Summarize the rules for advertising and promoting drugs and medical devices, explaining when the provision of information will be considered promotional. Are there special rules for online advertising?
Drug advertising is defined as any information, client-seeking or exhortation action intended to promote the prescription, supply, sale or consumption of drugs. The legal definition of advertising for medicines is interpreted broadly both by the health authorities (the Italian Medicines Agency (AIFA) and the Ministry of Health (MoH)) and by the courts.
Information on medicines is qualified as advertising if, by virtue of its purpose, content or context, it encourages the target audience to prescribe, supply or purchase a medicine. This is not the case for purely societal or financial information describing the field of activity of a company and the progress of research.
Advertising of unauthorized drugs or unauthorized indications is always prohibited.
The advertising to the general public of drugs available only on prescription or containing substances defined as psychotropic or narcotic is also prohibited.
Advertising of over-the-counter drugs to the general public requires prior authorization from the Department of Health.
As for advertising intended for healthcare professionals, any document or material relating to a medicinal product, with the exception of the authorized summary of the characteristics of the product, must be submitted to the IAAF before the start of the advertising campaign and may be provided to the doctor by the pharmaceutical company if, within ten days of the filing date, the IAAF has not raised any objection.
The Department of Health has adopted specific guidelines on online advertising of non-prescription drugs.
Advertising of medical devices which, according to the indications of the Ministry of Health, can only be supplied on medical prescription or can be used with the assistance of a doctor, is prohibited.
Advertising of other medical devices requires the prior authorization of the Ministry of Health.
The Ministry of Health has adopted specific guidelines on online advertising of medical devices.
What regulations exist to discourage the inducement of healthcare professionals to prescribe, sell, supply or recommend the use of a particular drug or medical device?
Pharmaceutical companies and manufacturers of medical devices must comply with general anti-corruption rules (Legislative Decree No. 231/2001).
Under the drug code, in the context of the promotion of drugs to health professionals, it is forbidden to grant, offer or promise prices, pecuniary benefits or in kind, unless they are of value. negligible and are, in any event, linked to the activity carried out by the doctor or pharmacist. The value is negligible if it does not exceed 20 € per year for each doctor or pharmacist.
In addition, any person who promises or gives a sum of money or any other advantage to a doctor or a pharmacist in order to encourage them to prescribe or dispense a drug is liable to imprisonment and a penalty. pecuniary (royal decree n ° 1265/1934).
If this is done by a pharmaceutical company, the Ministry of Health can decide to close the business of the company.
Declaration of value transfers
What requirements apply to the recording and publication of details of transfers of value to healthcare professionals and organizations by companies marketing drugs or medical devices?
Companies marketing drugs or medical devices that have hired healthcare professionals who work in the public sector for the provision of paid services are required to disclose the amount of remuneration paid for services rendered to the relevant public entity in 15 days after payment (Legislative Decree 165/2001).
In the context of clinical trials on medicinal products, the principal investigator is required to declare to the clinical center the absence of any advisory relationship or other contractual relationship with the pharmaceutical company sponsoring the clinical trial (legislative decree n ° 52/2019).
Industry self-regulation codes impose on companies marketing drugs or medical devices the obligation to disclose the details of value transfers to healthcare professionals or healthcare establishments (Farmindustria, Assogenerici and Confindustria Dispositivi Medici codes of conduct ).
Application of advertising rules
Describe the bodies involved in the monitoring and compliance with advertising controls for medicines and medical devices, distinguishing any framework for self-regulation and control by the authorities.
The Italian Medicines Agency (AIFA) and the Ministry of Health are responsible for monitoring and ensuring that advertising of medicines and medical devices complies with all legal requirements. Their decisions can be challenged before the competent judicial authority.
What are the possible financial or other penalties for violating advertising and promotional controls for drugs or medical devices?
If the advertising of medicines to healthcare professionals does not comply with the legal requirements set out in the Medicines Code, the Italian Medicines Agency (AIFA) can:
- order the immediate cessation or suspension of the dissemination of the promotional message; Where
- order the dissemination, at the expense of the responsible company, of a press release in order to rectify the illicit promotional message.
Likewise, the AIFA may prohibit the holding of a promotional event if it does not meet the requirements set out in the Medicines Code.
In addition, violation of the rules relating to advertising addressed to healthcare professionals may be punished by an administrative penalty ranging from € 2,600 to € 15,600.
If the advertising of medicinal products intended for the general public does not comply with the requirements set by the drug code, the ministry responsible for health can:
- order the immediate cessation of advertising; Where
- order the dissemination, at the expense of the responsible company, of a press release to rectify the illicit promotional message.
In addition, the Ministry of Health may apply an administrative penalty to the subject company ranging from € 2,600 to € 15,600.
Advertising of medical devices not authorized by the Ministry of Health is punishable by a fine ranging from € 2,582.26 to € 15,493.71 (Royal Decree No. 1265/1934).
Pricing and reimbursement
What controls are imposed on the pricing of drugs and medical devices and on reimbursement by national social security systems applicable to manufacturers, distributors and pharmacists?
The ministerial decree of August 2, 2019 regulates negotiations between the Italian Medicines Agency (AIFA) and pharmaceutical companies for the pricing and reimbursement of medicines.
The Scientific Technical Committee (CTS), AIFA’s technical advisory board, assesses the clinical value of the drug and its therapeutic added value with regard to similar products already on the market.
The Pricing and Reimbursement Committee, which is responsible for agreeing the price, based on the assessment of the CTS, conducts the negotiation with the pharmaceutical company, taking into account other elements constituting the costs of the therapy versus pharmacological therapies already available, the expected number of treatments and the costs paid by the National Health System (NHS).
NHS hospitals are supplied by tender, but a mandatory discount is usually requested by hospitals.
The negotiation process must be completed within 180 days.
The supply of wholesalers and pharmacies is carried out at the negotiated price, with special discounts.
For generics and biosimilars, to avoid negotiation with the AIFA, the MA holder must apply a price lower than that of the originator in an amount acceptable to the AIFA.
Sale and supply
Are there specific rules governing the supply or sale of particular types of drugs or medical devices?
There are specific rules governing the issuance and sale of blood derivatives, such as Law No. 219/2005 on transfusion activities and national production of blood products. The therapeutic use of cannabis is also regulated by specific laws (law 242/2016, decree of the Ministry of Health of November 16, 2020).
What laws and guidelines govern the dispensing, sale and online supply of medicines and medical devices?
According to article 112-fourth of Legislative Decree No. 223/2006, the remote supply of medicines issued only on prescription to the public is prohibited. The online sale of non-prescription drugs is authorized under certain conditions.
Pharmacies and parapharmacies operating on Italian territory can sell non-prescription drugs online provided they have been authorized by the competent regional authority and have obtained from the Ministry of Health the common logo which must be affixed to the site. Web used to perform such activity.
The online sale of medical devices is authorized by online pharmacies operating legally but also by third-party marketplaces, provided that post-marketing surveillance is ensured.