Homeopathy does not need evidence; a law is enough

During the 19th parliamentary term, several initiatives were launched aimed at broadening public recognition of homeopathy and so-called complementary therapies. Bill S.1251, tabled by the Five Star Movement, provides for such practices to be considered therapeutic, to be used within the National Health Service and to form part of university courses leading to professional qualifications. During the examination of the government’s Bill S.1786 on pharmaceutical legislation, a number of senators from Forza Italia, the League and the Five Star Movement also attempted to include explicit references to homeopathic and anthroposophic medicines. In addition to these parliamentary initiatives, the Undersecretary of State for Health, Marcello Gemmato, has publicly supported the need to review Italy’s regulatory framework for homeopathy. The central issue concerns the distinction between ‘therapeutic value’, ‘therapeutic effect’ and ‘therapeutic efficacy’. Bill S.1251 uses the wording that the Republic ‘recognises the therapeutic value’ of complementary and integrative therapies. This is an attribution made through legislation. In medicine, however, the therapeutic effect is an improvement brought about by treatment, which must be distinguished from the spontaneous course of the disease and from the placebo effect through controlled trials. Documented therapeutic efficacy requires that such an improvement emerges reliably, is reproducible and is superior to that observed in patients receiving a placebo or a comparator treatment. The bill replaces this verification with a general recognition established by Parliament. A law may regulate the sale of a product, determine who may administer it and decide whether to fund it with public money. The same law cannot prove that the product cures a disease, because this is an empirical matter that depends on the results of clinical trials. When the legislator attributes ‘therapeutic value’ to a practice without requiring proof of its efficacy, it confers a legal status that citizens may easily interpret as scientific certification.

Homeopathy has been the subject of repeated scientific evaluation. In 2017, the European Academies’ Science Advisory Council, which brings together the national scientific academies of the European Union member states, reviewed the main available systematic reviews and concluded that there is no condition for which robust and reproducible efficacy superior to placebo has been demonstrated. The same body noted that the mechanisms proposed by homeopathy are incompatible with established knowledge regarding the relationship between dose and pharmacological effect. Many homeopathic products are diluted to such an extent that they no longer contain any molecules of the original substance, whilst the alleged ‘memory of water’ has not been confirmed by experiments consistent with the claimed clinical effect. On this basis, the European academies have recommended that public health systems should not reimburse homeopathic products and services in the absence of rigorous evidence of efficacy. European legislation on homeopathic medicinal products does not alter this conclusion. Article 14 of Directive 2001/83/EC allows for simplified registration of sufficiently diluted products intended for oral or external administration and without therapeutic indications. This procedure expressly exempts the product from the requirement to demonstrate efficacy. The product may therefore be registered as a ‘homeopathic medicinal product’ because it meets certain manufacturing and safety requirements, without it having been demonstrated that it cures a specific disease. The same distinction is set out in Legislative Decree 219 of 2006, by which Italy transposed the European legislation. AIFA assesses the pharmaceutical quality of the product and the aspects necessary for its registration, but the simplified procedure does not certify therapeutic efficacy and requires the absence of approved indications. The term ‘medicinal product’ therefore refers to a legal and manufacturing category; it does not constitute proof of clinical efficacy.

The request put forward by homeopathic companies concerns precisely this restriction. On 28 April 2026, Omeoimprese, an association representing Italian manufacturers and distributors of homeopathic and anthroposophic medicines, was heard by the 10th Senate Committee during the examination of Bill S.1786. Chairwoman Silvia Nencioni called for the reform to fully recognise the specific nature of these products and to allow for communication relating to the individual medicinal product, its dosage and its scope of use. She also criticised the interpretation adopted by AIFA, which she deemed too restrictive as it prevents therapeutic indications not supported by a standard authorisation based on clinical evidence from being associated with the products. A few months later, on 14 July 2026, the Senate hosted the conference ‘La medicina omeopatica in Europa e in Italia. Quadro normativo, orientamenti e prospettive di riforma’, organised by Senator Giovanni Satta of Fratelli d’Italia. Satta is also the rapporteur for S.1251. The meeting was attended by Undersecretary Gemmato, who argued for the need to bring Italian regulations into line with those of other European countries and to provide more comprehensive information on homeopathic medicines, starting with the patient information leaflet. He explained the Government’s interest by pointing to the more than ten million citizens who report having used these products in the last year and noted the existence of a consultation forum at the Ministry of Health. The number of consumers reflects the commercial prevalence of the product, not its therapeutic effect. Widespread use may necessitate careful monitoring of production and the accuracy of information, but it cannot prove that patients improve as a result of the treatment. Efficacy requires a comparison between groups of patients and the measurement of pre-defined clinical outcomes. Popularity does not provide this data.

The request to expand the package leaflet must therefore be assessed on the basis of its content. The addition of information on composition, dilution ratio or precautions may improve transparency. The inclusion of treatable conditions, therapeutic dosages or clinical benefits, on the other hand, would attribute to the product a level of efficacy that should be demonstrated through appropriate studies. In this second case, the package leaflet would become the means by which a public authority confers clinical value on data that has not met the standard evaluation criteria. The impetus from the Government is evidenced by the public stance taken by Gemmato, whilst the legislative initiatives tabled so far have originated in Parliament. The documents do not reveal a formally uniform line across the entire Executive, as the Government has expressed opposition to one of the amendments to S.1786. The fact remains that an Under-Secretary of State for Health took part, in an institutional setting, in a meeting dedicated to the reform of homeopathy and presented the sector’s requests as an issue warranting regulatory intervention. The first explicit attempt to amend the legislation took place during the examination of S.1786, a bill through which the Government is asking Parliament for delegated powers to reorganise pharmaceutical regulations. Following the hearing with Omeoimprese, three political groups tabled almost identical amendments to ensure that the delegated powers would also cover “homeopathic and anthroposophic medicines governed by current legislation”.

Amendment 3.14 was tabled by Daniela Ternullo and Francesco Silvestro of Forza Italia. Amendment 3.15 was tabled by Orfeo Mazzella, Barbara Guidolin and Mariolina Castellone of the Five Star Movement. Amendment 3.16 was tabled by Elena Murelli, Tilde Minasi and Maria Cristina Cantù of the Lega. The same request therefore appeared in part of the majority and in a section of the opposition. A fourth amendment, 3.150, had been tabled by Mazzella, Guidolin and Castellone. The text called for the reform to ensure the “accuracy of information and the sustainability of the entire homeopathic medicines sector”. The wording combined patient protection with the economic protection of the sector, introducing into the criteria of pharmaceutical legislation the sustainability of a sector whose products have not demonstrated greater efficacy than a placebo. The amendment was rejected, with the rapporteur and the Government voting against it. Amendments 3.14, 3.15 and 3.16 received a negative opinion from the Budget Committee pursuant to Article 81 of the Constitution. In the minutes of 8 July 2026, the rapporteur pointed out that homeopathic medicines are not included in the essential levels of care (LEA), that is, the services that the National Health Service is required to provide through public funding. He therefore observed that the amendments appeared to pave the way for the subsequent inclusion of these products in the LEA, with potential costs for the State.

The dissenting opinion concerned financial coverage and not a lack of efficacy. The reports do not contain a scientific assessment of homeopathy, nor do they assert the principle that a product lacking evidence should not be granted therapeutic indications or public funding. Bill S.1786-A, finalised by the Committee on 14 July 2026, contains no references to homeopathy or anthroposophic medicines. The attempt therefore did not result in legislation, but it did demonstrate that there are senators from Forza Italia, the League and the Five Star Movement willing to include these products in the pharmaceutical reform. Bill S.1251 has a much broader scope. It was tabled on 1 October 2024 by Senator Mazzella of the Five Star Movement and is currently being examined by the 10th Committee in its drafting phase, a procedure in which the Committee carries out the main work on the articles prior to the final vote in the Senate. The rapporteur is Giovanni Satta of Fratelli d’Italia. As of 24 July 2026, only the original text is available and a list of amendments has not yet been published. The text does not expressly mention homeopathy, but its inclusion is certain. The Senate’s official TESEO classification associates Articles 1 and 4 of the bill with the subject of ‘alternative and homeopathic medicine’. During the preliminary examination, the Italian Society of Homeopathy and Integrated Medicine was heard and submitted a written submission on the bill. The State-Regions Agreement of 7 February 2013, used as a reference for training in complementary medicine, also includes homeopathy and treats homotoxicology and anthroposophy as equivalent to it.

Article 1 defines complementary and integrative therapies as those aimed at alleviating physical or psychological suffering, contributing to rehabilitation and enhancing well-being. The definition takes into account what a practice claims to achieve, rather than what it has been shown to achieve. A discipline may therefore fall within this category simply because it claims to have a therapeutic purpose, even where studies have not confirmed any specific clinical effect. Having defined the category on the basis of its stated aims, the article stipulates that the Republic ‘recognises the therapeutic value of complementary and integrative therapies’. This is the decisive provision. Parliament attributes ‘therapeutic value’ by law, whilst therapeutic efficacy should be demonstrated separately for each treatment and for each clinical indication. In the case of homeopathy, legislative recognition would come after leading scientific assessments have ruled out the existence of robust evidence of efficacy superior to that of a placebo. The explanatory memorandum to S.1251 maintains that the bill concerns therapies with documented safety and efficacy that have been approved by international scientific societies. The text of the bill, which constitutes the part intended to become law, does not contain these conditions. No article specifies what level of evidence must be met, what studies must be submitted, or which public body should verify them. No assessment by the Higher Institute of Public Health is required, nor is the mandatory involvement of AIFA or AGENAS provided for. There is also no reference to the procedures of the National Guidelines System. Nor is efficacy linked to any specific indications. A treatment may be beneficial for one condition and ineffective for another, which is why conventional medicines are authorised for specific diseases, dosages and patient populations. Bill S.1251, on the other hand, attributes therapeutic value to the entire category of complementary therapies, without specifying which conditions may be treated or which outcomes should be measured.

Article 1 itself stipulates that these therapies form part of the services provided by the National Health Service and may be administered in hospitals, rehabilitation centres, care homes, educational institutions, prisons and addiction treatment centres. The text does not define the eligible clinical conditions, does not explicitly prohibit the substitution of effective treatments, and does not provide for specific safeguards for vulnerable individuals housed in such facilities. The article does not immediately establish a new Essential Level of Care (LEA) nor does it set a national tariff. Its approval would, however, provide a legislative basis for introducing programmes and services through subsequent ministerial or regional decrees. The formulation stating that these therapies ‘fall within’ the scope of NHS services would also have a strong legitimising effect, as healthcare facilities and professionals could cite a state law that has recognised their therapeutic value. The reference to citizens’ freedom of choice and doctors’ freedom to treat does not resolve the issue. Individual freedom allows a person to purchase a legal product, provided they receive accurate information. Provision by the NHS, on the other hand, requires the State to assess whether that service produces sufficient benefit to justify the use of public resources. Transforming an individual preference into a healthcare service means granting it recognition that must be based on evidence. Article 2 establishes a Permanent Commission for Complementary and Integrative Therapies within the Ministry of Health. Its tasks include raising awareness of these practices, promoting research – including with a view to recognising new disciplines – and assessing qualifications obtained abroad. The Commission should also draw up a code of ethics for experts.

The draft bill does not specify the number of members of the Commission nor does it indicate what scientific expertise they must possess. There are no provisions regarding conflicts of interest, nor is mandatory representation reserved for the public bodies responsible for the assessment of health technologies. The Ministers for Health and Universities would appoint the members, whilst the Commission itself would adopt its own rules of procedure. This structure assigns to the same body the task of promoting therapies and that of overseeing their application. Research is also geared towards the possible recognition of new disciplines, whilst the text does not define a procedure for excluding those found to be ineffective. The composition of the Commission therefore becomes decisive, because a potential predominance of representatives from the disciplines concerned could influence the criteria used to recognise them. Articles 4 and 5 establish the professional role of ‘expert in complementary and integrative therapies’ and provide for registers to be maintained by professional bodies. Registration would allow the title to be used publicly. For members of the public, inclusion in a register maintained by a health professional body normally represents a guarantee of professional competence. In the proposed system, this guarantee would relate to the practitioner’s training, whilst there would be no equivalent verification of the effectiveness of the practice carried out.

Article 6 introduces recognition within the university system. Universities could establish first- and second-level master’s programmes leading to the qualification of ‘expert’, whilst a decree issued by the Ministries of Universities and Health would be required to set out the programmes and subjects. The text also provides for the possibility of authorising private training institutions to award the qualification. A university may legitimately study homeopathy as a historical, social or economic phenomenon. The master’s programmes provided for in S.1251 would serve a professional purpose, as the qualification obtained would be required for registration in professional registers and for practising within healthcare facilities. The university would therefore participate in the training of practitioners to whom the State has recognised the right to practise a discipline considered therapeutic. The minimum requirements are lower than those already established by the 2013 State-Regions Agreement. S.1251 stipulates a duration of no less than one year, comprising at least one hundred hours of theory and fifty hours of clinical practice per year. The current agreement requires, for acupuncture, phytotherapy and homeopathy, at least 400 hours of theory and 100 hours of clinical practice, in addition to independent study and supervised training. It also stipulates a minimum attendance rate of 80 per cent and, for courses delivered by accredited providers, a duration of normally three years.

The project could therefore broaden professional recognition by reducing the minimum training required. This issue is distinct from that of effectiveness: a longer course may improve knowledge of the discipline, but does not make the treatment effective. Reducing the requirements would, however, increase the number of individuals able to present themselves as recognised experts. Article 7 stipulates that the law must be implemented without imposing new or increased burdens on public finances. This clause is difficult to reconcile with the establishment of a standing committee, the promotion of research and the provision of services within the National Health Service (SSN). In the absence of new funding, these activities would have to utilise existing resources, thereby competing with healthcare interventions that have undergone efficacy assessments. The contradiction with the opinion expressed on the amendments to S.1786 is evident. The Budget Committee considered that the mere reference to homeopathic medicines in the pharmaceutical delegation bill could pave the way for their future inclusion in the Essential Levels of Care (LEA). Bill S.1251 explicitly states that complementary therapies form part of the National Health Service’s benefits, whilst declaring that this must not result in additional costs. When the bill is examined by the Budget Committee, it will need to be clarified how this provision can be implemented without affecting healthcare expenditure.

The articles as a whole provide a comprehensive overview. Article 1 attributes therapeutic value and grants access to National Health Service facilities. The subsequent articles establish the role of the expert and the relevant registers, whilst Article 6 provides for university courses and qualifications that may also be awarded by authorised private institutions. Article 2 entrusts a ministerial commission with the task of overseeing the implementation of the system and promoting the recognition of new disciplines. For homeopathy, this framework would make it possible to achieve through a political decision what research has failed to demonstrate. The product would continue to lack robust evidence of efficacy superior to that of a placebo, but the practice could be defined as therapeutic by law, practised by professionals registered in public registers and taught on master’s programmes leading to a recognised qualification. Its potential inclusion within the National Health Service (SSN) would further reinforce the perception that the State has verified its efficacy. The amendments to S.1786 have been put on hold for the time being. Amendment 3.150 was rejected, whilst the Budget Committee’s negative opinion prevented amendments 3.14, 3.15 and 3.16 from being included in the final text. S.1251, on the other hand, remains under consideration and has a broader scope, as it concerns not only the provision of information on homeopathic medicines but also the recognition of practices, professionals and training programmes. Political support for it spans both the majority and the opposition. Satta, a member of Fratelli d’Italia and rapporteur for S.1251, organised the institutional meeting on homeopathy attended by Gemmato. Forza Italia and the Lega have tabled amendments in favour of homeopathic medicines in S.1786, whilst the Five Star Movement has tabled the same amendments and is the author of S.1251. There is not yet a parliamentary majority formally committed to approving the bill, but there is documented convergence among members of different groups.

The issue concerns the criteria by which a practice is incorporated into the public healthcare system. EBM requires that therapeutic efficacy be demonstrated prior to recognition and for a specific clinical indication. Bill S.1251, however, attributes ‘therapeutic value’ by law to a category defined by its stated aims. Scientific evidence thus ceases to be a prerequisite for access to the National Health Service and the university system, whilst political recognition becomes the starting point. The approval of this bill would make it possible to present a practice that has not been shown to produce the promised effect as a recognised therapy. The issue does not concern citizens’ freedom to purchase homeopathic products – which remains guaranteed under current legislation – but rather the use of state authority to confer clinical credibility on those products and the associated practices. Therapeutic efficacy must continue to depend on research findings, because no parliamentary provision can transform the absence of evidence into proof of efficacy.