Regulation i_need_contribute
2020-05-12 [Regulation]
By Dr. Ramón Mª Calduch I Farnós


To begin with, there is nothing better than data which show the remarkable reception, and especially the excellent satisfaction that the treatments based on natural therapies generate on Spanish citizens:


  • According to a report prepared by the General Council of Physiotherapist Associations of Spain, in the pilot program developed at the Hospital de Mataró (Barcelona) in 2007, with a treated population of 268 patients, 33% presented an improvement in functional capacity and 11% an improvement in psychological well-being... Patients showed excellent satisfaction with the care received [...].
  • In relation to the knowledge, usage and natural medicine satisfaction and among the natural medicines there is specifically Chinese Medicine, it is also necessary to refer to the "Situation Analysis of Natural Therapies", prepared by the Working Group on Natural Therapies, which in May 2008 published a research in which it is highlighted that 95.4% of the Spanish population knows about some natural therapy, the most popular are yoga, acupuncture/Traditional Chinese Medicine, Tai Chi, chiromassage and homeopathy, all of them mentioned by more than 50% of the population:
  • 23.6% of the population has used natural therapies on some occasion, mainly yoga, acupuncture and chiromassage, although there are geographical differences. In this same order of things, the same report highlights that the usage frequency of each of the fields of natural therapies by the total population who undergoes natural therapies treatments is as follows:
















  • In the same context, but in this case arising from the research (2009) prepared by the Catalan's Government Department of Health, regarding the Spanish case, it is remarkable that the information provided by this research is interesting as well, in this case estimating that a 67% of chronic patients use some kind of natural therapy.
  • In this regard, the results offered by a research developed by TENACAT are also very noteworthy. The research, focused on the usage and satisfaction of natural therapies in Spain, provided the following data:
  1. The level of satisfaction achieved (with the occasional usage of natural therapies) by the interviewees, reaches the 60% among them. A 60% who is "very or fairly satisfied" on the question raised.
  1. Higher percentage of female users than male users.
  1. Dominance of users belonging to the upper-middle/high class.
  1. Age mostly between 36 and 45 years old.
  1. Users who are mostly residents of urban metropolitan areas.


  • On 8th March 2018, the Centre for Sociological Research (CIS in Spanish) of Spain, published a barometer which included a detailed analysis on the usage of alternative therapies to conventional medicine such as acupuncture, Traditional Chinese Medicine or homeopathy:
  1. a)The best known of all of them is yoga with 90.3% of respondents who say they know this kind of therapy.
  2. b)The research also emphasizes: acupuncture (89,1),
  3. c)Traditional Chinese Medicine (54,9),
  4. d)homeopathy (66,5),
  5. e)meditation (74,9),
  6. f)therapeutic massage (74,2)
  7. g)hypnotherapy (66,5).


The CIS barometer highlights that the majority of respondents who knew about complementary medicine and actually know what they are, have used these therapeutic techniques to help them to have a healthy and balanced life (47.8%), and to cure diseases and ailments for which conventional medicine is not effective for them (31.8%).


As can be seen, from 2008 to 2018, the knowledge and usage of NTs not only have not decreased, but they have remained at high levels and have even increased.



In Spain, in contrast with our neighbouring country, Portugal, there is no regulation of Natural Therapies and, therefore, neither of Acupuncture and TCM.

In Spain, in fact, after the report issued on natural therapies by the Health Commission of the Spanish Parliament, on 19th December 2011, we have not observed substantial movements of regulatory interest by the Government despite the insistence of professional associations.

In the last two years, we are attending a kind of campaign against natural therapies in the sense of highlighting their lack of scientific evidence, including all of them under the same umbrella. Its dangerousness is highlighted, either by toxicity, malpractice or by irremediably replacing conventional medicine, with negative results and its persecution is proposed. Even a political party has just presented a legal proposal in that sense.

From a paused analysis of this recent Legal Proposition, we can draw two important conclusions:

  1. A) What is stated in this analysis is "to conduct appropriate legal changes in order that health professionals are obliged to communicate to the relevant legal authorities (prosecutor's office or duty court) the practices performed by professionals, graduates or not graduates, that far from the scientific evidence could cause a real damage to the direct health of their patients".

For these practices to be reportable, two requirements shall be fulfilled: (1) lack scientific evidence and (2) cause real harm to the health of patients.

Clearly, the lack of regulation of Natural Therapies in Spain allows good professionals and charlatans to be under the same umbrella, harming the former and the citizenship in general. We also know that there is a sector of "pseudoscientists" who are dedicated to the denial of scientific evidence of everything that sounds like Natural Therapies, proposing the prohibition of everything that is different from the "official allopathic medicine", western, ignoring the recommendations of the WHO regarding Traditional Medicines, and the reality of them, also at the level of scientific evidence.

  1. B) As mentioned earlier, the lack of regulation of Natural Therapies is the basis of the problem. In fact, in the countries where they are regulated, there is a control over them, which minimizes to the maximum the possibility of what is intended to be avoided with this Proposal Not of Law.
  3. We find it surprising this Legal Proposition is promoted and that, at the same time, regulation is not promoted, which is indicated as necessary in its text.
    1. We agree that fraud and chicanery must be pursued. What we do not agree on is that, with this excuse, the persecution of good professionals in Natural Therapies is encouraged, keeping without regulation a sector that brings unquestionable benefits to the health of citizens.

In the case of Spain, the acceptance and penetration of Alternative and Complementary Medicines, and of course Acupuncture and Chinese Medicine, it is far from having been coordinated with the level of legislation, regulation and explicit legal recognition by the competent authorities.


Thus far, there is no regulation in Spain regarding Acupuncture/TCM, beyond what is regulated by Decree 1277/2003, for health professionals, the epigraph for tax registration and the labour agreement of the sector for non-health professionals (paramedical services) who practice them. There is also no specific regulation on the training or certification of people who practice Acupuncture and Chinese Medicine. In fact, health professionals and non-health professionals who practice them coexist.


For health professionals, Decree 1277/2003 establishes, in its classification of health centres, the U101 unit of health care (non-conventional therapies), which requires that the director of the centre to be a Western Medicine doctor. As a result, health professionals who are not doctors must practice Acupuncture/TCM as paramedics or be under the direction of a Western Medicine doctor. Although this last issue is being questioned lately, creates serious problems to projects like the City council of Beijing in Barcelona where Chinese doctors are not being able to exert, not even under the orders of a Western Medicine doctor.


For those who are not health professionals, the health authorities of the autonomous communities (which are those with the power of inspection) are aware that there are centres which do not register as sanitary facilities, legally established, due to "the lack of regulatory norms which regulate this specific healthcare".


The non-medical professionals of Chinese Medicine are registered in the corresponding Social Security scheme and obtain the registration of economic activity, as well as the municipal license as paramedical professionals related to paramedical activities (naturopaths, acupuncturists and other paramedical professionals), under the Royal Decree 1175/1990, of 28th September, which approves the rates and instructions of the tax on economic activities, which includes in its annexe 1 the aforementioned economic activity in group 944: services of naturopathy, acupuncture and other paramedic services, and as a professional activity in group 84: professionals related to paramedical activities, of the Group 841: naturopaths, acupuncturists and other paramedical professionals.


Likewise, it is established (in several sentences of the Supreme Court and of several Provincial Courts) that the practice of Acupuncture/TCM cannot accept the crime of intrusion, when it is performed by non-health professionals, due to the lack of evidence that it is about "own acts".


Although some insurance companies include them in their coverage, Acupuncture and Chinese Medicine are not financed by the public health system. However, in the case of Acupuncture, there are several acupuncture units in hospitals and primary healthcare centres. As an example, in 2005 there were 12 units in Andalusia, in which Acupuncture was applied regularly; half of them are located in the hospital environment and the other half in health centres.


In Spain there is a high number (much higher than health centres), although it has not been quantified, of Acupuncture centres and Chinese Medicine, without sanitary authorization, where non-health professionals are exerting. They register as non-health centres, avoiding advertising with medical terminology, so as not to be sanctioned or closed.


However, when the sanitary inspection of the autonomous communities intervenes (due to having transferred the competences), their interpretation is that they are health activities and, therefore, must fulfil the requirements of health centres.


The existing confusion comes from an interpretation, from our erroneous point of view, of Decree 1277/2003, which in no case stipulates that the acupuncturist activity must be exerted exclusively by a doctor, but refers to the classification of the non-conventional medicines for health centres (U101), which require a Western Medicine medical director. They extrapolate it, erroneously, for any type of centre, including non-sanitary centres.

Non-medical acupuncturists, considered paramedical (non-medical activity), pay their taxes, and they have been registered to the tax register in epigraph 841 of Economic Activities, "Acupuncturist, naturopath and other paramedical services". In addition, they have recently been subject to the agreement of the sector, which, as can be understood from its reading, includes acupuncture and makes explicit that we are in a sector pending of regulation.

The training in Acupuncture is not included in the curriculum of any health university degree, although they are university-specific degrees courses in other countries in Europe and the world (Canada, PR China, United States, Great Britain, Portugal, Germany, etc.)



That said, we see that there is a clear legal vacuum and, as a result, a high risk that the authorities recognize as Health Centres the Natural Therapies Centres, forcing them all to have the presence of a Bachelor of Medicine and Surgery.


It seems that from the sentences of the Supreme Court clearly derive the consideration of acupuncture as a healthcare activity that would be integrated in the section corresponding to the Health Unit 101, being applicable the Royal Decree 1277/2.003, of 10th October, basic norm and regulation of the Law 44/2003, of 21stNovember, of the Regulation of Health Professions.


That said, we also find that, from the Sentence of the National Court of 23 September 2009, although dictated in the context of education, it is possible to find a framework for the continuity of the activity. Thus, in this educational context, but in the legal basis of the aforementioned Sentence we can draw conclusions, that the profession is not regulated and that the activity performed by professionals who practice it does not require certification, nor is it included in the National Healthcare System, thus the activity must not cease because although it lacks regulation, it has fiscal and labour recognition (collective agreement of the sector).


The legal vacuum, where the uncertainty is evident, affects the reality of Spain and other countries where regulation is lacking and the scenario turns out to be that there are more non-health professionals with open centres than health professionals with sanitary authorization.


Nor can we say that there is a real "witch-hunt" in Spain since the health inspection intervention in this area usually occurs only at the request of a competitor, collective, patient, among others.


It is noteworthy that there are no criminal complaints for intrusion against non-health professionals for merely exerting of their activity. This is because if the professional can accredit the necessary knowledge (via certification and academic program) for the activity performed, the Sentence will be favourable inasmuch as the studies are not regulated there is no reserve for any health profession.


In terms of Chinese Medicine and Acupuncture studies, the Spanish Ministry of Education and Science considers studies of Chinese Medicine and Acupuncture as non-regulated education and, as such, do not have official recognition.


The education of Acupuncture/Chinese Medicine is provided in many different institutions: universities, private schools, professional associations, associations, among others both undergraduate and postgraduate or master, are addressed both to health professionals and non-health professionals.


In conclusion, on the one hand, there are health professionals who may have received education in Acupuncture in Spain in:


  • . Several Spanish public and private universities which offer acupuncture training courses for doctors and/or other health professionals.
  • . Other schools and organizations, such as associations of doctors or physiotherapists.


And on the other hand, there are non-health professionals who have acquired their knowledge through private schools, as non-regulated education, or in universities, obtaining a master's or postgraduate degree, if they have a university degree in any area, or of a certificate of achievement in Acupuncture/Chinese medicine, on the contrary.


What is exposed is nothing more than the evidence that we are facing a lack of legal regulation of a recognized activity, from the Fiscal point of view, as an economic activity. It is also recognized in terms of work by the Collective Agreement of the sector.


Spanish regulations perfectly regulate both health activity and health professionals. However, this does not prevent the existence of other types of professional actions, which even belonging to the field of health have not yet been regulated as sanitary, and this notwithstanding that such unregulated activities can be performed by health professionals and, in that case, if its regulation exists, from the perspective that a doctor (sanitary) can use all those arts with scientific evidence at his disposal, for the treatment of his patients, provided that he has the necessary knowledge and under his responsibility.


In view of the above, it is clear that even though nothing prevents these therapies from being considered sanitary in the future, since the regulations so stipulate, at the present, there are no regulations in this regard. It is totally inadmissible that the absence of legal-positive regulations applicable to a specific case, lead to the application of regulations in an arbitrary manner, without any basis or criterion.


It is noteworthy that the Commission on Health and Consumers of the Congress of Deputies of 11st December 2007 approved a Non Law Proposal in which urged the government to create a working group between the Ministry of Health and Consumes and the Autonomous Communities to promote a joint consideration which concludes with a report for the purposes of a future regulation of Natural Therapies in our country. Even so, to date, the aforementioned regulation has not been raised.


The Spanish case is the case of a country which only allows in its National Healthcare System, and in the educational system (in its sanitary branch), the specialties, techniques and procedures which correspond to Western Conventional Medicine and it is hermetic and closed to the possibility of giving access to its health education system and its medical system to another kind of professionals who are not the ones officially established and who all correspond to allopathic medicine.


The Spanish case is also that case of a country that, as we have seen in a generic way before, in recent years has given entry to specific education in Chinese Medicine and its techniques, in addition to giving entry to the so-called alternative medicines. However, this entry has not been made by creating an entry and an independent route but has been created as an appendix for licentiates (graduates) in allopathic health certifications. It must be said that for example, a whole set of master's degrees (postgraduate studies) has been created for graduates in medicine, physiotherapy... This amounts to saying that what the Spanish educational system pursues, unfortunately, is not to accommodate Chinese Medicine professionals so that they can perform, officially and regulated, their professional specialities, but what is intended is to specialize their own health professionals to take their place.


Unfortunately, some projects supported from China, such as the Hospitalet de Llobregat (Barcelona), abound in this criterion, wrong in my opinion and that will hinder the future development of Chinese Medicine in Spain.


Even so, the existence of these masters, and of these certifications, is already an advance in itself, since it means recognizing the validity and properties of alternative medical systems such as Chinese Medicine and its techniques.



Last but not least, we will refer to the phytotherapy of Chinese Medicine.


Usage of medicinal plants is regulated, in Spain, by Law 29/2006, of 26th July, on guarantees and rational use of medicines and health products (modified by Law 28/2009, of 30 December), and by Royal Decree 1345/2007 of 11st   October, which regulates the authorization procedure, registration and dispensation of industrially manufactured medicines for human use.


Article 51 provides that the Ministry of Health shall establish a list of plants whose sale to the public shall be restricted or prohibited due to its toxicity and that there are plants which can be sold freely to the public, since they are traditionally considered as medicinal plants, provided they are offered without referring to therapeutic, diagnostic or preventive properties and, in addition, its itinerant trade is prohibited.


Royal Decree 1345/2007, in its fourth section, is dedicated to traditional medicinal herbal products.


On the one hand, this Royal Decree establishes the obligation to register traditional medicines based on plants, the criteria that shall be fulfilled to register through the simplified procedure, the reasons for refusal of registration and the withdrawal from the market when a plant substance, preparations or combinations of plants is no longer included in the list drawn up by the European Medicines Agency's Committee on Herbal Medicinal Products.


In addition, the order SCO/190/2004 of 28th January elaborates a list of plants whose sale to the public is prohibited or restricted due to its toxicity.


In Spain, the commercialization of Chinese herbal products has the consideration of a medication, while it is freely sold as a food supplement in many other countries of the European Union.


Given the disparity of regulations on plant-based products in the different countries of the EU, in April 2004 was published the Community Directive 24/2004/EC, on "traditional herbal medicines", which allowed the way of a simplified registry, if certain conditions are fulfilled, and which came into force in April 2011.


This Community Directive (and its transposition to national regulations in each country) introduces the concept of mutual recognition, which benefits Spanish consumers, since when these products are registered in any EU country, Spain cannot oppose registration, unless it demonstrates, scientifically, that it has a certain degree of danger.


At present, given the situation in Spain, my recommendation is to register the products as food supplements in some of the most permissive countries of the EU and then use the mutual recognition procedure, to be able to legally introduce them into the Spanish market.


Personally, I think we should look for an autonomous solution for Chinese phytotherapy at European level, given its own characteristics. One of the possible solutions would be a collaboration agreement between the European authorities and the Chinese authorities, to evaluate and recognize in Europe the particularities of Chinese Medicine and, among them, recognize that it is based on a personalized prescription which, in addition, varies throughout the treatment. Meanwhile, in order to avoid the lack of products for patients, the path of food supplements and monographs for its registration as traditional herbal medicines could be a transitory solution which allows them to be placed on the market, through mutual recognition, in those less permissive countries, such as Spain.


Mention, lastly, that Chinese herbal medicine is currently accessible in Spain, marketed by two laboratories that have registered the products as food supplements in Belgium and that have notified them in Spain (for food products only marketing communication is needed) through mutual recognition. In addition to the online purchase that can be performed directly by patients (because they cannot be marketed in Spain) in other EU countries, in the interest of free movement of products.


At the moment, there are only two Chinese phytotherapy products registered as a herbal medicine in the EU, while the rest of the products that have been legally introduced in the market as food supplements.



Regarding the possible siting of the studies of Chinese Medicine and their respective techniques (such as Acupuncture) in the Spanish Educational System, I would like to state again what has already been said and exposed: the only appropriate placement of these studies is the one that allows to train and develop specific graduates to the subjects taught, without having to have a direct relationship with conventional health professionals. In other words, students of Chinese Medicine and Acupuncture should study and directly become practitioners of this kind of medicine and be officially recognized as health professionals, without previously having to be certified as doctors or Western Medicine graduates.

That said, I would like to mention that the two existing paths in the health sciences in the Spanish educational system are already optimal and suitable for these studies, in other words, it is not necessary to change the system or the existing mechanisms, it simply needs to be framed within the university studies and within the studies of Vocational Training of the branch of the Health Sciences, these disciplines should be considered as disciplines of full right, and not as appendices or complements of the existing ones of an allopathic nature.

The next step that the educational system has to take is to dissociate the concept of Acupuncture (and Chinese Medicine) inevitably from a task exclusively for allopathic graduates, dissociate corporatist interests and start the development of excellent trainers and trained in this discipline.




Chinese Medicine is based on holistic patterns, non-causal relationships, non-linear logic and non-reductionist phenomenology, unlike Western Medicine based on linear causality and often, when certain phenomena do not fit the current Western scientific theories, are discarded without further ado.


Acupuncture/TCM has reached the West to stay. In fact, the WHO strongly recommends the regulation of Traditional and Complementary Medicines and their integration into the National Health Systems in the WHO Traditional Medicine Strategy: 2014-2023, in response to the needs and challenges identified by the Member States.


In Spain, in the working document "Analysis of the Situation of Natural Therapies" prepared by the group of Natural Therapies of the Ministry of Health and Social Policy, it is repeatedly stated that the heterogeneity of Natural Therapies makes it difficult to delimit its scope, but without entering at no time to assess in what type of centres impart education in this regard, the type of studies, training programs, duration of studies, among others. If it had been assessed it would have been shown that some of the Natural Therapies such as Traditional Chinese Medicine (in which Acupuncture is included) are university studies in their country of origin with a duration of 5 academic courses for obtaining the degree which makes possible its professional exercise. It would also have been shown that these studies are considered sanitary in their countries of origin.


The individualized analysis of each of the Natural Therapies with an appropriate level of depth would give a more accurate response to the considerations to be taken into account in the light of a possible regulation.


The research performed allows us to conclude that they must be included within the family of Health Sciences.


Regarding how the regulation as we understand should be, in light of the present investigation, necessary and convenient, we have been able to confirm that the current trend is to go towards a model similar to the one existing in Portugal or Australia, which have been the last to regulate, but with the addition that the training and professional certification of doctors and other health collectives must also be regulated.


It is obvious that the main thing is the safety, quality and effectiveness of the treatments of the professionals who practice Acupuncture/Chinese Medicine. As well as this scientific discipline can make further progress, as any science and also can move forward in its integration with Western Medicine and its future inclusion in the National Health Systems.


For all these reasons, in Spain and also for the rest of the countries of the EU, in terms of Acupuncture/TCM, we understand that higher studies and/or university studies of 240 ECTS should be established, with their subsequent postgraduate studies, masters and doctorates, which could be accessed with the same requirements as for accessing any university degree in Health Sciences.


Moreover, for Western doctors and other health professionals, we propose postgraduate and/or masters of 120 ECTS (with less dedication it is not possible to assume the minimum knowledge required), adapted to their professional profile, which opens the way to professional practice and possible doctorates. It would not be logical that any Western doctor, for the simple fact of being one, with a short Acupuncture/Chinese Medicine course could exert such discipline. Nor that the doctors did not have a regulation that allowed them to apply the knowledge of the two kinds of medicine in a single integrative medicine in their corresponding specialities.