After a long journey that began in 2018, yesterday, the Italian Parliament gave its final approval to the draft law on 'Provisions on the transparency of relations between manufacturing companies, healthcare professionals and healthcare organisations', the so-called 'Sunshine Act'. The text has now to be promulgated by the President of the Republic, before being published in the Official Journal.

 The entry into force of the law will be followed by a transitional period, so that those involved can prepare to fulfil their obligations under the law.

 Here are the main contents of the Sunshine Act.

 Aims pursued and actors involved

The Sunshine Act is aimed at guaranteeing the right to knowledge of relationships of economic importance or advantage, existing between, on the one hand, the so-called manufacturing companies, i.e. the subjects, including those belonging to the Third Sector, that carry out an activity directed to the production or marketing of medicinal products, instruments, equipment, goods and services, including non-health products and  nutritional products, marketable in the field of human and veterinary health, or to the organisation of conferences and congresses concerning such objects, and, on the other hand, the subjects operating in the health sector and health organisations, including any public or even private legal person that provides health services, as defined by Article 2 of the law (Article 1).

 Subject of communications: grants, conventions and agreements

They will be subject to communication:

 1) conventions and payments in cash, goods, services or other benefits made by a manufacturing company in favour of a subject operating in the health sector (if they have a unit value of more than EUR 100 or a total annual value of more than EUR 1,000) or a health organisation (if they have a unit value of more than EUR 1,000 or a total annual value of more than EUR 2,500), and

 2) agreements between manufacturing companies and organisations that produce direct or indirect benefits, consisting in participation in conferences, training events, committees, advisory bodies or scientific committees or in the establishment of consultancy, teaching or research relationships.

 The communication must be made within the six-month period following that in which the disbursements were made and/or the agreements and conventions were entered into and, if the manufacturing company is based abroad, the fulfilment may be carried out by its representative in Italy (Art. 3).

 Subject of disclosures: shares, bonds and incomes from industrial and intellectual property rights

There is also an obligation for manufacturing companies to report, by 31th January of each year, the data of subjects operating in the health sector and health organisations that

 1) are holders of shares in the company's capital or of bonds issued by the company, registered for the previous year in the register of shareholders or in the bond register, or who

 2) have received royalties from the company in the previous year for the granting of licences for the economic use of industrial or intellectual property rights (Art. 4).

 Telematic public register

Within six months following the date of entry into force of the Sunshine Act, a public electronic register called 'Transparent Healthcare' must be set up, in which the aforementioned notifications will be published, as well as the acts imposing the sanctions provided for by the law (Art. 5, paras. 1 and 2).

The electronic public register will be freely accessible by anyone for consultation and will be equipped with functions allowing the search and extraction of the data communicated by the manufacturers (Art. 5, para. 3).

Notifications will have to be submitted electronically in accordance with the instructions that will be determined by the Ministry of Health within three months following the date of entry into force of the law (Art. 5, para. 7).

 “Right to be forgotten”

Notifications published in the electronic public register will be available for consultation for a period of five years following the date of publication, after which they will be deleted (Art. 5, para. 4).

 Consent to publication and rights of the data subject

Consent to the publication and processing of data is considered to be given when the relationship from which the obligation of transparency derives is established. Manufacturing companies will in any case be required to provide appropriate information, specifying that the communications required by law will be published on the institutional website of the Ministry of Health. The law is in any case without prejudice to the rights of data subjects provided for in Articles 15, 16, 17, 18, 19 and 21 Reg. (EU) 2016/679, i.e. the right of access, the right to rectification and the right to erasure of subject's personal data, as well as the right to restriction of processing and the right to object to processing (Art. 5, para. 6).

 Sanctions

Administrative pecuniary sanctions shall be applied in the cases of failure to communicate, communication of incomplete information and communication of false information against manufacturing companies as the parties responsible for the truthfulness of the data contained in the communications (these sanctions will be reduced by half for companies with an annual turnover of less than one million euro provided that they are not controlled by, connected to or bound by supply or subcontracting relationships with other manufacturing companies).

The Ministry of Health is responsible for supervising the implementation of the law and enforcing sanctions (Art. 6).

 Transitional period

The reporting obligations set forth in Article 3 shall apply as from the second six-month period following the six-month period in progress on the date of publication in the Official Journal of the notice in which the Ministry of Health shall communicate the date of commencement of operation of the online public register, while the reporting obligations set forth in Article 4 shall apply as from the second year following the six-month period in progress on the date of publication in the Official Journal of the same notice