price criterion);
  • 24 months’ of expected sales; and
  • the expected impact on NHS expenditure.

Managed entry schemes are becoming increasingly more frequent.

Negotiations should be concluded within 180 days, but this term is not mandatory. Orphan drugs and drugs “having an exceptional therapeutic and social relevance” (Article 12(3) of Decree-Law 158/2012) are subject to a fast-tracked procedure in which the pricing and reimbursement negotiations should be carried out within 100 days. While the negotiations are pending, products approved centrally or via a mutual recognition or decentralised procedure are automatically classified in Class C-nn (non-negotiated), which means that they can be sold at a price freely set by the manufacturer.

A pricing and reimbursement agreement is valid for 24 months and renewable for a further 24 months unless one of the parties requests a renegotiation at least 90 days before the first term expires. Renegotiation can also be requested during the first 24 months in the case of a modification of the therapeutic indications or dosage which may lead to an increase in the product’s consumption.

Reimbursement

What is the structure for state reimbursement of medicinal product costs?

A medicinal product’s reimbursement status is granted at the national level by the AIFA. The reimbursed products are included in the National Pharmaceutical Guidebook, which comprises a list of all products reimbursed by the NHS. The AIFA may further limit reimbursement of a product included in the guidebook – for example, to specific indications or patient populations or care facilities – by issuing a so-called ‘limitative note’.

Regional authorities have concurrent powers to manage local healthcare expenditure and may further limit a product’s reimbursement status, considering local patients’ needs and the region’s financial situation. Every region implements a Regional Therapeutic Formulary – a list of reimbursable drugs at the regional level. Regional authorities can decide the partial or total exclusion of Class A medicinal products from reimbursement, based on the region’s pharmaceutical expenditure and planned expenditure limits. However, any decision about reimbursement made by the regional authorities must rely on the technical assessment of the therapeutic equivalence of products made at the national level by the AIFA. 

Only the AIFA has the authority to determine whether two products, based on different active substances, are therapeutically equivalent. This scientific assessment is the legal basis for local payers (ie, regional authorities and hospitals) to exclude products which are therapeutically equivalent to others already included in the Regional Therapeutic Formulary from local reimbursement schemes.

As regards originator and generic products, co-payment mechanisms exist.

Finally, it is worth-mentioning that on 27th March 2018 AIFA issued a new Position Paper concerning biosimilars which allows interchangeability between the biological product and its biosimilars under the physician’s supervision (remaining that automatic substitution is prohibited by law) not only for naïve patients but also patients in course of treatment. Physicians are also made to some extent responsible for the decision to prescribe the more expensive product (the originator).

Advertising and labelling

Advertising

How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?

The advertising of medicinal products is governed by Articles 113 to 128 of Legislative Decree 219/2006 (the Medicinal Product Code) and the guidelines issued by AIFA in 2010 with reference to OTC, medical devices and veterinary products and in 2017 concerning online promotion of OTC. At the industry association level, the Farmindustria Code provides further guidance on the advertising and promotion of medicinal products. As a general rule, only over-the-counter medicinal products can be advertised to the public and any material must be approved in advance by the Ministry of Health. Messages are considered approved if an express denial is not issued by the Italian Ministry of Health within 45 days from the filing date. Prescription products can be promoted only to the healthcare professionals who can prescribe the concerned product. Materials for HCPs must be filed with the Italian Medicines Agency (AIFA) at least 10 days in advance. Promotion directed at healthcare professionals must contain, at a minimum:

  • the approved summary of product characteristics;
  • the product’s classification for supply and reimbursement purposes; and
  • the product’s price.

Alternatively, promotions can also be limited to the product brand and active substance’s name.

Do any special rules apply to online advertising of medicinal products?

Online promotional materials follow the abovementioned authorisation procedure; authorization shall be requested for each banner, webpage, frame as each of them is considered a distinct advertisement tool. In case of prescription medicines, promotion is permitted on a webpage with restricted access for healthcare professionals.

Specific Guidelines have been issued by the MoH with reference to advertisement of OTC on social media such as Facebook, Instagram and Youtube. For example, as far as Facebook is concerned, advertisement is not allowed on the company’s institutional page; then, promotional messages can be posted on the wall insofar the “comment” or “like” function is disabled, while a specific disclaimer must be inserted in relation to possible post-sharing by users. On the right column near the wall, the company may publish advertisement redirecting the user to an external webpage.

Similar rules apply to Youtube: therefore, promotional videos can be published provided that comments are disabled along with the functions for counting the number of likes or embedding the video. Pre-roll video advertisement are allowed.

Finally, on Instagram it is only possible to publish promotional videos or messages in the stories, as users cannot comment on those.

Labelling

What are the packaging and labelling requirements for medicinal products?

Labelling must contain all of the elements required by Article 73 of the Medicinal Product Code. The summary of product characteristics must appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging. Among other things, the outer packaging must bear the product’s name and special warnings, which must also be included in Braille. Article 73 also establishes specific rules regarding the labelling of medicinal products containing radionuclides, radiopharmaceuticals and homeopathic medicines. “Bollino” is also another essential element of the outer packaging aimed at ensuring proper traceability of the product (not to be confused with the safety features pursuant to the Falsified Medicines Directive).

How is the promotion of off-label use regulated?

The promotion of off-label use is forbidden under Articles 113 and 114 of the Medicinal Product Code.

Relations with healthcare professionals

Gifts and incentives

What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?

In the worst case scenario, the provision of an undue incentive to healthcare professionals and pharmacists in order to encourage the prescription or sale of a medicinal product may constitute a crime – specifically, a form of bribery known as ‘comparaggio’ (i.e., when a doctor accepts money to prescribe a particular medical product).

Provision of gifts, discounts and other incentives of non-negligible value to healthcare professionals within the scientific-information activity may also constitute illicit behaviour under Article 123 of Legislative Decree 219/2006 (the Medicinal Product Code) and be subject to penalties under Article 147(5). The Farmindustria Code sets the threshold of negligible value at €25.

Liability

Defect products

How can a liability claim for a defective medicinal product be brought?

A manufacturer may be liable for a medicinal product:

  • under Legislative Decree 206/2005 (the Consumer Code), which implemented the EU Product Liability Directive (85/374/EEC);
  • under tort law (i.e., Article 2055 of the Civil Code); and
  • to a limited extent, under contract law.

Which parties can be held liable for a defective medicinal product?

Both the manufacturer and the marketing authorisation holder can be held liable for a defective medicinal product. Article 39 of Legislative Decree 219/2006 (the Medicinal Product Code) provides that the manufacturing licence or marketing authorisation does not exempt the manufacturer and marketing authorisation holder from liability.

Remedies

What remedies are available to successful claimants?

Remedies include monetary compensation and injunctive relief. Legislative Decree 206/2005 (the Consumer Code) provides that recoverable damages are those resulting from death or personal injury.

If the claimant is suing under tort law, recoverable damages include material and non-material damages (e.g., moral and biological damages). If the claimant is suing under contract law, recoverable damages resulting from breach of contract include actual incurred damage and loss of profits.

Exclusion and limitation

On what grounds can liability be excluded?

Under the Consumer Code, the defendant can invoke exclusion from liability by proving that:

  • the producer did not circulate the product;
  • the defect did not exist when the manufacturer placed the product on the market;
  • the manufacturer did not manufacture the product for sale or any other form of distribution against consideration;
  • the defect depends on the product’s compliance with mandatory regulations or binding measures;
  • the scientific and technical knowledge available at the time of circulating the product did not allow it to be considered defective;
  • the manufacturer of a component fully complied with the instructions given by the manufacturer; and
  • the defect is entirely attributable to the design of the final product in which the component has been incorporated.

However, under the Consumer Code, a producer may be held liable only if the product is defective in relation to its ordinary intended use. The producer cannot be considered liable when the injured person, although aware of the product’s defect and the deriving risk, voluntarily exposed himself or herself to such a risk. Similarly, no damages can be awarded if the injured person could have avoided the injury by acting with ordinary diligence and duty of care.

Compliance with existing rules is insufficient to exclude tort or contractual liability if the agent is found to have acted with negligence, imprudence or lack of skill. If the activity undertaken by the producer is considered to be dangerous, the producer is free from liability if it can be demonstrated that it adopted all possible measures to avoid the damage.

The limitation period for bringing product liability claims depend on the legal basis invoked by the plaintiff:

  • Under the Consumer Code, consumers can file an action against the producer within three years from when they become (or should reasonably have become) aware of the damage, the product defect and the identity of the producer. In any case, the action must be brought within 10 years of the product first being placed on the market by the manufacturer (or EU importer).
  • Under tort law, the plaintiff can bring an action within five years.
  • Under contract law, the plaintiff can bring an action within 10 years.

What preventive steps can be taken to limit liability?

In Italy, the manufacturing of medicinal products qualifies as a dangerous activity. Therefore, producers are exempted from liability when they can demonstrate that they adopted all possible measures to avoid the damage.

Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

The competent authorities for enforcing the laws governing medicinal products are the Agency for Medicinal Products (AIFA) and the Ministry of Health, both of which are entrusted with a wide range of enforcement powers relevant to their own areas of competence, including:

  • undertaking inspections and audits;
  • suspending and revoking authorisations; and
  • issuing interdictory or pecuniary penalties.

Inspections may be conducted through the police body specialised in health-related matters (NAS). Since 2017, the AIFA has a dedicated NAS unit. Regions and hospital units also have parallel enforcement powers concerning, for example, wholesale activities or pharmacies.

On January 19 2017 the AIFA signed a memorandum of understanding with the Anti-competition Authority in order to increase cooperation and enforcement in the pharmaceutical sector by facilitating the exchange of information and data – for example, with reference to suspected abusive behaviours in price and reimbursement negotiations or counterfeiting cases. Further, the authorities will cooperate in carrying out sector enquiries.

At the industry level, the self-governing industry association Farmindustria has enforcement and sanctioning powers over affiliated companies in relation to Ethics Code compliance.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

From a company perspective, it is good standard practice to implement an organisational model and ethics code, as well as standard operating procedures, in order to prevent employees from committing crimes. Under Legislative Decree 231/2001 regarding the administrative liability of companies for crimes committed by their employees, a company may be exempted from liability if it provides sufficient evidence that it adopted adequate measures to prevent the commission of crimes by its employees.

Farmindustria has provided guidelines on how to establish a proper organisational model in the pharmaceutical industry, especially with regard to sensitive areas, such as interactions with healthcare professionals and public institutions and rewarding mechanisms for agents operating in the field.

Healthcare organisations must abide by Legislative Decree 190/2012 and enforcing Decree 33/2013, which aim to ensure transparency among public bodies and prevent corruption and bribery by implementing a number of long-waited measures in Italy (eg, with regard to whistleblower protection). In particular, each public body (eg, public hospitals) must adopt specific prevention measures, including:

  • the adoption of an anti-corruption plan;
  • the appointment of a compliance officer; and
  • the adoption of an employee code of conduct.