Tag Archives: italy

Health Data Registries and Surveillance Programs, a New Italian Regulation Steps Up the Game

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A new Italian regulation governing health data registries and surveillance programs aims at facilitating the use of such tools for purposes of monitoring health of the population, as well as healthcare spending. A comprehensive legal instrument regulating the various categories of registries and programs was much needed. In fact, the adoption of such a regulation was envisaged by national legislation since 2012 (Section 10 of law decree 179/2012), but no implementing measures has yet been adopted. A draft of regulation has now been released by the Italian government and submitted to the State-Regions conference prior to formal entry into force. The draft has already been reviewed by the Italian Data Protection Authority.

The new regulation aims at standardizing registries and programs adopted over the years, by setting forth: (i) the entities and professionals who may access the information contained in the registries, (ii) the categories of data that are available, and (iii) the measures to be adopted to ensure the security of data in line with data protection legislation.

The goals pursued by the regulation include a better monitoring of diseases at national level and relating treatment, survival rates, mortality index, as well as the increase or decrease over time of a certain disease. The data stored in the registries should also facilitate the carrying out of epidemiological studies in specific territories and/or for specific subsets of the population. Such broad purposes would allow the data to be used in connection with scientific studies, but also for the treatment and prevention of particular diseases.

The data protection provisions enshrined in the regulation are particularly stringent, and provide that all data must be processed by individuals specifically appointed by the data controller and subject to secrecy obligations. Furthermore, the data shall be encoded in a way that does not allow the de-anonymization of the data. Only in case of adverse events and relating field actions, data may be used to contact the interested subject upon prior authorization of the national registry holder. Data breaches will also need to be reported to the Data Protection Authority.

In conclusion, the new regulation provides welcome clarity in a field where regulations have been sporadic and at times incoherent. Moreover, the new regulation seeks to govern at the same time the different legal aspects connected with registries, from healthcare monitoring to data protection. There is little doubt that the hope of the government is to optimize such instruments to better control healthcare spending and conduct a more effective assessment of therapies and products on the market.

 

 

Another September, Another Spending Review.

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This is almost becoming a tradition for the national healthcare service in Italy. Comes September… and a new spending review hits the pharmaceutical and medical device industry.

On August 4, 2015 a law decree has been approved by lawmakers, which introduces a number of new mechanisms for monitoring and reining in public spending in the healthcare sector. In particular, the new legislation has introduced several measures:

  • Negotiations with current suppliers of the national healthcare service in order to achieve a 5% reduction in current spending for general supplies;
  • Negotiations with current suppliers of medical devices in order to comply with the spending thresholds agreed upon between the central government and regional authorities;
  • Centralized negotiations with pharmaceutical companies in order to decrease the reimbursement price of products currently reimbursed by the national healthcare service.

While measures aimed at cutting spending in connection with general supplies and medical devices have been entrusted in principle to local authorities and healthcare providers, the national pharmaceutical agency (“AIFA”) plays a central role in the envisaged mechanism to achieve savings for pharmaceutical products. In accordance with the provisions of the new decree, AIFA has indeed conducted negotiations throughout the month of September 2015, with the aim of decreasing overall spending. The new legislation provides the grouping of products in several “clusters” that include therapeutically similar products, regardless of their active principles. The lowest price in each cluster is then used as the reference price for direct negotiations between AIFA and manufacturers.

The new measures also provide that, in case of failure to reach an agreement, reimbursement by the national healthcare service may be withdrawn. However, it is also expressly provided that generic products are not admitted to reimbursement until any patents and supplementary protection certificates of branded products are definitely expired, thus providing the industry with assurances in connection with their protected drugs.

The reiterated attempts by public authorities to renegotiate prices with suppliers appear to clash not only with basic contractual principles (“pacta sunt servanda”), but also with fundamental rules of public procurement legislation. As the government (in fact, almost yearly) demands discounts on existing contracts, reliance on such contracts is affected, along with transparency and open competition in public procurement procedures. The truth is that the need to cut public expenditures is increasingly overriding basic tenets of contracts and public procurement law.

Med Tech and Pharma industry associations have voiced their concerns, while suggesting that efficiency and savings may be obtained by the national healthcare service through internal reorganization processes rather than by demanding additional discounts to suppliers. In fact, if we step aside from the conflicting commercial interests of suppliers (who want to maximize their revenues) and purchasers (who need to minimize their costs), we cannot but note that, again, the government appears to use cost cutting tools that focus on quantity rather than quality. On the contrary, we would expect that more emphasis should be given to Health Technology Assessment and innovation. We surely need to spend less money, but also to spend it more wisely.

Electronic Medical Record: Italian Data Protection Authority Issues New Guidelines

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On June 4, 2015, the Italian Data Protection Authority issued new guidelines governing the collection and processing of personal and sensitive data through the Electronic Medical Record.

  • What is an Electronic Medical Record?

A record, kept by a hospital or a healthcare center, containing patients’ clinical history at that specific hospital or healthcare center.

  • Patients’ rights

The guidelines set forth several rights to which patients treated at any hospital or healthcare center are entitled:

  1. Patients are entitled to decide whether the hospital or the healthcare center may store their data through an Electronic Medical Record. If a patient denies his/her consent, physicians will be able to rely only on information gathered during examination and treatment, as well as on information previously conveyed by the patient, if any. Denial of consent will not affect the possibility of being treated at the hospital/healthcare center.
  2. Specific consent is needed for the collection of certain categories of sensitive date, such as HIV infections, abortions, data relating to sexual assault. With respect to such data, patients will have the right to limit access to specific individuals/professionals.
  3. In addition to all rights granted by the Data Protection Code (such as the right to receive confirmation on the existence of personal/sensitive data, to know the origin of the data, the purpose and means of processing, as well as the logic applied to the processing) patients will also be entitled to receive information on each access to their Electronic Medical Record.
  • Hospitals and healthcare centers’ obligations

Hospitals and healthcare centers are required to provide patients with a thorough privacy notice concerning the processing of data through the Electronic Medical Record. Upon patients’ request, hospitals and healthcare centers shall also provide information concerning stored data and access logs to the Electronic Medical Record (including the professional accessing the data, date and time of access) within 15 days of the request. Patients will also be entitled to redact data or healthcare documentation that they do not wish to be included in their Electronic Medical Record.

The Data Protection Authority’s guidelines also address important technical aspects and provide that patients’ healthcare information contained in the Electronic Medical Record shall be segregated from other administrative data. Sensitive data will need to be encrypted. Furthermore, access to the record will be granted only to medical staff involved in the patient’s treatment and any access and processing will be recorded on log files to be kept by the hospital or healthcare center for at least 24 months.

Lastly, the guidelines set forth strict data breach requirements for hospitals and healthcare center, by providing that any data breach or unauthorized access shall be reported to the Data Protection Authority within 48 hours of knowledge of the breach. Failure to report will lead to the application of penalties.

See the Data Protection Authority’s presentation of the new guidelines

What’s New in E-Health? Interesting Developments to Consider.

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E-Health is a term often used to describe a relationship established between electronic tools and the art of medicine. The European e-Health Action Plan 2012-2020, for example, describes e-Health as a “mean using digital tools and services for health”, which involves an interaction between patients and health-services providers. Within e-Health, the role of telemedicine is considerably growing.

Regulations and guidelines in the field of e-Health are growing in the Italian jurisdiction, too. In particular:

  1. A new Agreement on Digital Health (“Patto per la Sanità Digitale”) prepared by the Ministry of Health has been proposed to the State and Region Conference in June 2015
  2. New guidelines on electronic health records have been issued by the Data Protection Authority on June 4, 2015; and
  3. An interesting administrative court decision issued on July 10, 2015 set forth innovative principles in the field of digital health supplies to the public administration.

Our next blog posts will explore the above developments, which are set to change certain regulatory aspects of e-Health.

Stay tuned, and happy summer!

Courts Limit Administration’s Discretion in Public Contracts

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Recent rulings by two administrative courts in Italy have restricted the discretion of public entities in the award of public contracts without open procurement procedures, in particular in the healthcare sector. The two decisions reaffirm the Courts’ policy of restricting recourse to in-house contracts and extensions of expired contracts.

The first decision, issued on May 7, 2015 by the Supreme Administrative Court in Rome, invalidated the award of a service contract to a company established and owned by the regional government of Puglia for the provision of in-house services to healthcare facilities in the region. The contract was awarded without a public procurement procedure, on the basis of the fact that it was an in-house service contract. The Court, deciding upon an appeal brought by a competitor who was not granted the possibility to submit its offer, held that a procurement procedure open to competitors must always occur, even if a governmental entity has established a specific vehicle for the purpose of providing in-house services. The Court left a limited room for in-house services, i.e., services provided by an entity fully controlled and managed by the same administration awarding the contract, as if it was one of its internal departments.

On a different occasion, the regional administrative Court of Turin had the chance to reiterate that the extension of expired public contracts is prohibited by public procurement legislation, as it prevents competitors from participating in new public procurement procedures. In addition to stating again this general principle, the Court in its decision of April 3, 2015 no. 573 also held that governmental entities should proceed with calls for tenders whenever the goods or services they intend to procure are not covered by a national or regional framework agreement. In an effort to curb public spending, the Italian government has implemented in several sectors a centralized negotiation process, whereby a central governmental agency (“Consip”) enters into framework agreements for the supply of goods and services to local administrations. Local administrations are generally bound to adhere to such framework agreements and, if they do so, no call for tender needs to be issued. Public hospitals, on the other hand, must adhere to healthcare-specific regional framework agreements and to Consip agreements; only if no such agreements exist they may proceed with the issuance of a call for tenders.

In the case the before the Court, a local healthcare office postponed the validity of an expired supply contract, after assessing that the framework agreement entered into by Consip would have only partially covered the needs of the local administration and – most importantly – would have entailed a higher cost than the expired agreement. Regardless of the potential savings that the extension of the existing contract would have granted the public administration, the Court held that no exceptions can be envisaged to the issuance of a public procurement procedure. Clearly, more than by savings, the Court must have been guided by the desire to sanction a widespread practice of extending expired contracts, which in most cases stifles competition and does not guarantee lower prices.

It is expected that this policy, increasingly adopted by many administrative Courts, will be one of the highlights of the new public procurement legislation that is currently being examined by Italian lawmakers. The new public procurement code is, in fact, expected to provide new instruments for a more effective fight against corruption and inefficiencies within the public administration.

Legality Rating by the Italian Antitrust Authority: Is It Useful?

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“Not only must we punish corrupt companies but also encourage healthy businesses“. The statement released by Mr. Raffaele Cantone, Chairman of the Italian Anti Corruption Authority, summarizes the rationale underpinning the so called “legality rating”, i.e. a score that the Italian Antitrust Authority assigns to companies who apply for it. In fact, Law no. 62/2012, converting Law Decree no. 29/2012, requires the Italian Antitrust Authority to assign a score ranging from one to three “stars”, to any applying company who complies with a series of legal requirements (inter alia, the absence of criminal sanctions or preventive/precautionary measures against key personnel of the company, no judgments pursuant to Legislative Decree No. 231/2001, no breaches in the field of health and safety at work, and no definitive tax assessments against the company).

The instrument, available to entities generating a turnover in excess of Euro two million per year, is completely optional, but continues to be widely utilized. A statement of the Antitrust Authority shows in fact that, in January 2015, the Authority  received respectively 14% more applications than in the previous month and the trend seems to continue.

So, companies line up as schoolboys in order to show that they are worth a certain number of “stars” in an effort to demonstrate the soundness of their compliance program: is it worth it? To respond, we have looked into the benefits of the legality rating to understand the actual relevance of a practice that is becoming widespread. Below is a summary of the alleged benefits.

  • A new Regulation, developed by the Italian Antitrust Authority in collaboration with the National Anti Corruption Authority, entered into force on November 14, 2012, sets forth that companies benefitting from a legality rating are enrolled in a register of virtuous firms. Such registration is supposed tofacilitate relations with banks or the granting of public funding as well as the possibility to participate in public tenders.
  • The first example of a public procurement process taking into account the legality rating refers to postal services. The procurement documentation (Decision of December 9, 2014, published in the Official Gazette no. 1 of the January 2, 2015) stated for the first time that “for the public procurement of large size, the contracting authorities can evaluate the opportunity to give an additional and proportionate score to companies that benefit from a legality rating issued by the Antitrust Authority pursuant to §. 5 ter of Law-Decree no. 1 of January 24, 2012, or that have equivalent certifications issued to foreign firms from other agencies or public authorities”. For the first time, legality rating actually mattered as it gave a chance to companies to score additional points in public tenders.Some have criticized the use of a legality rating in this context, given that section 83 of the Italian Public Procurement Code (Legislative Decree no. 163/2006) requires that contracting authorities assess bidding companies on the basis of objective requirements only. It has been in fact argued that making reference to a legality rating is too discretionary. However, the Antitrust Authority, in opinion no. 163/2013, seemingly admits the possibility of using discretionary requirements, such as “the curriculum of the company, possession of licenses or quality certifications, availability of business assets, the providing of services or similar work, and in general, skills and references” as “factors that can be weighedas criteria for admission to tenders”.

In conclusion, if public procurement tenders give some weight to the legality rating, then obtaining it may actually be a good idea.

The risk is, as with any type of certification, that it will become a merely formal requirement, which does not attest the actual compliance efforts or a corporation’s culture.

Hospital Use Of ATMPs: Toward A Stronger Protection Of Patients Resorting To Compassionate Use

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The Italian Ministry of Health has recently strengthened the requirements to obtain the authorization to manufacture and use advanced therapy medicinal products (“ATMPs” [1]) which are non-routinely produced. In fact, following the enactment of the Decree of the Ministry of Health of January 16th, 2015, published only last week (the “ATMP Decree”)[2], more control on such drugs’ hospital use is expected. The ATMP Decree does not apply to ATMPs under clinical trial and solely focus on compassionate use of non-routine ATMPs.

THE PREVIOUS REGULATORY SCENARIO. Prior to 2006, the use of gene therapy and cell therapy medicinal products, for which a marketing authorization had not been obtained, was authorized only within clinical trials[3]. In 2006[4] non-profit manufacturing and compassionate use[5] of gene therapy and somatic cell therapy medicinal products was first allowed.

The 2006 Decree allowed the use of such products on the basis of certain requirements, checked by the Agenzia Italiana del Farmaco, the governmental agency in charge of pharmaceuticals (“AIFA”). Given the lack of therapeutic alternatives in a life threatening condition, the requirements for production and use of gene therapy and cell therapy medicinal products were not especially strict and heavily relied on the patient’s consent and positive feedback by the Ethics Committee, as well as on the self-certification on the existence of the requirements by the doctor responsible for the drugs administering.

THE NEW RULES INTRODUCED. The ATMP Decree was introduced to protect consumers from fraudulent conducts. Even though the Decree does not make specific reference to it, it is widely accepted that the ATMP Decree aims at limiting the proliferation of cases like the famous “Stamina case”, where therapies for treatment of life-threatening diseases have been provided to patients in sheer lack of scientific grounds[6]. AIFA will enforce the new rules by way of on-site inspections that may lead to suspension or revocation of a previously granted authorization to manufacture, as well as to the prohibition to administer the drug. The ATMP Decree can be summarized as follows:

  • AUTHORIZATION TO MANUFACTURE. Manufacturing of ATMPs for non-routine hospital use now requires a prior authorization by AIFA, which is only issued to GMP (Good Manufacturing Practices) certified manufacturers[7]. Prior to issuing its authorization, AIFA checks compliance of the manufacturing site. The process may altogether take up to 120 days, save for further inquiries by AIFA[8].
  • AUTHORIZATION TO USE. Use of ATMPs is limited to “compassionate use”. Only certain public research hospitals will be suitable candidates to obtain AIFA’s authorization[9]. Moreover, the authorization will be released only upon approval by (i) a Committee for the Assessment of Admissibility to Phase I of Clinical Trials, composed of expert biologists and clinicians, and (ii) by the concerned hospital’s Ethical Committee. The authorization is issued after an analysis of all documents necessary to assess risks and benefits of the proposed treatment, as well as data concerning safety and efficacy available from previous clinical trials.
  • COOPERATION BY MANUFACTURERS AND PHYSICIANS.
    • Manufacturers of ATMPs must ensure traceability of medicinal products as well as of patients for thirty years, and must report to AIFA any adverse events. Also, manufacturers can deliver ATMPs only after authorization to use has been issued and in compliance with a physicians’ prescriptions.
    • Physicians, on the other hand, must ensure that the patient’s informed consent is obtained, and must comply with Good Clinical Practice principles in administering ATMPs in accordance with the protocol approved by the Ethics Committee. Finally, traceability of the drug and patient must be ensured and adverse events must be communicated promptly.

CONCLUSIONS. Manufacturing and use of ATMPs on non-routine basis shall follow objective requirements, to be assessed by governmental entities who are able to appreciate their scientific basis, rather than – as in the past – used under the mere responsibility of physicians and on the basis of self-certified manufacturing facilities. If, on the one hand, it would be advisable that all who need to resort to compassionate use of medicinal products can access medicinal products as quickly as possible, on the other hand it must be ensured that the same people receive adequate protection from deceitful conducts. The Stamina case showed how vulnerable to deception patients who are in a life threatening condition without any available cure can be to false hopes spread by therapies without scientific basis: the recent ATMP Decree attempts to protect them.

 

[1] According to Section 2 of Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004 ATMPs include gene therapy products, somatic cell therapy products and tissue engineered products.

[2] The ATMP Decree has been published on the Official Gazette no. 56 of March 9th, 2015 and will become effective fifteen days after publication.

[3] See Section 1 of Ministerial Decree of March 2, 2004. Such non-routinely manufactured drugs were also excluded by the scope of the Pharma Code (Legislative Decree no. 219 of 2006) which focused on the industrial manufacturing of medicinal products and excluded non-routine drugs from its scope.

[4] Ministerial Decree n. 25520 of December 5th, 2006.

[5] According to Ministerial Decree n. 11521 of May 8th, 2013 “compassionate use” or “expanded access” of medicinal products may occur when no suitable alternative is available, in case of life-threatening situations, when serious harm to a patient’s health is potential, or in case of serious diseases with fast progression.

[6] The “Stamina Method”, created by Prof. Vannoni for the treatment of neurodegenerative diseases, is based on the conversion of mesenchymal stem cells into neurons and apparently lacks any scientific foundation. The method itself was also harshly criticized by Nature, one of the most prestigious scientific journals (http://www.nature.com/news/italian-stem-cell-trial-based-on-flawed-data-1.13329). Prof. Vannoni manufactured ATMPs while completely disregarding GMPs. Prof. Vannoni was criminally charged and prosecuted for organized crime with the purpose of fraud and recently plea bargained.

[7] Principles and guidelines of GMPs are contained in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.

[8] The process also includes submittal of request for authorization, along with a report on the ATMP.

New Transparency List For Generics And A Victory In Court

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On February 16, 2015 the Italian Medicines Agency (“AIFA”) has published the 2015 update to the so called “transparency list” (lista di trasparenza), i.e., a list of generic drugs authorized in Italy, along with their market price.

Following a number of changes in the legislation governing generics in the past few years, the National Health Service currently only reimburses the cost of the less expensive generic on the market. In fact, Section 7 of Law Decree 347/2001 sets forth the medicines having the same active ingredients composition, pharmaceutical form, way of administration, release modalities, number of tablets and dosage, are reimbursed by the National Health Service up to the price of the less expensive product on the market. The transparency list serves as a tool for reimbursement purposes: if the patient chooses to buy a branded product or a more expensive generic, the patient will need to cover the difference in price.

The publication of the transparency list comes shortly after a recent decision of the highest Italian administrative court, which stroke down past practices of AIFA on the reimbursement of new generics. In this case, the generic drug company EG S.p.A. claimed that AIFA issued a marketing authorization for gabapentin (a generic drug approved in a different EU member state) but unduly refused to recognize any reimbursement. The per-tablet dosage of the generic drug was in fact different from the branded product and other generics already included in the transparency list: therefore, according to AIFA, reimbursement was not warranted by Section 7 of Law Decree 347/2001. AIFA also argued that the new dosage, higher than other reimbursed products, entailed risks for the patients’ safety, as they would have to apportion the right dosage themselves (e.g., to split the drug tablets in half). The administrative court stated that such risk was ungrounded and had no impact on the reimbursement of the drug: if at all, it should have prevented AIFA from issuing a marketing authorization in the first place. Furthermore, the court stated that the National Health Service may reimburse a generic even if not included in the transparency list, striking down AIFA’s argument that dosages already reimbursed by the National Health Service sufficiently covered the needs of the patients, as such criterion was not set forth in applicable legislation.

The court decision comes as the latest victory for generics on the Italian market, adding to several regulatory and legislative changes prompted by budged restraints in the past few years, causing generics to continue gaining strength. In the meantime, proposed new legislation on the sale of generics outside of authorized pharmacies is stirring public debate.

Tax Relief on Exploitation of Intellectual Property Rights and Know-How

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INTRODUCTION OF THE SO CALLED “IP BOX”. Law no. 190 of December 23, 2014 (“Law”), provides for a new regulatory framework concerning taxation of revenue arising from exploitation of intellectual property rights and know-how eligible for legal protection.

Starting from 2015, repatriation of intangible assets owned by Italian and foreign companies abroad will be favored. Exportation or re-exportation of intangible assets to countries having more favorable taxation of revenue arising from exploitation of intellectual property rights will likely decrease, whereas investments in R&D activities in Italy should increase.

SCOPE OF THE LAW. The Law expressly covers works of intellect, patents, trademarks, design, models, processes, formulas, as well as industrial, commercial, and scientific know-how eligible for legal protection[1]. Revenue arising from both direct and indirect exploitation will receive a more favorable taxation as profits from licensing of eligible assets as well as their direct use (e.g. use of patented machineries in manufacturing processes) will be partially excluded from companies’ taxable income. The Law provides for a progressive implementation of the tax relief system. In 2015, only 30% of the profits will be excluded, whereas such percentage will increase to 40% in 2016, and to 50% in 2017[2].

Capital gains arising from sale of eligible intangible assets will be entirely tax-exempt, upon condition that at least 90% of sales revenue are invested, within two years from the relevant sale, in maintenance or development of any of such assets.

It must be noted that the tax relief will not automatically apply to all eligible entities. Instead, companies must expressly opt for the regime, and their choice will be binding and irrevocable for the following five fiscal years.

WHO CAN BENEFIT. Entities carrying out business activity in Italy, regardless of their type or size, can benefit from the new taxation regime. Foreign companies and other incorporated or non-incorporated entities, including trusts, carrying out business activity in Italy through a permanent establishment, can also benefit from the newly introduced regulatory framework provided that their country of residency is a party to a double tax treaty and undertakes to exchange relevant information with Italy.

CONDITIONS. The exclusion of profits from corporate income will apply only to those entities that carry out R&D activities by way of contracts entered into with either universities or equivalent research entities, or with companies other than those belonging to the same group[3].

In case of direct exploitation of eligible intangible assets, companies must conclude an advanced pricing agreement (APA) with the Agenzia delle Entrate (the Italian tax agency) to determine the ratio between the production value of the assets and the corporate income[4]. Such an agreement is optional for revenue arising from exploitation of eligible assets within the same group[5], whereas it is mandatory in case of capital gains deriving from sale of the assets.

EXEMPTED INCOME. Not all of corporate income benefits from the tax relief. The benefitting quota is instead calculated on the basis of the ratio between R&D costs incurred for maintenance and development[6] of eligible intangible assets and overall costs borne to produce such assets.

[1] The Law originally provided for works of intellect, patents, trademarks that are functionally equivalent to patents, processes, formulas and know-how eligible for legal protection. The meaning of “trademarks functionally equivalent to patents” has been debated ever since, with experts stating that such trademarks could be indentified in those trademarks used to market patented inventions. The recent Law Decree no. 3 of January 24th, 2015 (currently still to be converted into law) expanded the scope of the Law to all kind of trademarks, therefore also to purely commercial trademarks, as well as to design and models.

It must be noted that the scope of the Law is wider than what provided in other European countries by similar tax regimes, where tax relief is usually limited to exploitation of patents. Such systems are therefore commonly defined as “Patent Box”.

[2] The exemption is relevant to calculation of both IRES (corporate income tax) and IRAP (regional tax on production). It is estimated that, starting from 2017, revenue arising from exploitation of eligible assets will be taxed at a rate of 13.75%.

[3] The provision is aligned with the “nexus approach” adopted by OECD, aiming at limiting harmful tax competition amongst OECD countries. According to such an approach, tax relief is to be granted only when R&D costs are incurred, therefore hindering companies from exporting intangible assets to countries with more favorable tax rates without carrying out any R&D activity in such countries. (For further information on this issue visit http://www.oecd.org/ctp/beps-2014-deliverables.htm)

[4] The agreement is reached upon an international ruling procedure that is usually applied with regards to transfer pricing and dividends within the context of multinational companies.

[5] The Law originally provided for a mandatory agreement also in case of exploitation within the same group. Law Decree no. 3 of January 24, 2015, made such an agreement optional. Please note that the agreement may remain mandatory if the law decree is not converted into law or if it is modified by the law of conversion.

[6] Law Decree no. 3 of January 24, 2015, provides that such costs are increased by those incurred for the purchase of the asset or for research contracts entered into with companies belonging to the same group up to 30% of maintenance and development costs.