Gender medicine. We need a law

An interview with Paola Boldrini

You personally followed much of the legislative process on Gender Medicine. Could you briefly tell us what has been done so far by the Italian Parliament, and what the starting point was?

To prepare my bill, I researched parliamentary records to understand what had already been done: in other words, which documents and provisions had been approved on this issue. One of the most important documents, in my opinion, dates back to 2008, the year of publication of the first Report on the work of the “Women’s Health” Committee, established by the then Health Minister Livia Turco, who chose to chair it herself. The publication of this Report was useful as a means to take stock of the situation with regard to Italian women’s health. After this, motions requesting the Government to make a commitment were put forward and voted unanimously, both in the Senate and in the Chamber of Deputies. One of these, dated 2012, also lists the major steps that led to the initiation of research studies, which are increasingly highlighting differences or in some cases confirming unexpected similarities.

The 2012 Motion committed the Government to

1. include Gender Medicine within the National Health Plan;

2. promote Gender Medicine applications, strengthening them consistently throughout the national territory;

3. promote “gender medicine” as a teaching subject in medicine and surgery, nursing and other healthcare Degree programs, in order to foster interdisciplinarity and awareness of the importance of gender medicine;

4. identify healthcare pathways that take into account gender considerations.

The Motion emphasized the importance of prevention and early diagnosis, suggested tax incentives and research studies that take into account gender and sex differences; it encouraged information campaigns to improve knowledge on sex and gender differences. Lastly, it advocated the creation of a National Gender Medicine Observatory in collaboration with the National Institute of Health.

Two bills with the same title (“Provisions on Gender Medicine”) were introduced in 2013 by two of my colleagues at the Chamber of Deputies. Their first signatories were Delia Murer and Pierpaolo Vargiu, respectively, and their texts were very similar, with few changes, to the Motion passed in 2012.

The stated intent was to identify provisions aimed at “recognizing gender medicine”, from an appropriateness perspective. Unfortunately, a parliamentary procedure to see these bills through was never started.

What are the key points of the bill submitted by you and signed by many figures of Italian politics?

The bill sets out in detail how the Minister of health, in consultation with the Regions, should include among the objectives of the Agreement for healthcare the support to Gender Medicine as interdisciplinary approach to the different medical areas, by promoting:

a. biomedical, pharmacological and socio-psychological research projects, selected by conducting national calls and financed by the State;

b. biomedical, pharmacological and socio-psychological research projects, to be assessed by the Ethics committees for regional and local research;

c. adoption of gender-focused guidelines for clinical practice in the different diseases;

d. adoption by local healthcare units and hospitals of Gender Medicine educational, training and clinical objectives;

e. awareness raising actions with scientific journals to promote the accreditation of gender-focused publications.




Additionally, with the assistance of Agenas, the Minister of health shall promote the development and implementation of regional prevention and healthcare plans that take gender into account; establish public registries of gender-based violence; establish that gender be considered as both a clinical and an organizational indicator to be included into the quality assessment plans of local health agencies and hospitals; and instruct the Conference of regions Health commission to conduct systematic analyses on the issue.

Moreover, after receiving the opinion of AIFA (the Italian Medicines Agency), the Minister of health shall issue appropriate guidelines recommending that clinical trials of drugs and medical devices be conducted on population samples selected on a gender equality basis. The bill also provides for the establishment of a dynamic National observatory for gender medicine, with the task to collect, coordinate and transfer epidemiological and clinical data in order to ensure the achievement of equality in the right to health.

Article 5 addresses the issue of training. It sets out that the Minister of health, in consultation with the Minister of education, should prepare a National training plan for gender medicine, involving the implementation of interdisciplinary courses aimed at the knowledge and application of a sex and gender difference-oriented approach in research, prevention, diagnosis and treatment.

Under article 6, the Minister of labour, in consultation with the Minister of health, shall carry out an assessment and possible revision of current regulations on workplace safety from a gender perspective.

Article 7 states that the Minister of health, subject to the opinion of the National institute of health and in collaboration with Agenas, the healthcare agencies and the associations and foundations operating in the field of gender medicine, shall promote scientific information and education initiatives on gender medicine at the local, regional and national level.

What are the purposes of this bill? What are the objectives it aims to achieve?

This bill indicates specific provisions to achieve the practical dissemination of Gender Medicine, such as inclusion in the Agreement for Healthcare, the preparation of Healthcare Agencies and Hospitals/Universities’ Health Plans, and the development of Training Plans, with specific and binding milestones. It aims to help the actions currently in place in Italy go beyond reliance on volunteer work and patchy dissemination, and to constitute a concrete, proactive tool to ensure equality and appropriateness in the exercise of the right to health. It is intended to acknowledge the scientific evidence, by now irrefutable, confirming the sexual and gender differences existing between males and females. It struck me as interesting that even the most prestigious scientific journals now denounce the systematic undertreatment of women with regard to heart disease, as well as the underestimation in men of aspects such as the consequences of femoral fracture. Based on this awareness, the bill intends to achieve a widespread acknowledgment, throughout the country, of the new approach in clinical practice. This aspect is also related to the appropriateness of treatment, and recalls the need for equal respect for the right to health of all men and women.

A significant step forward has been made with the recent introduction of Gender Medicine in Medicine and Surgery Degree programs. What to expect for the future? What are, in your opinion, the prospects of this bill and what is the possible time frame?

Pending the beginning of the bill’s parliamentary process, given the pre-eminent importance of medical training in gender medicine, we have agreed on the need for a Pilot project which, rather than specific “professorships”, provides for gender-oriented contents and data in at least one course of each year of medical school from Academic year 2017-18.

This insight is important, because we have to think about the training of future generations of doctors: if gender-oriented training is available to them from the very beginning of their university education – which is already the case in some Universities – they will not be forced to fill a gap later, like the professionals who are already working.

The pilot project was launched by Andrea Lenzi, President of the National University Council and of the Conference of Presidents of Medicine and Surgery Degree Program Councils and by myself during a meeting that was held in Rome, also attended by Stefania Basili, Vice President of the Conference and Professor at Rome’s Sapienza University and University of Ferrara, Tiziana Bellini, President of the Degree Course in Medicine and Pro-rector for teaching affairs of the Biomedical area of the University of Ferrara, and Fulvia Signani, Psychologist of the Local Health Agency of Ferrara and Adjunct professor at the University of Ferrara. The meeting was held to determine how to plan the practical and timely implementation of the teaching of gender-oriented medicine in Italian Universities, starting with Medical schools..

The proposal of the pilot project was approved by unanimity on December 12, 2016 during the Permanent Conference of the Presidents of Councils of Specialist Degree Courses in Medicine and Surgery.

The primary aim of the study project is to promote awareness among younger generations of physicians. The adoption of a structured gender-specific approach, as part of the educational process in degree courses in Medicine and Surgery, is therefore of utmost importance.

Besides Rome’s Sapienza University and University of Ferrara, several universities joined the project, including those of Palermo, Naples’ Federico II, Campobasso and Foggia. It would be highly desirable the participation of all degree courses in Medicine and Surgery of all the Italian universities.

This idea was suggested, among others, by the fact that, as regards the bill’s parliamentary process, I don’t expect it to be discussed and approved in a short time, whereas I believe it is more urgent than ever to do something practical, at the national level, for the training of future doctors, so as to avoid the risk that politics may be unable to accompany and support the development of society, which is what it should do by its very nature.

At European and international level, what is the legislative situation with respect to Gender Medicine?

While preparing the material to draw up the text of my bill, I tried to explore what had been done, from a regulatory point of view, at the international level.

Through the Parliament Offices, I requested a search of the laws in place abroad, to compare them against my bill: it emerged that at European level there are no existing provisions on gender medicine, or even bills to be examined by the respective Parliaments.

In some other Countries, e.g. Germany, Holland and Sweden, there are actions, such as clinical and pharmacological research studies or gender medicine courses, but no Country has a law under which these actions are carried out.

Therefore I was pleased when, last July, during a hearing I attended before the Foreign Affairs Committee in collaboration with Agenda 2030 (the working group on women’s rights and global health) and the women Members of Parliament intergroup representing all parties present in Parliament, we had the opportunity to meet Dr. Flavia Bustreo, Deputy Director General of WHO’s Family, Women’s and Children’s Health Cluster, and on that occasion I gave her my bill so that it could be used as a source of ideas for similar initiatives. Dr. Bustreo accepted and expressed the hope that a dialogue could be opened with the Italian Parliament, leading to concrete partnerships aimed at improving the health of women in particular, and therefore of the whole family.

Interview by

Mariapaola Salmi