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The Italian State Council decision concerns government inaction and the applicability of tacit consent to changes made by pharmaceutical companies to homeopathic medicines. In this article:
This case concerns a homeopathic medicine designed to regulate and alleviate possible hot flashes resulting from menopause and possible sleep and circulation disorders.
The manufacturer had made some changes to the qualitative and quantitative characteristics of the product, as well as to its mode of administration.
After notifying the Italian Drug Agency (AIFA) of these changes, the pharmaceutical company had relied on the tacit consent of the competent authority (as provided for in Article 52, paragraph 15, of Law No. 289 of December 27, 2002) and had proceeded to market the drug.
However, the Italian Drug Agency (AIFA), after the deadline had passed, had ordered the withdrawal of the homeopathic medicine from the market, claiming that the modifications did not comply with the provisions of Article 35 of Legislative Decree No. 219/2006 for traditional medicines.
Article 52, Paragraph 15 of Law No. 289 of December 27, 2002 refers to the special rules applicable to homeopathic medicines. Specifically, Paragraph 15 stipulates that, for homeopathic medicines without specific therapeutic indications, changes to qualitative and quantitative characteristics, as well as to the mode of administration, are subject to tacit consent by the competent authority.
For example, changes to the homeopathic medicinal product could concern:
changes in the primary packaging;
quantity of the contents;
variation of one or more dilutions of the starting material(s) as long as the new dilution is higher than the previous one;
replacement of a component with a similar one;
elimination of one or more components;
variation of the marketing authorization holder;
variation of the trade name;
variation of the manufacturing site;
variation of the manufacturer.
This means that the holder of the AIC marketing authorization for a homeopathic medicine, i.e. the pharmaceutical company, can implement the changes in product characteristics without waiting for explicit approval from the authority. If the authority fails to make a decision within a specified period, the application is considered to have been tacitly granted and the changes can be made.
This special regulation was introduced precisely to take into account the peculiarities of homeopathic medicines, which differ from traditional medicines in their characteristics and mode of action. It is a significantly more flexible regulation than Article 35 of Legislative Decree No. 219/2006, which provides for a more stringent authorization process and applies for changes to traditional medicines
Before continuing with the analysis of the Italian State Council decision, it is important to clarify some basic notions. The Marketing Authorization (MA, AIC) is a document issued by the competent authority, in Italy the AIFA, which certifies the quality, safety and efficacy of a medicine and allows its sale and distribution in the national territory.
Regarding the difference between traditional and homeopathic medicines, it is essential to note that they have different characteristics in terms of composition, active ingredients, mechanism of action, and regulation. The Marketing Authorization (MA) covers both types of medicines, i.e. traditional medicines and homeopathic medicines. However, as mentioned earlier, the regulations and requirements for obtaining MA for the two types of drugs differ in some significant aspects.
For traditional drugs, the process of obtaining the MA requires the submission of data and clinical studies demonstrating the quality, safety and efficacy of the drug. AIFA carefully evaluates this information and, if it finds that the medicine meets the necessary requirements, issues the MA, which allows the medicine to be sold and distributed in the country.
For homeopathic medicines, the process of obtaining the MA is different and follows specific regulations. In particular, homeopathic medicines are not required to demonstrate their therapeutic efficacy through clinical trials to obtain authorization. However, they must still meet quality and safety requirements, and must be produced in accordance with standards set by the competent authorities.
Article 35 of the Italian Legislative Decree No. 219/2006 concerns “Variations in the qualitative and quantitative characteristics of medicinal products, as well as their mode of administration” and applies only to traditional medicines.
In Italian State Council Decision No. 2434/2023, the reference to Article 52, paragraph 15, of Law No. 289/2002 was made precisely to point out that the special regulations for homeopathic medicines do not contain provisions similar to those dictated by Article 35 of Legislative Decree No. 219/2006, invoked by AIFA.
The State Council concluded that the recall order for the homeopathic medicine in question was unjustified. The State Council referred to Article 52, paragraph 15, of Law No. 289 of December 27, 2002, which specifically regulates homeopathic medicines and does not contain provisions similar to those in Article 35 of Legislative Decree No. 219/2006, invoked by AIFA. The latter article would impose an obligation on the applicant to make the required changes within the timeframe provided by Regulation (EC) No. 1084/2003.
In particular, it regulates the procedures that pharmaceutical companies must follow when they want to make changes to the characteristics of already authorized medicines.
The main provisions of Article 35 stipulate that:
Depending on the category of variation, there are different approval procedures and different deadlines for fulfilling the required formalities. For type IA and IB variations, the authorization holder must notify the competent authority within a certain time period, while type II variations require a formal application for authorization.
AIFA had invoked Article 35, arguing that the company should have modified the homeopathic drug within the time limits set by Regulation (EC) No. 1084/2003. However, the Italian State Council noted that this article is not directly applicable to homeopathic medicines, as there is a special regulation for the latter in Article 52(15) of Law No. 289 of December 27, 2002.
The State Council points out that it is not reasonable to challenge, years later, the effects produced by the “tacit consent” formed on the petitions submitted by the appellant company. The State Council clarified that “it is not reasonable now, several years later, to question the effects produced by the tacit consent formed on the applications and to think of thus remedying the failure of the public administration to promptly exercise the power of denial that is its responsibility to the detriment of the appellant company, which has merely scrupulously adhered to what had been tacitly authorized, in deference to the invoked special regulations dictated, for homeopathic medicines, by Article 52, paragraph 15, of Law No. 289 of December 27, 2002. Indeed, this is a regulation that, as pointed out by the appellant’s defense, does not contain provisions similar to those dictated by Article 35 of Legislative Decree No. 219/2006, invoked by AIFA, which would instead have required, as already noted, “the applicant to proceed with the amendment once the terms provided for by Regulation (EC) No. 1084/2003 have expired“.
The impact of this ruling mainly affects the homeopathic drug sector, influencing how manufacturing and distribution companies operate in terms of authorization and modification of their products.
The decision reinforces the principle of tacit consent in public administration, providing greater legal security for companies that operate in the homeopathy sector and scrupulously adhere to current regulations.
The Canella Camaiora Law Firm is dedicated to providing legal advice and assistance in industrial law, both with regard to traditional and homeopathic medicines. Thanks to the experience and expertise of the firm’s professionals, we are able to offer support to companies in handling issues related to the authorization, marketing and promotion of their products, ensuring compliance with current regulations and the protection of their interests.