Verbatim report of proceedings

Tuesday, 16 December 2003 - Strasbourg

7. Traditional herbal medicinal products

  President. – The next item is the recommendation for second reading (Α5-0452/2003), on behalf of the Committee on the Environment, Public Health and Consumer Policy, on traditional herbal medicinal products (12754/1/2003 C5-0519/2003 2002/0008(COD)) (Rapporteur: Mr Nistico).

  Nisticò (PPE-DE), rapporteur. – (IT) Mr President, after this report on the legislative package regarding medicinal products – a report that, as we have seen, made veins and pulses tremor – my report is like drinking a relaxing cup of camomile tea. I am in fact extremely satisfied, and I would, therefore, like to thank both the Council and the Commission, and also all the shadow rapporteurs, in particular Mrs Roth-Behrendt who I am sorry to say is not here today because she has the flu – and she apologises for her absence – and of course all the Members who contributed to improving this directive.

The directive, as adopted, finally brings order to an area that is very confused and much debated. On the one hand, it precisely states the scope of the directive and excludes the use of herbal products as provided for in the other directives; on the other hand, in the interests of consumers and their health protection, it specifies characteristics regarding quality and good production practice. Whilst the value of therapy with traditional herbal products must be recognised, it must also not be forgotten that inappropriate use can lead to the emergence of undesired side effects, sometimes serious ones. So far, for example, the ‘Food and Drug Administration’ has registered about 2 900 cases of toxic effects, including, if you look closely, 104 deaths predominantly caused by abuse of ephedra, as well as serious side effects of other products that are used daily such as St John’s Wort, ginkgo biloba and also ginseng.

This is why it was important to adopt a directive that seeks to protect consumer health which, on the one hand, calls for better quality and safety standards, but also, on the other hand, for it to be obligatory for labels and illustrative leaflets to include rigorous scientific indications that are simple and clear for citizens about the potential toxicity of herbal medicines, as well as their interaction with food, drinks and other medicinal products when taken together.

As you know traditional herbal medicines mean those that have been in use for at least 30 years, of which 15 years in countries of the Community. Nevertheless, at the request of an individual country – and this was a reason for improving the directive – and with a reasoned opinion from the Technical and Scientific Committee for Herbal Medicinal Products of the European Agency for the Evaluation of Medicinal Products (EMEA), the period of use of 15 years can be significantly reduced.

Another positive aspect is the creation of a Committee for Herbal Medicinal Products as part of the EMEA. Parliament clearly indicated how this committee should be distinct from the Committee on Proprietary Medicinal Products. It should deal with classification, with preparing a list of traditional medicinal herbs, with updating lists, with preparing relevant monographs, and with assessing dossiers in the event of disputes at national level. At second reading, Parliament proposed and also adopted two amendments. In particular, an initial amendment inserted in the recital intends to clarify, somewhat unnecessarily, the scope of the present directive by specifying that this only regards traditional herbal medicinal products, whilst the use of plants or herbs for food use fall under the current specific European legislation for food products. The second amendment is merely a specification: it concerns inserting the word ‘traditional’ when talking about herbal products. Both of the amendments were then adopted by the Council, as appears from the communication to the Committee on the Environment, Public Health and Consumer Policy of 8 December 2003.

After all, the current directive defines the harmonised legislative framework for all countries of the European Union in favour of free movement of traditional herbal medicinal products within the Community. This guarantees, furthermore, the maximum level of public health protection on the basis of documentation requested regarding quality, efficacy and safety.

  Liikanen, Commission. In January 2002 the Commission proposed its directive amending, as regards traditional herbal products, the Community code relating to medicinal products for human use. Now we have the possibility to adopt the legislation successfully in the second reading. I would like to thank the rapporteur, Mr. Nisticò, for his consistent effort in this.

What were the concerns that we wanted to address through the adoption of this legislative initiative? The proposal aimed at guaranteeing a high level of health protection for European patients using traditional herbal products. It was also intended to ensure a single market for herbal medicines by introducing harmonised rules and procedures. To that end, the proposal provided for a simplified registration system for traditional herbal products. The quality requirements to be met are the same as those for all medicinal products. But to avoid unnecessary testing and burdens on firms, the legislation foresees that new pre-clinical and clinical trials will not be necessary when sufficient knowledge already exists about a particular product.

The Council common position is consistent with these objectives and main principles. Moreover, it retains the substance of around two-thirds of the amendments proposed by the EP during its first reading.

On 27 November the parliamentary committee adopted two amendments. The Council has already acknowledged that it finds these amendments acceptable. The first aims at clarifying that foodstuffs (including herbal products) will continue to fall within the scope of food law. The second aims at specifying the purpose of the list of herbal substances to be drawn up by the future committee on herbal medicinal products. The Commission supports these two clarifications.

I would like to take this opportunity to thank you all for your efforts concerning the adoption of this directive, and in particular for the discussions over the past weeks leading to the possibility of successfully concluding the dossier during this second reading at the European Parliament.

  Doyle (PPE-DE). – Mr President, I should like to commend Mr Nisticò on his success in bringing Parliament and the Council together on the issues that remained outstanding during the second reading.

As a result of negotiations between all concerned, a compromise was agreed on prior to the vote in the Committee on the Environment, Public Health and Consumer Policy, allowing for a consensus incorporating only two amendments tabled by myself and other colleagues from an original list of ten amendments.

Under the first of these amendments, traditional herbal food products that are non-medicinal should continue to come under existing food legislation and not pharmaceuticals legislation.

The second amendment essentially provides that the list of herbal substances to be set up by the Committee for Herbal Medicinal Products should only cover the medicinal use of herbal substances. This would allow, for example, herbs to be used, along with vitamins and minerals, as food supplements and to come under food legislation. This logical approach avoids overlapping jurisdictions.

The solution presented in the common position and the European Parliament's two amendments is eminently sensible and has the full support of the Commission. I would urge colleagues to give them a positive vote tomorrow.

I welcome this directive, which recognises the value of medicinal plants as an important complement to modern chemical medicines. The traditional and herbal medicines sector is one that is of increasing significance and is expanding in scope and popularity across the Community. This directive allows for the fast-tracking of traditional medicinal herbs, which is most welcome.

However, we must look towards establishing systems that encourage research and development. This was a key concern of mine in my former Amendment No 10, tabled in the Environment Committee, which was aimed, at one level, at avoiding the constraints imposed by an overly narrow and historical definition of traditional medicines, to further product development. This amendment was withdrawn in the interest - shared by all of us here - of maintaining the integrity of the directive.

As in the conventional medicines field, innovation must be encouraged in this area and we must look to the future as well as to the past. I hope that when the Commission reviews this directive in three years' time it will recognise that this is a dynamic field and one in which new products are constantly emerging. While efficacy and safety must never be compromised, we need to look at building in mechanisms that will allow traditional medicines to continue to evolve in terms of their application and use and the better exploitation of the therapeutic potential of medicinal plants.

This is an exciting area, one that we must not be afraid of, and one that will not benefit from over-regulation. We must protect the consumer in terms of efficacy and safety, but at the end of the day we must leave the choice with the consumer.

Again, I thank Mr Nisticò for his sympathetic acceptance of colleagues' views and of our amendments in the various areas. I thank him for his cooperation throughout.

  Stihler (PSE). – Mr President, I thank our rapporteur, Professor Nisticò, who has done a lot of work considering how controversial this debate was in first reading.

The directive based on the common position text will introduce a regulatory regime for traditional herbal medicines, giving the public assurances as to safety and quality, as well as systematic consumer information relating to traditional herbal remedies sold over the counter. The common position incorporates significant additional areas of flexibility over the scope of the directive, as had been sought by Labour MEPs, including a number of herbal interest groups as well.

These include greater flexibility to take account of evidence of traditional use from outside the EU and the possibility of vitamins and minerals being added to traditional herbal remedies which are ancillary to the activity or the active herbal ingredients. It is due to this progress that we have had very few people disagreeing with our approach during this second reading. As I described in first reading, presently consumers are unaware of some shoddy practices going on in this sector. Last year I gave the example of echinacea root. Over the past few weeks there has been some debate over echinacea due to a report by the University of Washington in Seattle questioning its effectiveness. However, there are plenty of other reports highlighting its effectiveness and, as a user of this product, I believe it helps especially at this time of year in combating colds.

Sadly, in information provided to me analysing four different echinacea root products only one contained what it claimed it had on the label. This is not good for echinacea and certainly not good for the consumer. One product failed to comply because of excessive amounts of ash and acids in soluble ash. Another did not contain echinacea root at all and another had not been solely manufactured from echinacea root powder, as was claimed on the label. This means that when I purchase this product I have a one in four chance of getting what is described on the label. This is just not good enough. That is why the Consumers' Association, the British Herbal Medical Association, the European Herbal Practitioners' Association, the UK National Institute of Medical Herbalists, the Register of Chinese Herbal Medicine, the International Register of Consultant Herbalists and similar herbal practitioners across Europe back this initiative.

The message from genuine manufacturers who love the herbal sector is clear: they need basic regulations which reward quality producers and give consumers the standards they deserve. The herbal sector is no longer a cottage industry. It is a multi-million-dollar industry, and genuine manufacturers who are doing the right thing are suffering commercially because cowboy dealers are breaking the rules. We need regulation in this sector in order to protect the consumer and reward those decent producers making quality products.

I hope Members will back this recommendation for second reading and the sooner this becomes law, the better. I should like to thank Professor Nisticò once again.

  McKenna (Verts/ALE). – Mr President, this directive is supposed to harmonise the legislative framework for traditional herbal medicines. While I believe it is very important that we try to cut out cowboys and people who operate in a completely unacceptable manner, this legislation was supposed to provide a simplified registration procedure that would allow the registration and marketing of certain traditional herbal medicines that have been on the market for a specific period of time.

In the first reading it was quite clearly limited to herbal medicinal products or pharmacological activity and excluded food supplements. Many feel that it is extremely important to protect the herbal supplements already on the markets of most Member States. These herbal supplements should be regulated under food law.

We need to safeguard the long-term future of traditional medicines, which I believe are much more important and beneficial than the synthetic and pharmaceutical approaches to health care.

Member States must also be allowed to introduce national rules on their territory to accommodate any traditional or non-conventional approaches to health care not covered by the directive. Health care must take precedence over commercial considerations. Where Member States wish to have control over any health care tradition that they consider to be of value to their citizens, they should be entitled to do so, regardless of the aspirations for commercial harmonisation.

Harmonisation should not mean that diversity is destroyed. European citizens have a right to retain their local cultural traditions. This is particularly important where the cultural traditions relate to health care products that are not yet scientifically understood. Traditional medicines should be protected as living traditions. In many EU countries traditional medicine is a living tradition that has continued to evolve over many years and has the capacity to continue to evolve.

The natural evolution of traditional medicine is stunted by this directive that defines 'traditional' in a purely historical context and restricts its application to what took place many years ago. The scope of traditional medicine is greater than the directive recognises. This must be taken into account. Traditional medicines are used extensively to treat a wide range of serious conditions in Member States, which should be entitled to introduce appropriate regulation to accommodate such practices. I believe that if you stunt the possibility for traditional medicines, you are doing a disservice to the consumer and the public. Everyone recognises that there are people who act in an unorthodox manner, but I believe that traditional medicine is much more beneficial, in the long term, than the pharmaceutical approach.

  Andersen (EDD). – (DA) Mr President, many people have good experiences of using herbal medicine to supplement ordinary medicine and treatment. Herbal medicine must, moreover, be seen as an ecologically sound alternative to the many unnatural chemicals we let out into the environment in the form of chemical medicine.

The area of natural medicine is far from being fully charted. There are presumably many good products around the world that we have still not used or with which we are unfamiliar in Europe. We must not rule out the development of all these known and unknown ecologically sound medicinal preparations. That is what I in actual fact think we are doing with the directive’s demand for approval and registration.

In Denmark, we obtained a similar regulation of herbal preparations a few years ago. From previously having approximately 2 500 different products, there are now only 50 approved products. Well-educated and experienced therapists now complain about the lack of legal access to many important preparations for treating, for example, cancer and allergies. I cannot therefore support the directive.

  Booth (EDD). – Mr President, I appreciate that a large number of people will benefit enormously from this directive - the lobbyists and those who are entertained by them. But vast numbers of UK suppliers of herbal medicines are small business people, often sole traders, for whom the prospect of having to register products under this directive will be a burden too great to contemplate. The result will inevitably be the decline of the small specialist shopkeeper in favour of the large pharmaceutical companies.

With this proposed directive we are seeing yet another imposition of the Nanny State, creating laws where none currently exist in the UK, for a well-established small market whose consumers are invariably well informed. The proposed amendments will disallow the registration of significant numbers of products currently recognised as traditional herbal medicines, on which many people depend for their wellbeing and in which they have great faith. My party is totally opposed to this legislation, which we see as yet another area in which harmonisation is being imposed to the detriment of the freedom of individuals.

  Ahern (Verts/ALE). – Mr President, I understand that the purpose of this proposal is to allow the regulation of herbal medicines under a simplified procedure. However, it is a fact that producers, retailers and consumers have been astonished and dismayed by the cascade of highly restrictive legislation dealing with such products that have been safe and available in certain Member States including my own for many years. We have heard from certain colleagues, particularly in the UK, that is also the case there.

We need simple, basic regulation to protect the consumer because there are, as Mrs Stihler has said, products that purport to contain herbal remedies that do not actually contain those herbals. However, while doing that, we need to ensure that products are not withdrawn from the market as a result of legislation and we cannot be certain that this is going to be the case under the present procedures.

I welcome the clarification that the amendments make to the report. It is particularly important to clarify that the Committee for Herbal Medicines should only deal with products for medicinal use, not food use. I, like MrsStihler, use echinacea. I also use garlic. Garlic is an extremely potent medicinal remedy; it is also a food in wide circulation. We risk making a nonsense of ourselves if we allow this committee to deal with food products. I want to emphasise this point to the Commissioner and I hope he takes it on board.

I would like to thank all the colleagues in the Committee on the Environment, Public Health and Consumer Policy for their hard work, but it is a fact that there is a great diversity of traditions within the Community and the harmonisation of this legislation really risks losing products that are in safe use and have been in safe use for many years. Our citizens will not accept this. I give the Commissioner full warning that if this ensues it will not be a happy result either for the Member States or for Brussels.

  President. – Thank you, Commissioner.

The debate is closed.

The vote will take place tomorrow at 12 noon.