Elio Rossi, Mariella Di Stefano, Sonia Baccetti, Fabio Firenzuoli, Lorenzo Roti, Monica Da Frè, Martha Perez Viña, Vuk Stambolovich *

Introduction

The World Health Report published in 2008 focused on the need to return to primary treatment to bridge the gap between the rich and the poor in terms of access, effects and costs of health assistance, addressing issues such as child mortality in developing countries; the life expectancy gap between northern and southern countries and Western and Eastern Europe; costs for health care, which contribute to the impoverishment of 100 million people each year; coverage of maternal, newborn and child health interventions (4 women out of 10 are excluded from basic interventions of prevention and treatment). Chronic diseases, difficulty in responding to complex needs, disparity of treatment, the evident relationship between socio-economic conditions and state of health and between individual fragility and social exclusion require a common effort to guarantee universal access to health treatment and to ensure sustainability of public health systems.

The Alma Ata Declaration of 1978, sponsored by WHO and UNICEF, strongly requested that the international community support the inclusion of scientifically-validated traditional and complementary medicine into national health systems. In May 2009 the 62nd World Health Assembly adopted a resolution that is relevant for homeopathy and other therapies in the field of Complementary and Alternative Medicine. The resolution points out the progress that many governments have made to include Traditional Medicine, as well as Complementary and Alternative Medicine (CAM), into their national health systems and that progress in this field has been achieved by a number of Member States through implementation of the WHO traditional medicine strategy 2002–2005. The resolution refers to the Beijing Declaration about Traditional Medicine of November 2008 and the 2008 WHO World Health Report: “Primary health care - now more than ever”. It recognizes traditional medicine as one of the resources of primary health care services that could contribute to improved health outcomes.

Rational and appropriate use of complementary and traditional medicine resources can contribute to reducing drug consumption and therefore public health care costs (Smallwood, 2009). Furthermore, these therapies can help diminish the side-effects of chemical drugs, a world-wide phenomenon in constant growth. Finally, the production and use of traditional remedies can foster the development of local economies, valorizing autochthonous cultures and generating economic activities able to optimize the local resources.

The Tuscany Region represents an interesting case study both regarding the integration of non-conventional medicine in the public regional health care system and because of its long-time experience of supporting the inclusion and the development of Complementary and Traditional Medicine (CTM) through activities of international cooperation. This article aims at discussing the specificities of the Tuscan experience in the integration of CTM both within its territory and in Cuba and Serbia.

Complementary medicine in the Tuscan Public Health System
The integration of non-conventional medicine in the public regional health care system of Tuscany is considered to be the most significant in Italy and can also be considered a reference point in Europe.

Evolution of CM in regional health care plans of Tuscany
The healthcare programmes of the Region of Tuscany have contained references to non-conventional medicine since 1996. The most recent regional health plans have included a chapter about non-conventional medicine that can be considered the greatest degree of integration of these therapies in public health care system achieved so far in Italy. The aim is to guarantee the integration in the Regional Health Service of types of non-conventional medicine supported by a sufficient level of scientific evidence to allow them to be defined as complementary medicine/CM (that is acupuncture, herbal medicine, homeopathy and manual medicine). 1996 to 1998: Preliminary activities The Regional Health Plan 1996-98 contained some regulations to valorise “alternative medicine” and an invitation to look at “all practices of natural medicine and promote a health culture based on a reduction of the consumption of pharmaceutical products”. This issue was first debated at the conference held in Florence in December 1997, sponsored by the Tuscany Region. The aim was to stimulate reflection on disseminating CAM institutionally and provide a response to this phenomenon. The event also called for the definition of programmes to transform the opportunities provided by 1996-98 Regional Health Plan into initiatives and activities. At the same time, and for the first time in Italy this period (1997 to 1999) saw the first projects of Tuscany Region’s decentralised cooperation to support the development of natural medicine and homeopathy in various countries.

1999 to 2004: Complementary medicine takes root in Tuscany’s public health plans
The Regional Health Plan 1999-2001, for the first time in Italy, had a chapter about complementary medicine and how to integrate it into the regional health system. A Regional Commission of experts in CM was also established with the task of studying the strategies to achieve the integration of these medicines. The Commission had to identify instruments to assess the demand for CM in Tuscany and the most significant activities; evaluate proposals for research; define, in agreement with medical associations and universities, criteria for the accreditation of training courses and, finally, set a Register of CM doctors. A further task of the Commission was to provide citizens with information about services and availability of these alternative medicines.

In 1999, the Tuscany Regional Council allocated a special fund to support the development of CM in the regional health service on the basis of projects submitted by local health centres. In the summer of 2001, a resolution supported the scientific research in this area, which allocated specific funds. This enabled public and private institutions and associations in Tuscany to submit research projects to verify the effectiveness of non-conventional therapies in specific illnesses in both humans and animals.

The Regional Health Plan 2002-2004 made it possible to start a phase of more structured inclusion of these medicines in the regional health system; it also included guidelines for general practitioners on the use of CM and for training operators in collaboration with the Tuscan Medical Association (Rossi et al., 2008).

2005-2007: Complementary medicine in Essential Levels of Assistance
The Regional Health Plan for 2005-2007 aimed to integrate CM with sufficient levels of scientific evidence in the regional health service: acupuncture, herbal medicine, homeopathy and manual medicine. These types of medicine have been introduced into regional essential levels of assistance (LEA) establishing an official price list. The plan also approved the inclusion of CM representatives in regional health council working groups, the introduction of regional guidelines when they are recognized as an effective complementary therapy for specific conditions, information in health-related university courses and specific activities that ensure the integration in the regional health system. In fact, it envisages an annual budget of 600 thousand Euros for 3 years to this end.

In September 2006 the Tuscany Region Integrative Agreement about specialist care for outpatients was signed, whichalso included complementary medicine. It provides for the treatment of out-patients also by doctors specialized in complementary medicine. Specialists must have a certificate issued by the provincial medical association proving the successful completion of theoretical and practical training in complementary medicines (acupuncture, herbal medicine, and homeopathy). So far, this is a unique experience in Italy. The Law n.40 that reformed Local Health Centres (2006) provided for the presence of complementary medicine representatives in all the Tuscan health centres (2 per centre), in the regional health Council and the Regional Bioethics Committee.

Complementary medicines have also been included in the official regional price lists since 2005 (Resolution 655 of 20.6.2005). Residents can therefore receive specialist treatments in acupuncture, homeopathy, herbal medicine and manual therapy at the fee of 18,59 Euros. Access to treatments is direct and there is no need to be referred by the general practitioner.

2007-2011 The regional laws on complementary medicine
In spring 2007, the Tuscany Regional Council approved the law that regulates the use of complementary medicine by medical doctors, pharmacists and veterinarians. The legislation states that medical doctors, dentists, veterinarians and pharmacists associations are to draw up lists of professional experts in complementary medicine based on the requirements defined by the Regional Committee for training in complementary medicine, and issue a specific certification. The Regional Committee is made up of representatives of professional associations, CM associations, the region’s universities, the directors of regional centres of CMs and experts. It is the committee’s duty to define the criteria for admission to the list of complementary medicine doctors, dentists, pharmacists and veterinarians, and the criteria for the accreditation of public and private complementary medicine training centres (to be included in the list of the region’s accredited training institutions).

In 2010 Tuscany approved a regional law that regulates the practice of complementary medicine in training centres. Public or private non-university training centres can be accredited according to the Regional Law of Tuscany 9/2007, and the law n.993/2009. To those attending CM courses, accredited training centres can issue a diploma allowing the admission to the list of general, dental, veterinary surgeons and pharmacists.

Educational activities
The process for incorporating complementary medicines in the regional health system was developed in cooperation with the medical associations and universities of Tuscany that have organised activities/courses in this field. The Faculty of Pharmacy of University of Florence set up a course in advanced Chinese Herbal Medicine, the Faculty of Medicine a level II Master’s degree in "Acupuncture and Traditional Chinese Medicine" and a level II Master’s in "Clinical Herbalism”, in collaboration with the University of Empoli. In 2007, the Faculty of Pharmacy of Pisa started a level I Master’s degree in "Medicinal and aromatic plants". The Faculty of Medicine of the University of Siena has set up a Master’s degree in Integrative Medicine. The universities of Pisa and Florence offer degree courses in herbal techniques. A master in Natural Medicine (herbal medicine, acupuncture, manual medicine and Traditional Chinese Medicine) was set up in the Faculty of Medicine of Florence, starting from 2011-2012.

An agreement (2008) between the Tuscany Region and Tuscan professional and medical associations has defined the training and accreditation for complementary medicine experts and schools. The agreement was signed by the regional federation of medical doctors and dentists, the regional committee of pharmacists and the regional federation of veterinary doctors. It provides for the establishment of lists of CM professionals who practice acupuncture, herbal medicine and homeopathy. Those wishing to register must have a certificate issued by accredited public and private training centres and must have completed a course of at least 450 training hours and 100 hours of clinical practice, after passing an examination and discussed a thesis. Courses for medical doctors and veterinaries cannot last less than 3 years. Training courses for pharmacists require at least 100 hours of theory and practice, and a course of no less than 1 year. Transitional provisions for professionals who started to practice complementary medicine before the law have been set up until April 2011.

Looking ahead: aims of the latest Regional Healthcare Plan (2008-11)
In July 2008 the Regional Council approved the Regional Health Plan 2008-11 based on principles of integration, freedom of therapeutic choice for users, freedom of treatment for doctors, quality, training, research, user safety, and networked organizational model for public activities of complementary medicine. The guidelines for the development aim to establish CM activities in all the health care centres, set up Integrated Complementary Medicine Centres in all the Local Health Units and strengthen the Tuscan networked organizational model.

The regional plan aims also to define the training and accreditation procedures for CM professionals and training schools, identify scientific literature and evaluate the application of CM in oncology in order to define diagnostic and therapeutic guidelines, and point out the contribution of CM in illnesses where there is clinical evidence of efficacy in international literature. It aims to provide high level professional training for doctors and medical staff and refresher courses for health workers, family doctors, paediatricians and veterinarians, including in the private sector, in collaboration with accredited regional schools. Also the development of health programmes to check and study adverse health reactions related to CM, to strength relations with the Regional Bioethics Committee, and dissemination of correct public information about complementary medicine are the objectives of the Plan.

Complementary medicine should be taken into consideration in family health clinics and centres to improve women’s health, to promote natural childbirth and breastfeeding, and treat menopausal disorders; in activities related to childhood, the elderly and patients with cancer, in mental health of adults and children, to fight pain and for terminally ill patients (in collaboration with regional palliative care services and hospices), to identify integrated procedures for treating widespread diseases like allergies, and finally to define intercultural models to address health problems of immigrants.

The regional plan finally suggests to carry out the research in collaboration with universities and private associations developing such issues as the effectiveness of therapies, gender health, social diseases and rehabilitation, users’ satisfaction, side effects, pharmaeconomy, and healthy lifestyles (Rossi et al. 2009).

The Tuscan Experience at an international level: CTM and international cooperation

The international activities and connections of the Tuscany Region in the field of complementary and traditional medicine are many. Among others, the international Seminar “Innovation and Development in the Health System: inclusion of complementary and traditional medicine in the Public Health System”, held in Florence in October 2008 and promoted by IDEASS, the program ART/UNDP Tuscany and Tuscany Region, ended with a Declaration evidencing a number of key factors on the subject of integration: the intercultural approach for health, respect of human rights, protection of natural resources[2], principles of complementarity, reciprocity, inclusion and respect for nature and the environment (Pellizzoli, Dario, 2008).

The Tuscany Region is committed in over 150 international projects for health care cooperation, implemented in morethan 30 countries of the global South. The principles inspiring the cooperation strategy of the Tuscany Region are that health is a fundamental human right and that its attainment is an important global social goal, whose realization requires the action of many social and economic sectors in addition to the healthcare sector. In particular, the main goals of the Regional Cooperation System consist in promoting sustainable human development within an integrated approach, at both the local and global levels, in order to strengthen civil society and create partnership networks.

The relevant experience of the Tuscany Region in promoting complementary and traditional medicine within its Regional Health System has had a clear impact on the kind of cooperation interventions promoted. In fact, many of the programs have supported the development of natural medicine and projects of decentralized cooperation have been carried out in Cuba, Senegal, Serbia and in Western Sahara, in collaboration with local and international institutions, associations and Non-Governmental Organizations (NGOs).

Natural and homeopathic medicine in Cuba
Activities of health cooperation of the Tuscany Region with Cuba, within the framework of natural and conventional medicine and in particular homeopathic medicine, started in 1994[1]. Many social and healthcare institutions have contributed to different cooperation projects, mainly carried out as decentralized cooperation. These activities have contributed to guaranteeing the sustainability of public health systems in Cuba and their results have been evaluated very positively by the partner institutions and the population alike.

The first cooperation project between the Pharmacy Faculty of Santiago of Cuba and the Homeopathic Association “Homeopathia Europea” was aimed at promoting homeopathy in Cuba as alternative treatment, in order to allow a rational use of primary health care resources, support homeopathic training of physicians, dentists, veterinarians and pharmacists, and create an homeopathic centre and laboratory for the production of homeopathic drugs for the population. This initiative was followed in 1998[3] by a project that supported the creation of a Natural and Homeopathic Medicine Centre at the “Hospital Clinico Quirurgico 10 de Octubre” in La Habana. A similar project brought to the renovation and improvement of the Centre for Traditional and Natural Medicine (CMTN) in the historical centre of La Habana. A further step was completed in 2002 when, with the support of the European Union, a laboratory for domestic production of homeopathic drugs was established at San Antonio de los Banos, a small village near La Habana.

Particularly innovative was the project in support of the Centre for Natural and Traditional Medicine (CNMT) of San Isidro (inaugurated in November 2003). Realized by the Municipality of La Habana Vieja and the Oficina del Historiador with the contribution of the Municipality of Viareggio and the Province of Lucca, the Centre aims at improving the health standards of the residents in the area through offering therapies that are sustainable both at the economic and environmental level and recovering sustainable traditional therapeutic methods. The Centre offers services of acupuncture, homeopathy, herbal medicine, aromatherapy, among others, and targets women and children in particular. The clinical activity is accompanied by training programmes for doctors and healthcare professionals. 102,845 visits (with an average of 70 patients a day) were made between the end of 2003 and the first semester of 2007.

Photo 1: Homeopathic pharmacy of the Traditional and Natural Medicine Clinic, Old Havana, Cuba.

Integration of complementary medicine in Serbia
In 2005 the Tuscany Region Healthcare Referral Centres for Complementary Medicine visited Serbia within the framework of the IDEASS programme and in cooperation with the “City to City” programme of the United Nations. The result of the visit was the project “Support to the Integration of Complementary Medicine into the Serbian Regional and National System”[4], approved by the Tuscan Region in July 2007 and promoted by the “Fior di Prugna” Centre in collaboration with the Regional Homeopathy Referral Centre in Lucca, the Institute of Social Medicine, the Faculty of Belgrade and the ART Tuscany Offices in Florence.

The main objective of the project is supporting the introduction of complementary practices into the National Health Service, based on the Tuscan model through the inclusion of complementary medicine in the public health system, financing a survey about the use of these therapies in the country and supporting their use in natural delivery, oncology, assistance to the elderly and palliative treatment.

Starting from 2010, the project was further developed with a stronger focus on mother and child health-care and, in particular, on promoting physiological delivery. A pilot project, to be implemented in Pancevo, will support the training of the health-care workers and promote a workshop on complementary medicine in support to physiological birth according to the Italian model. After six months, a questionnaire will be submitted to women in order to report their health status and that of newborns, and the results will be presented in a meeting aiming at exchanging the medical point of view and the complementary medicine’s perspective about natural birth for the benefit of population and families.

Photo 2: Training course at the University of Kragujevac, 2005.

Conclusions: towards an integration strategy

Complementary and traditional medicine can be a useful and sustainable resource in different fields of healthcare: chronic disease, style of life, physiological delivery, allergies, tumors, pre- and post-operation rehabilitation, epidemics, pediatrics, third age, dentistry, veterinary medicine. Their inclusion in public health systems must go hand in hand with an adequate process of scientific validation to control the efficacy, safety and quality of health services and products by means of case/control observational studies, as well as randomized and double-blind clinical trials for the treatment of pathologies of particular social interest. Major initiatives and actions aimed at achieving strategies of inclusion of complementary and traditional medicine in the public health care systems also include the introduction of these therapies in regional and national health care planning, in programmes of public health structures, and the approval of regional and/or national laws. Programmes for training public health care workers also deserve special attention, as well as University graduate and post-graduate vocational training and constant professional refresher courses. Finally, information to citizens is of primary importance for the development and success of integration process.

The experience of the Tuscany Region in this field, both within its territory and in countries of the South that are supported through initiatives of international cooperation, can be considered extremely relevant when compared to other Regions in Italy and in Europe. Future project is to maintain these innovative experiences and root them more and more in Tuscany territory in close relationship with the regional health policy.

References

Pellizzoli R., G. Dario (2008), ‘“Innovation and development in health: integration of complementary and traditional medicine in public health systems”, 28-31 October 2008, Florence’, Universitas Forum: International Journal on Human Development and International Cooperation, 1(1), in: http://www.universitasforum.org/index.php/ojs/article/view/11
Rossi E., S. Baccetti, F. Firenzuoli, K. Belvedere (2008) ‘Homeopathy and complementary medicine in Tuscany, Italy: integration in the public health system’, Homeopathy 97(70-75).
Rossi E, C. Endrizzi, M.A. Panozzo, A. Bianchi, M. Da Frè (2009), ‘Homeopathic therapy in the public health service: an observational study conducted from 1998 to 2005 at the Campo di Marte Hospital-ASL 2 Lucca (Italy)’, Homeopathy 98(143-8).
Smallwood C. (2009) ‘The Role of Complementary and Alternative Medicine in the NHS. An investigation into the potential contribution of mainstream complemenatry therapies to healthcare in the UK’, in: http://www.getwelluk.com/uploadedFiles/Publications/SmallwoodReport.pdf