| Home

16 Nov 2006
Global Counsel 2007
Francesco Setti

Regulatory overview
1.
Please give a broad overview of the structure and funding of the national healthcare system.
The National Health Care System (NHS) is made of several institutional bodies, both at national and territorial level, which mutually coordinate their activities within their specific areas of competence. In particular:

at national level: the most important institutions are Ministry of Health (MoH) and the Higher Health Council.
at territorial level: Regions and Self-governing Provinces of Trento e Bolzano; Local Health Units (ASL); Hospitals.
Regions and Self-governing Provinces program and organize all the services provided in their territories and coordinate the action of ASL checking their work.

The NHS is centrally funded by the government throughout the system of the “National Income Taxes”. No participation of the citizens to the Health public expenditure is in force at the moment.
Please briefly describe the regulatory environment for medicinal products/pharmaceutical products/drugs, by whatever name known (referred to below as medicinal products).

The Italian market is basically regulated by Legislative Decree No. 219 of April 24th 2006, implementing the European Directive 2001/83/EC on the Community Code relating to medicinal products for human use and Directive 2003/94/EC.

The Community Code repeals and replaces almost all the former pharmaceutical legislation, exception made for those provisions relating to the price and the listing of the medicinal products paid by the Italian National Health Care System.

It must be pointed out that since 2004 (D.L. September 30, 2003, n. 269), a new Agency on medicinal products (AIFA), replacing the former Commissione Unica del Farmaco (CUF), has been set up. The Agency is self-governed although it operates under the directives and the surveillance of the MoH. The Agency was empowered with several and importance prerogatives and authorities in many different fields that are:

Marketing Authorisations: AIFA is the competent Authority for granting national MAs.

Pharmaco-surveillance: AIFA carries out permanent pharmaco-surveillance activities, among which the keeping and updating the national data base on reverse reaction of products, linked to the European data base (EUDRA vigilance);

Clinical trials: AIFA enforces the National end European provisions on Clinical Trials and coordinates with the National Observatory on Clinical Trials..

Inspection: AIFA inspect the establishment of Pharmaceutical Companies in order to check the respect of quality standards of the products and raw materials. It also assures the respect and the compliance with the National and European legislation.

Information: AIFA provides public and free information in order to promote a rightful use of medicinal products and to guide the therapeutic decisions. It also undertakes updating activities addressed to practitioners, by press and distance-training programs (FAD).

Research Promotion: AIFA promotes comparative no-profit clinical trials in order to prove that new medicinal products are therapeutically more effective than those available on the market. To this purpose, a specific fund has been established, made by 5% of the investment of the pharmaceutical companies in promotional activities

Pharmaceutical expenditure: AIFA contributes to the respect of the budgetary expenditure, by means of a periodic revision of a list of reimbursable drugs, and the bargaining of the prices of medicinal products. By the National Observatory over the use of medicinal products (OsMED), AIFA monitors the national, regional and local drug expenditure as well as drug consumption, and monthly passes on the relevant data to the Regions.

Manufacture and clinical trials
2.
Is authorisation required to manufacture medicinal products? If so, please give an overview of the authorisation process, in particular:
· To whom should the application be made?
· What criteria need to be satisfied to obtain authorisation?
· Are there any specific restrictions on foreign applicants?
· What are the key stages and timing of the process?
· What fee is payable?
· Is authorisation given for a fixed period? If so, for how long and what is the renewal procedure?
An authorisation for manufacturing any kind of drug is required.

Application. Setting up an establishment where a complete or partial (such as incapsulation or packaging) cycle of manufacturing operations is performed, requires an authorisation granted by AIFA. The authorisation is necessary even if the manufacturing is carried out only for export purposes.

Criteria. Manufacturers are required to comply with the provisions of the Decree n. 219/2006, implementing also Directive 2003/94/EC on good manufacturing practice for medicinal products (“GMP”). The applicant must show in its application for authorisation that:

· The establishment has appropriately trained personnel.
· The establishment is equipped for the preparation, quality control and storage of the medicinal products according to the GMP.
· The establishment is managed by a technical director who must be an employee having a specific academic degree, preparation and training.

Restrictions on foreign ownership There are no specific restrictions on foreign ownership.

Key stages and timing. If the information on the application is accurate and compliant with the statutory requirements, AIFA, after inspecting the facilities, must grant the authorisation within 90 days from the receipt of the application. If not satisfied with the given documents, AIFA may request for further information on the production facility or prescribe the conditions to make the premises or the equipment suitable for production, setting a period within which such conditions must be satisfied. If authorisation is refused, the applicant must be given reasons.

Fee. Pursuing to Ministerial Decree 24th May 2004, manufacturing fee, in favour of MoH, is about € 12.580,90 for each establishment.

Period of authorisation and renewals. Authorisation for production is granted for an indefinite period of time.

3.
What powers does the regulator have to monitor compliance with manufacturing authorisations? Does it exercise those powers?
AIFA has the following powers:

· To inspect factories and premises where medicines are manufactured and packaged.
· To collect and analyse samples of medicinal products.
· To view copies of documents related to the purpose of the inspection.

Actually inspections are carried out periodically to all and any premises to check the full compliance with GMP and the respect to all manufacturing authorisations.

Inspections can also be requested by EMEA, European Commission or a State member.

4.
In the event of a breach of the terms of a manufacturing authorisation, what are the regulator's powers of enforcement?
Any inspection ends up with a document released by the inspector. Such a document can contain instructions in order to assure the compliance of the production plants with the all the applicable provisions. The manufacturer has to comply with such provisions within the terms established by the inspector. The production can be suspended until the compliance is fully realised.

A manufacturing authorisation may be revoked for:

· Lack of statutory requirements.
· Breach of legal or regulatory duties.
· Deviation from the GMP.
· Failure to inform the regulatory authorities of the substitution of the technical director.
· Refusal to allow an inspection by AIFA.
· Lack of evidence of quality control on starting materials or intermediates.

Except in cases of extreme urgency, orders suspending or revoking an authorisation are only issued after the facts have been noticed the authorisation holder, who may respond within 15 days. Suspension or revocation orders are served on the authorisation holder and published in the Official Gazette.

AIFA is empowered to close a production facility permanently or for the length of the marketing authorisation suspension.

Revocation decisions can be appealed to the Regional Administrative Tribunal (TAR).

5.
Are clinical trials regulated? If so, please give an overview of the necessary consents, authorisations and procedural requirements.
Directive 2001/20/EC on the conduct of clinical trials was implemented by Legislative Decree no. 211/2003 published in the Official Gazette of 9th August, 2003 and came into force on 1st January 2004.

Medical research is only justified if there is a reasonable likelihood that the population in which the research is carried out stand to benefit from the results of the research.

All clinical trials must obtain a clinical trial authorisation before the trial begins.

Applications for authorisation are made by submitting the relevant forms, together with extensive supporting data and a copy of the favourable mandatory advice of the relevant ethics committee, to the competent authority, which is, depending on the characteristics of the trials:

· general director of the structure where the clinical trial is to be conducted; or
· The MoH; or,
· Higher Health Council.

The authorisation is issued within 60 days from receipt of the application.

Local ethical committees have powers of mandatory advice, control and inspection. The central administration reserves the right to double check their findings.

In authorising trials, great attention is given, within the standard operating procedures of the GCP, to insurance liability coverage, as well as the protocol itself and informed consent.

All medicinal products used in the conduct of trials must be manufactured according to GMP.

Clinical trials (including phase IV) must be conducted only in public hospitals, institutes of research, universities, and not in private centres.

Pricing and state funding
6.
How the prices of medicinal products regulated?
In Italy the issues of price and reimbursement are strictly connected.

Since 1st January, 2001, medicinal products have been divided into two classes (A and C):

· Class A includes essential products and those intended for chronic diseases. These are fully reimbursed by the NHS.
· Class C includes other products which do not have the characteristics of Class A. These are not reimbursed.

There is also a sub-class “H”, which means “reimbursable only in hospitals”, i.e. the NHS pays the drug if administered in hospitals, but, if purchased in a pharmacy is not reimbursed.

The matter of price and reimbursement of the proprietary medicines was drastically reformed in 2003 by Law Decree n. 269 of September 30, 2003 (confirmed by subsequent law n. 326 of November 24, 2003).

Price of drugs listed in class C is free but can be raised by the MA holder only every two years and on the other hand it can be lowered at any moment.

The price of class A products is determined by the result of the negotiation between AIFA and the holder of the marketing authorisation, who has to supply a set of documents suitable to prove and/or to show:

A favourable cost/benefit ratio, since the new drug:

· has an innovative therapeutic effect;
· improve the efficacy of the treatment of a disease;
· improve the risk/benefit ratio.

Other relevant elements to the NHS, should the new drug not be superior, from the clinical point of view, to other available drugs.

Further information concerning:

· the marketing of the product in other countries;
· the therapeutic class of the product;
· the market share estimated for the following 24 months;
· the estimated costs for the NHS.

The failure of the negotiation involves the non reimbursement of the product by the NHS.

The agreement has a term of two years and upon the expiration each party may request the re-negotiation (the re-negotiation may be opened even during the term in case of change of indications or posology influencing the utilisation level of the drug).

The price agreed upon is the maximum ex factory price for the NHS (i.e. the base price for the sale to hospitals); the margins for wholesalers and pharmacists are added up according to a scale depending on the level of the ex-factory price, so to reach the public price for those drugs which are to be distributed by pharmacies.

With effect from 1st July, 2001 off-patent products will be reimbursed within the limit of a reference price established at the level of the weighted average price of generic drugs having the same composition and dosage form.

7.
In what circumstances will the cost of a medicinal product be funded or reimbursed by the state? How is pricing determined in these circumstances?
The reimbursement for the proprietary medicines which belong to class A is performed in a direct form (the patient gets the product free of charge and the NHS pays the pharmacies).

Hospitals purchase the products directly from the marketing authorisation holders or manufacturers with a discount of not less than 50% on the public price (products with a negotiated price are not subject to this minimum discount).

Marketing
8.
Is authorisation required to market prescription-only medicinal products? If so, please give an overview of the authorisation process, in particular:

· To whom should the application be made?
· What conditions must be satisfied by the applicant?
· What are the key stages and timing of the process?
· Is there an abridged procedure?
· What fee is payable?
· Is authorisation given for a fixed period? If so, for how long and what is the renewal procedure?

No medicinal products can be put on the market without:

An authorisation from the AIFA (which may be purely national or by mutual recognition); or
An EU authorisation granted by European Agency for the Evaluation of Medicinal Products (EMEA).
The national Marketing Authorisation covers all the medicines (including generics, homeopathics, radiopharmaceutical). The procedure for the mutual recognition and the so called decentralised procedure are ruled by articles from 41 a 49 of Decree 219/2006. Mutual recognition is when the product is already been authorised in a State Member, which becomes the reference State. Decentralised procedure is when the product is not authorised yet, and the evaluation process involves all the relevant States, among which the reference State will be choose. In case of disagreement on the possible risk to public health during the mutual recognition or decentralised procedure, AIFA may temporarily authorise the product, until an arbitration procedure is carried out. Within 30 days from the decision of the European Commission, AIFA must comply accordingly.

Application. The application for a MA shall be submitted to AIFA. There is no need to obtain a marketing authorisation in some very special cases, the most important of which is when a product is prepared in response to an unsolicited request from a practitioner, who undertakes to use such products on patients under his care (“compassionate use”).

Criteria. The application and attached documentation (“drug master-file”) must demonstrate that the product meets the relevant criteria and safety, quality, performance and effectiveness for the product to be marketed accordingly to decree 219/2006.

The assessment of a marketing authorisation application involves the checking of documentation and the abilities of the manufacturer; possible control by the Higher Health Institute over raw materials, intermediates and other constituents of the medicines; and an assessment report by AIFA.

The grant of the marketing authorisation does not shield the manufacturer or the seller of the product from civil or criminal liability. A marketing authorisation will be refused when the application and its supporting documents, and investigations carried out by the MoH or AIFA, show that:

· The medicines is harmful under normal conditions of use.
· It does not have the quantitative or qualitative composition stated in the application.
· It does not have any therapeutic effect or the therapeutic effect has not been sufficiently demonstrated by the applicant.
· The application and attached documentation do not conform to the marketing authorisation's provisions.

Key stages and timing. The marketing authorisation must be granted or denied within 210 days from the filing of the application. If AIFA acknowledges that an authorisation procedure for the same medicines is pendent in another State Member, the application is not examined and it is made notice to the applicant that the process is regulated by the mutual recognition provisions.

Fee. According to Ministerial Decree 24th May 2004, the granting of a marketing authorisation requests a payment of a standard fee of € 55.680,00, due to the MoH for each single concentration relating to a dosage form of the product; in case of the abridged procedure the fee is cut by half.

The following additional fees might be charged, regardless if the normal or abridged procedure is undertaken:

- A € 5.568,00 fee for each further concentration or dosage form of the same product, provided that the application is submitted at the same time of the first marketing authorisation request ;

- A € 1.392,00 fee for every further packaging form supplementary to the same concentration and to the same dosage form, provided that the application is submitted at the same time of the first marketing authorisation request;

Abridged procedure The abridged procedure allows an application to be made without presentation of the results of pharmacological and toxicological tests or the results of clinical trials, but requires presentation of documentation showing the bioavailability in comparison with a cross-referenced product which has been marketed in Italy or in the EU for at least eight (8) years.

A medicines authorised with an abridge procedure cannot be marketed before ten (10) years from the first marketing authorisation of the cross-reference product.

Detailed reference to published scientific literature showing that the constituent(s) of the medicines have a well established medicinal use with a recognised efficacy and an acceptable level of safety.

If the cross reference product has not been authorised in Italy but in an EU State Member, the applicant must indicate the State the cross reference medicinal is authorised.

However, where the medicines is intended for a different therapeutic use or is to be administered in different doses, the results of the appropriate pharmaco-toxicological tests and clinical trials must be provided.

Period of authorisation and renewals. The National and mutual recognition authorisations shall be valid for five years from the date of publication of a Ministerial notice in the Official Gazette, and shall be renewable indefinitely, provided that AIFA, for justified reasons related to the pharmacovigilance, decides to renew it only for a five years period. The authorisation is renewed on application by the holder at least six months before the expiry date and after consideration by the competent authority of a dossier containing in particular details of the data on pharmacovigilance and other information relevant to the monitoring of the medicinal product. Any necessary amendment for the renewal are separately submitted to the competent office of AIFA.

The marketing authorisation expiries if the product is not actually marketed in the national territory within three years from the release and AIFA gives notice of it in the Official Gazette. If the product is not marketed on the national territory within 60 days from the initial validity date of the authorisation, the MA holder has to inform AIFA about the reasons of the delay and when the actual marketing will begin.

9.
Are the marketing authorisation requirements for over-the-counter (OTC) medicinal products the same as those outlined above? If not, please briefly outline how the requirements differ.
OTC products follow the same authorisation procedure as illustrated above.

10.
What powers does the regulator have to monitor compliance with marketing authorisations? Does it exercise those powers?
The powers granted to AIFA are quite broad and are actually put in practice. AIFA has a (i) power of checking and granting any modification of the MA; (ii) power of inspection to check that either the manufacturing either the marketing of the product is carried out in compliance with all applicable rules. Such powers are mainly performed by a special body of the police (“Nucleo Antisofisticazioni dei Carabinieri”).

· A special situation refers to the advertising of pharmaceutical products for which special rules apply (see below).

11.
In the event of a breach of the terms of a marketing authorisation, what are the regulator's powers of enforcement?
AIFA has the power to vary, suspend or revoke a marketing authorisation when:

· The information provided with the application is incorrect.
· The product proves to be harmful in the normal conditions of use.
· The therapeutic results cannot be obtained.
· The quali-quantitative composition is different from that declared.
· The controls over the finished product or its constituents or intermediate products have not been carried out, or the marketing authorisation holder omits to amend the analytical methods in order to ensure a safer control of the product based on the technical updating and scientific progress.

Before an authorisation is actually revoked, authorisation holder's has to be given the chance to submit his written or oral representations, within 15 days from the notice of the complaint. The revocation implies the definitive withdrawal of the product from the market within a specific term set by AIFA.

The revoking decision may be challenged by the authorisation holder and AIFA itself decides on the opposition after obtaining the Higher Health Committee opinion.

The law also provides for compulsory amendment to and/or suspension of marketing authorisations, sales bans (even in relation to specific batches), withdrawal from the market, and seizure.

12.
Is there a procedure for mutual recognition of foreign marketing authorisations? If so, please briefly outline the procedure.
If the holder of the authorization decides to submit to the competent authorities of other Member States an application based on the same dossier, the dossier has to contain all the information above, and the name of the State Members where the authorisation has been requested.

If Italy is indicated as the reference State, AIFA, on applicant’s request, within 90 days from the request, files an evaluation report on the product or updates the existing report. AIFA sends to the State members and to the applicant, its report, a summary of the characteristics of the product, the label and the leaflet approved.

If at the date of the submission of the application, the medicinal product is not authorised yet, AIFA on the applicant request, within 120 days from the request, draw up drafts of the evaluation report on the product, of the summary of the characteristics of the product, of the label and of the leaflet and send them to the State Members and to the applicant.

After 90 days from the receiving of the documents above from the State Members, if all the parts involved agree, AIFA close the procedure and inform the applicant of the result.

If one of the Member State does not approve either the evaluation report, the summary of the characteristic of the product, the label or the leaflet, the procedure provided by art. 29 of Directive 2001/83/EC applies.

13.
Are there any restrictions on marketing practices such as gifts or "incentive schemes" for healthcare establishments or individual medical practitioners?
Regulation of marketing and advertising practices is given by title VII of Decree 219/2006, stating that:

· Any gift or promotional aid (pecuniary or not) to practitioners or pharmacists is strictly forbidden, unless it can be shown to be inexpensive and relevant to the practice of medicine or pharmacy.
· Advertising material, not specifically related to the product, can be given only to the public hospitals, free of charge.
· Free samples of medicinal products, limited to a fixed quantity per practitioner, can be given only to practitioners who can prescribe them. A written request by the practitioner is required and the sample can be delivered only by reps.

Moreover, specific provisions refer to the duties and restrictions for pharmaceutical companies organizing or sponsoring meetings and conventions. In particular, all the events are subject to notification to and authorisation by AIFA. Expenses for congresses and meetings are fiscally deductible only for 40%.

The same restrictions as above are set also by the Ethic Code of Farmindustria, the association of the Pharmaceutical Companies.

14.
How are parallel imports regulated?
Parallel imports are regulated by Ministerial Decree of 28th September 1997. It provides that:

· an import-marketing authorisation from AIFA is required. Importer must show that the product fulfils given criteria and must provide the documentation, in Italian, proving, in particular, that the product has no difference in therapeutic effect from a product authorised in Italy or that the differences are as such that they do not affect quality, safeness and effectiveness. If satisfied with the application, AIFA issues the authorisation in 45 days. The payment of a fee is required.

· A sample of the imported product has to be made available to AIFA.
· If the product is re-packed, notice is to be given to AIFA.

15.
Is it possible to market medicinal products online, by e-mail and/or mail order?

According to Article 46 of Royal Decree No. 1706 of 30th September 1938 (never formally fully abrogated), pharmacies had a monopoly on the sale of medicinal products to the public. All sales must be made on the pharmacy’s premises.

This provision in very recent times has been partially abrogated by Law Decree 4 July 2006, n. 223 that provides that OTC medicines (over the counter) and SOP medicines (Senza Obbligo di Prescrizione – self-medication medicines), can be sold also by the large-scale retail, which comply with some specific rules.

In any case e-commerce is not possible, as well as sale of medicines products by email or mail orders.

Advertising
16.
Are there any restrictions on advertising medicinal products (both prescription-only and OTC)? If so, please briefly outline what these are.
Article 113 of Legislative decree no. 219/2006 provides the same definition of advertising of medicinal product as in the European Directive; in particular it includes any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.

Only OTC products can be advertised to the public. Advertising has to be authorised by the MoH, heard the opinion of a Committee of Experts (the opinion is always compulsory except when the advertising a)is manifestly prohibited; b) is to be published on the press or by radio and it has been approved by an Auto discipline Body c)is part of a already approved message).

The authorisation is deemed granted if no refusal is issued within 45 days of filing a request with the MoH.

Promotion of prescription products to the public is prohibited. Even the mention of the name of a prescription product in a context which is likely to encourage consumption is prohibited. They may be promoted only to general practitioners and to pharmacists in specific circumstances.

Other points to note include the following:

· Reps must have specific degrees. The average number of calls must be yearly notified to the Department.
· Pharmaceutical companies must have a person responsible for the “scientific service”, different from the person responsible for the pharmacovigilance.
· Thanks to Legislative decree no. 219/2006, for the first time in Italy the so called “Co-promotion” is expressly permitted provided that a specific agreement between the MA holder and the Pharmaceutical Company interested to co-promote the product is reached. Promotion may be performed only by a marketing or manufacturing authorisation holder.

E-promotion is subject to the same rules (that is, the promotional material for practitioners must be previously filed and the part of the website reserved for practitioners must be protected by a personal password and some kind of identification of the visitor as a doctor).

Anybody who infringes the law on advertising of medicines must immediately withdraw the advertisement and publish an apology and he is punishable with a administrative pecuniary sanction. Criminal sanctions no longer apply.

Packaging and labelling
17.
Please give a broad overview of the regulatory framework governing the packaging and labelling of medicinal products.
Labelling must contain all elements required by Article 54 of the Code for Human Medicines Directive. The labelling and leaflet must be in Italian. Packaging must bear the name of the product and special warnings, if needed, in Braille alphabet.

In addition to the name of the marketing authorisation holder, the outer package may also bear the name of the authorised distributor, provided authorisation is obtained from the MoH.

Reimbursable products must have a special bar code stamp affixed (“bollino autoadesivo”) identifying the product. This is bought from the governmental stationery office. When the product is dispensed, the stamp is detached by the pharmacist and affixed to a special medical prescription form for reimbursed products for control purposes.

Ministerial Decree 15 July 2004 implemented a system of labelling identifying and progressively numbering each single package.

Traditional herbal medicines
18.
Is the manufacture and marketing of traditional herbal medicinal products regulated in your jurisdiction? If so, please give an overview of the regime.
Directive 2004/24/EC on Traditional herbal medicinal products has been implemented by Legislative Decree no. 219/2006 as well. Under the decree, herbal remedies may be sold over the counter, under a simplified registration procedure, provided that they satisfy certain criteria and will be subject to the same safety requirements as for licensed herbal remedies. Herbal products registered under this procedure must be shown to have been in use for 30 years in the EU (or at least 15 years in the EU and 15 years elsewhere, or even less than 15 years if the product meets all the other requirements set by the law for the simplified registration).

Intellectual property
19.
What are the criteria for patentability?
Patent protection of pharmaceuticals in Italy dates from 1978, when a judgment of the Constitutional Court repealed the article of the Patent Law prohibiting patentability.

Recently, also biotechnologies can be patented according to Law no. 3 of 10 Genuary 2006 implementing EU Directive 98/44/EC.

The requirements for an invention to be patented are:

· Novelty (with respect to the state of art).
· An inventive step.
· Capability of industrial application.
· Lawfulness

Law no. 30/2005 makes applicable to the protection certificates (SPCs) the patent discipline, and allows the prolongation of the patent life to a maximum of 18 years.

20.
What is the procedure for obtaining patent protection, in particular:

· To whom should the application be made?
· What are the key stages of the process and timing?
· What fee is payable?
· For how long is protection given?
· What is the renewal process?
· In what circumstances can a patent be revoked?
· Is your jurisdiction a party to any international conventions on patent protection?

Application. A separate application must be filed for each invention. The application must contain:

· Full name, nationality and domicile of the inventor or the inventor's agent.
· Name of the invention and details of its main features and purposes.

The application must include as annexe a description of the invention (with a summary, claims and drawings).

Foreign applicants must have an Italian attorney or elect a domicile in Italy

Name: Ufficio Italiano Marchi e Brevetti (Italian Trademarks and Patents Office).
Contact details: V. Molise, 19 00187 Rome
Tel: +39 06 0647055654
Website: www.uibm.gov.it
Head: M. Ludovica Agrò

Process and timing. A patent is effective from the date the application is published. An application is published either:

· 18 months from the date the application is filed.

· 90 days from the date the application is filed, if the inventor expressly requests immediate publication.

Most of the patents covering pharmaceutical products are granted by the European Patent Office (EPO). Only few patents can be considered fully domestic.

Once the patent is published, it can be enforced against third parties.

The Italian Patent and Trademark Office (IPTO) (see box “Regulatory authorities”) currently takes around three years from the date of the filing the application to grant a patent. It examines the administrative and technical requirements, but not the novelty requirement.

There are no fees payable during the period between filing the application and grant of the patent, nor for publication and printing of the patent description and drawings.

· Fee. From 1st January 2006, all taxes related to the application and the yearly fees have been lifted. Therefore, the cost for the deposit of a patent depends on the technical difficulty of the invention and the necessary documents to file the description of the invention.

· Duration of protection. A patent is valid for 20 years from the date the application is filed.

· Renewal process. A patent is not renewable. In order to obtain a prorogation of the patent effects, see above on the SPCs.

· Revocation. A patent cannot be revoked but may be challenged before the courts if it is void or has to be considered as lapsed.

· International conventions. Italy has implemented the TRIPs agreement. Italy is also a party to Paris Union , PCT and the European Patent Convention of Munich.

21.
When is a patent infringed? What is the process for enforcing patent infringement and what remedies are available?
Pursuant to article 1.1 of Italian Patent Law, the patent rights consist of the exclusive right to put into practice the invention and draw profit from it in the territory of the state under the limits and conditions provided for in the Italian Patent Law. Article 1-bis.1(a) of Italian Patent Law specifies that, if the subject matter of the patent is a product, the owner has the exclusive right to prohibit any third party to manufacture, use, put into commerce, sell, or import for said purposes the product in question.

The Italian Patent Law also provides the “experimental use exception” (art. 1.3) according to which the exclusivity right do not include the acts performed privately and for not commercial purposes or on an experimental basis.

A patent holder can bring an action for infringement against those who infringe its exclusive rights. Italian Law no. 273 of 12th December 2002, as implemented by Legislative Decree 168/2003, has created "specialized sections" for IP-related matters in a limited number of courts (both first and second level). These sections "deal with cases of national and communitarian trademarks, patents for inventions and new plant varieties, utility models, pictures and models, author rights and all cases of unfair competition when these cases interfere with the protection of industrial and intellectual property". The action may include preliminary relief such as injunction, seizing and description (in order to form the evidence of the violation).

22.
Can product brands be protected by registration as a trade mark? If so, what is the test for obtaining trade mark protection?
The proprietary medicines, including OTC, must be branded and the trademark usually is registered (the Italian patent Law grants protection also in some special cases for non registered trademarkes).

To be registrable, a trade mark must be all of the following:

· Distinctive for the goods or services to which the application for registration relates.
· Not deceptive or contrary to law or morality.
· Not similar or identical to any earlier trade marks for the same or similar goods or services.

23.
What is the procedure for obtaining registration of a trade mark, in particular:

· To whom should the application be made?
· What are the key stages of the process and timing?
· What fee is payable?
· For how long is protection given?
· What is the renewal process?
· In what circumstances can a trade mark be revoked?
· Is your jurisdiction a party to any international conventions on trade mark protection?

A large number of trademarkes are actually granted trough OHIM procedure.

Application. An application for trademark registration should be filed with a Chamber of commerce or directly at the IPTO.

Contact details.
Name: Ufficio Italiano Marchi e Brevetti (Italian Trademarks and Patents Office).
Contact details: V. Molise, 19 00187 Rome
Tel: +39 06 0647055654
Website: www.uibm.gov.it
Head: M. Ludovica Agrò

Process and timing. A standard application form is used, and it may be download also from internet at the address http://www.uibm.gov.it/public/moduloC.pdf. The application can only be lodged by an entity with ownership rights under trademark law and international agreements and must be for a single mark. The application must contain a sample of the mark and should indicate the type of product or service it will distinguish according to the international classification of products and services. IPTO will examine the application ensuring that it is in accordance with the absolute requirements of registration, but will not examine the novelty requirement. Italian legislation provides for an opposition procedure before registration, in accordance with the Madrid Protocol related to the Madrid Arrangement signed on 27th June 1989 (Legislative Decree n. 447/1999).

Fee. Details of the fees are set out on the Italian Office for patent and trademark (UIBM) website (see http://www.uibm.gov.it/public/tasse.pdf)

Duration of protection. Trademark protection lasts for ten years from the date of the application.

Renewal process. A trademark is renewable for a further ten years period using the same procedure as for the filing of the first application.

Revocation. A trademark registration cannot not be revoked, but may be challenged before the courts if the registration is void or lapsed, that is because:

- non-use for a continuous period of five years;
- the mark has become a common term in the trade;
- the use of the mark has led to the possibility of the public being misled;

A patent or trademark holder with exclusive rights can bring an action for infringement against those who infringe its exclusive rights. The action is under the jurisdiction of the ordinary courts and may include preliminary relief such as injunction and description (in order to form the evidence of the violation)

International conventions. Italy is party to the:

· Paris Convention;
· WIPO Protocol.
· Madrid Protocol.

When is a registered trade mark infringed? What is the process for enforcing brand or trade mark infringement and what remedies are available?

Typical cases of trade mark infringements are:

- identity of marks and products;
- similarity of trade marks as such that it generates a risk of confusion;

The action is under the jurisdiction of “specialized sections” (see above point 21) and may include preliminary relief such as judicial attachment, injunction and description (in order to form the evidence of the violation). In certain circumstances, counterfeiting amounts to a criminal offence and artt. 473, 474 e 517of the Criminal Code are applicable.

Product liability
24.
Please give an overview of product liability law, in particular:
· Under what laws can liability arise (for example, contract, tort or statute)?
· Who is potentially liable for a defective product?
· What is the substantive test for liability?
· What is/are the limitation period(s) for product liability claims?
· What defences are available?
· What remedies are available to the claimant?
Legal provisions. Legislative Decree n. 206/2005 introducing a Consumer Code, contains specific provisions on the producer liability for defective products. The definition of “producer” provides that manufacturers (active ingredient and finished product), the marketing authorisation holder and the distributor with its name appearing on the outer package are all potentially liable.

On the other hand, there are no specific rules concerning liability for defective medicinal products. When law 206/2005 does not apply, the producer liability follows the tort law rules ex articles 2043-2050 of the Italian Civil Code.

Wilful or negligent commercialisation of imperfect medicinal products may also result in criminal liability.

Who is liable?

· Consumer Code: Producer is liable for damages arising from defective products whilst, when the producer cannot be identified, liability falls on the supplier if he is not able to identify the manufacturer. In case of products imported from non EU-States, the distributor is liable together with the producer if the importer is unknown.

· Tort Law: the manufacturer is liable for damages caused to the product’s user.

Substantive test.

· Consumer Code: The plaintiff must prove the defect, the damage and the causal link between the two. Producer must give evidence that one of the liability exclusion cases occurred (see below); actually, it is sufficient to prove that the product was not likely to be defective when it was put on commerce. Compensation for damages is possible only when the damage, once quantified, is higher than € 387,00.

· Tort Law: The tort law provides that if the defendant performs dangerous activities (including the pharmaceutical industry), the plaintiff must prove the damage and a causal link, and it is then up to the defendant to prove that he adopted all the measures capable to prevent damage.

Limitation period.

· Consumer Code: Liability is limited for a three year period, starting from the day the user did or should have acknowledged the damage, the defect and the identity of the producer. The rights conferred on the injured person are extinguished after ten years from the date on which the producer put into circulation the actual product which caused the damage

· Tort Law: Liability is limited for a five year period starting from the day the fact occurred.

Defences.

Consumer Code: The producer is not liable if it proves that:

· it did not put the product into circulation;

· the defect which caused the damage did not exist at the time the product was put into circulation;

· the product was not manufactured for an economic purpose or in the course of its business;

· the defect is due to compliance with mandatory regulations;

· the state of scientific and technical knowledge at the time was not such as to enable the existence of the defect to be discovered;

· in the case of a component manufacturer, the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the manufacturer of that product.

Tort Law: the defendant must prove that he did everything he could (using the most advanced and innovative technological measures) in order to prevent the damage.

Remedies. Where a personal injury has been sustained, the claimant can recover damages by way of monetary compensation which is calculated on the basis of:

- loss of future earnings;
- actual damage.
- Moral damage;
- Existential damage;
- Biological damage.

25.
Are class actions permitted for product liability claims? If so, how common are they?
Up until now (see question n. 26 below) class actions are not allowed in Italy. Nevertheless, civil actions lodged by more than one claimant, provided that they are all named, are possible. Moreover, recently also Category Association are allowed to take actions before the Courts to safeguard the interests of their associates.

Future developments
26.
Please summarise any impending developments in the regulation of medicinal products, patent and trade mark law, and product liability.
The Government has brought a bill before Parliament to introduce in Italy class action. The legislative procedure for its approval has just begun and at the moment is not predictable when (and if) will end.

The regulatory authorities
Name: Ministero della sanità (Ministry of Health)
Contact details:
Lungotevere Ripa, 1
00153 Rome
Viale dell’Industria, 20
00144 Roma

Tel. +39 06 59 941
Fax. +39 06 59 64 77 49
Website: www.ministerosalute.it
Head: Mrs Livia Turco
Areas of responsibility. General policy and political decisions on healthcare matters.

Name. Istituto Superiore di Sanità (Higher Health Council)
Contact details:
Viale Regina Elena, 299
00161 Rome
Tel: +39 06 49901
Fax: +39 06 4938118
Website: www.iss.it
Head: Enrico Geraci

Areas of responsibility. The technical-scientific body of the NHS and within its many duties is the control of new drugs before the authorisation of clinical trials.

Name. Consiglio Superiore di Sanità (Higher Health Council).
Address, Tel and Fax: c/o Ministry of Health
Head: Mario Condorelli
Website: www.ministerosalute.it/ministero/sezMinistero.jsp?id=4&label=ssn
Areas of responsibility. Give opinions (non-binding) in cases of revocation of marketing authorisations.

Name. Agenzia Italiana del Farmaco (AIFA)
Contact details. Via della Sierra Nevada, 60
00144 Rome
Tel: +39 06 5978401

Website: www.agenziafarmaco.it

Areas of responsibility. AIFA is composed by 4 Technical Committees with different specific competence: i) Technical Scientific ii) Price and reimbursement iii) network Region-Provinces iv) Promotion of Research and Development. In order to see AIFA responsibilities, see above question no. 1.

Law 22nd February, 1994, no 146 has instituted a special Commission for Homeopathic Products (contact details are the same as for the Department of evaluation of medicinal products).

Name: Ufficio Italiano Marchi e Brevetti (Italian Trademarks and Patents Office)
Contact details: V. Molise, 19 00187 Rome
Tel: +39 0647055654
Fax: +39 06 47053035
Website: www.uibm.gov.it
Head: M. Ludovica Agrò

Areas of responsibility. The administration of patents and trade marks.

Elenco articoli