Tag Archives: healthcare

Repeal of Patent Linkage in Italy is on the Horizon

The patent linkage is the practice of linking the marketing authorisation of medicinal products, their pricing or reimbursement, or any other generic drug approval, to the patent status of the original reference product.

On 4 November 2021 the Italian Council of Ministers approved the draft law for the market and competition for the year 2021 (the “Draft Law”), by means of which by the end of this year the Italian Government intends to modify, update and renovate the regulatory framework of several critical sectors of the economic life of the country, amongst which energy, transportation, entrepreneurship and healthcare.

With the aim of removing barriers to market entry for generic medicines, the Draft Law inter alia provides for the abolition of the patent linkage, finally bringing Italy, on this point, in line with the EU law and the other European countries.

Indeed, the Draft Law repeals article 11, paragraph 1, of Law no. 189/2012 (the “Balduzzi Decree”), pursuant to which generic drugs cannot be included in the list of the medicines reimbursed by the Italian National Health Service before the expiry date of the patent or of the supplementary protection certificate of the corresponding originator’s product.

Because it establishes a patent linkage, said provision of the Balduzzi Decree is generally held in breach of the EU law, according to which regulatory bodies, when granting a marketing authorisation for a medicine, setting its price, and determining its class of reimbursement, cannot consider the patent coverage, but only the quality, safety, and efficacy of medicines.

In the last decade the Italian association of generic drug manufacturers (Assogenerici), several patient advocacy groups and even the Italian Competition Authority had tried to push the Italian Government to repeal article 11, paragraph 1, of the Balduzzi Decree, but without success. Now, probably also under the EU Commission’s pressures to comply with the requirements it set in the framework of the aids given to Italy to face the economic and social consequences of the Covid-19 pandemic, the Italian Government decided to finally remove the patent linkage.

The purpose of the measure provided by the Draft Law is to allow manufacturers of generic medicines to carry out all the negotiation procedures for price and reimbursement to be ready to enter the market as soon as the patent expires, and so to increase the competition in the healthcare sector.

The Draft Law will be soon submitted to the Italian Parliament, where it will be discussed and where it might be subject to several and significant amendments. We will see whether the abolition of the patent linkage will be eventually approved and will therefore become law.

Italian Data Protection Authority Plans to Inspect Life Sciences Companies in 2020

The Italian Data Protection Authority has recently issued its inspection plan for the first half of 2020. The Authority plans about 80 inspections through the fiscal police. 

Inter alia, the Authority plans to inspect health data processing carried out by multinational companies operating in the pharma and health sector. In case that’s what you do, make sure your GDPR documents are in order.

Other industries will also be impacted, such as whistleblowing software, marketing, online banking, food delivery and call center services.

In 2019 the Italian Data Protection Authority has issued sanctions amounting to Euro 15,910,390.

Clarifications on the Processing of Health Data by the Italian Data Protection Authority

The Italian Data Protection Authority has provided clarifications on the processing of health data by means of a note issued on March 7, 2019.

On the basis of section 9.2 letter h) and section 3 of GDPR, the Authority has indicated that healthcare professionals who are subject to a duty of confidentiality (or other professionals also subject to confidentiality obligations) will no longer require consent of the patient in order to process data for the purpose of providing healthcare services.

Processing of personal data beyond what is necessary to provide healthcare services will, instead, continue to require the patient’s express consent. Consent is required, for example, for the use of medical apps, for any use of personal data for marketing purposes and for the inclusion of data in electronic health records.

In any case, the patient must receive information about how her/his data will be processed (including the duration of the data processing). The Data Protection Authority clarified that such information must be concise, transparent, intelligible and easily accessible, using simple and clear language. For hospitals processing data in complex ways, the Authority suggests that information is given to interested data subjects and when necessary (mass information to all is not a good idea).

Lastly, the Authority notes that the appointment of a Data Protection Officer is required in case of large scale processing of health data, which occurs in hospitals (regardless of their public or private nature), but does not apply to individual medical professionals, pharmacies or orthopedic firms. The keeping of a register of processings, instead, remains a key requirement and a basic element of accountability and risk management in any case of health data processing.

A summary of the Authority’s clarifications can be found here.

G7 Health Summit Closed Today in Milan

On November 5 and 6 the G7 Ministerial Meeting on Health was held in Milan. The meeting had an ambitious agenda, ranging from the impact of climate change on people’s health to antibiotic resistance.

According to the Italian Ministry of Health, hosting the summit on the occasion of the 2017 Italian G7 presidency, the meeting innovated in the way matters have been examined and discussed, by using a so called Delphi method based on the opinions of the world’s leading experts.

A number of satellite events have also taken place across the city, including a conference organized by police forces to address the cross-border fight against “pharmaceutical crime” in all its forms, identifying the critical factors and common responses. The conference focused on the strategies and international collaborations needed to crack down on counterfeit pharmaceutical products, as well as the import and on-line sales of unauthorized products.

Another satellite event focused on the employment of new technologies in the healthcare sector, with particular emphasis on sustainability. Antibiotic resistance has also been a key item on the agenda. Italy is among the countries in the world where deaths linked to antibiotic resistance are higher.

Italian authorities did not conceal that one of the hidden goals of the summit was for them to lobby for the relocation of the European Medicines Agency- EMA headquarters to Milan. The political battle among candidate cities is about to get more intense, as a decision is expected to be adopted before the end of November.

More information on the agenda and materials of the summit can be found here: http://www.g7italy.it/en.

Medical Malpractice in Italy: New Promises for Old Issues

On February 28, 2017, the Italian Parliament approved a long-awaited act, aimed at providing new tools to improve the quality of health care services and to fight the downsides of the so-called defensive medicine.

The act has been proposed and announced as a historical step for Italian health care legislation by Federico Gelli, head of the health care committee of the Italian Democratic Party.

The bill, in its 18 articles, offers a new comprehensive regulation of major aspects of medical malpractice and related issues, such as litigation management and insurance.

  • Article 2 and 3 introduce new administrative authorities: the health protection authority and the national observatory on health care good practices;
  • Article 5 formalizes and regulates the publication of guidelines and good practices for better visibility and increased certainty;
  • Articles 6 and 7 (re-)define the nature and limits of criminal, contractual and tortious liability of health care professionals and hospitals;
  • Article 8 introduces compulsory ADR mechanisms to reduce (discourage?) court litigation;
  • Article 10 establishes insurance obligations for public and private hospitals and health care professionals;
  • Article 12 allows direct compensation from insurance companies to victims of medical malpractice;
  • Article 14 creates a guarantee fund for medical malpractice victims.

Everything looks very promising, at first, but medical malpractice is a too delicate and too complicated subject to think that a simple act could really solve all the outstanding issues.

For example, Italian lawyers and health care professionals certainly remember the goofy attempt to limit health care professionals’ liability by the Italian legislator in 2012 that was not upheld by Italian courts’ decisions, thus nullifying the legislator’s intentions.

From another angle, compulsory ADR mechanisms and insurance obligations always carry the risk to become an obstacle to the effectiveness of the rights of individuals, if not a gift to insurance companies.

Lastly, it is worth noting that the ambitious goals set forth by the Italian legislator would have to be achieved without any additional public investment, as article 18 of the act expressly prohibits such spending. Indeed, it is hard to predict whether a true improvement of health care safety is achievable – automatically and free of costs – just because of a new bill.

In order to have a better understanding of the true potential of the new legislation, stay tuned for more reflections, which will appear on this blog.

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

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.

 

 

Health Innovation Academy: a new event coming up!

The next event of Health Innovation Academy will take place on February 19, 2015 in Milan.

We will discuss how technological innovation reaches patients, with a focus on medical devices within the Lombardy healthcare system.

For more information on the event: http://healthinnovationacademy.weebly.com/come-giunge-linnovazione-tecnologica-al-paziente.html