14 Legal Aspects of Leech Therapy in the EU and USA For the German first edition of the present book, which was published by HAUG Verlag, it was only necessary to present the legal aspects of leech therapy subject to German jurisdiction. The present English-language edition of the book, however, is an internationally oriented version. As such, it must provide an expanded view of the legal issues pertaining to leeching in order to guarantee a successful implementation of leech therapy in the USA and other countries. We feel that it is appropriate to compare and discuss the currently different legal classifications of the medicinal leech as a “medical device” in the USA and as a “drug/medicinal product” in the European Union (EU). The standards of both systems of drug law have undergone considerable change in the last decades. This requires a short introduction to the drug law systems of the USA and EU (see below). The medical systems of the USA and EU are structured differently, as are those of different countries within the EU. Therefore, specific rules may apply only to certain countries. Those pertaining only to Germany, for example, are marked “German law.” In order not to expand the scope of the legal aspects of leech therapy disproportionately, the authors ask the readers to independently research the national regulations for the described legal areas to ensure the performance of leech therapy in conformity with the law. The information below provides important points of reference. In addition to abiding by the general rules of good treatment practice, persons administering leech therapy must consider important legal aspects of treatment. Leech therapists can be confronted with liability, regulatory, and criminal law problems, which pose legal risks to the profession. Patients expect to receive the best possible treatment with safe and effective drugs. This chapter outlines the legal issues specifically related to leech therapy. General responsibilities of healthcare professionals are not included. • What is the legal status of leech therapy under drug law regulations? • What qualifications must a leech therapist have in order to administer the treatment? • Is the leech therapist adequately informed about potential risks? • Has the patient been properly informed about how to recognize potential side effects? • Do animal and environmental protection rules apply? • What legal requirements apply to the disposal of used leeches? The Pure Food and Drug Act, also known as the Wiley Act, was passed in the USA in 1906, creating a uniform national legislation for the food and drug sector. In 1938, the Wiley Act was abrogated and substantially amended and replaced by the Federal Food and Cosmetic Act, or Copeland Act, which is still in force today [1]. The Federal Food, Drug and Cosmetic Act itself has meanwhile been amended [7]. The aforementioned legislation lays down the statutory requirements, not only for foods and cosmetics, but also for drugs and medicinal products. Today, proof of quality, efficacy, and safety of drugs and medicinal products prior to their being placed on the market is statutorily regulated by comparable high-quality approval procedures in both the USA and the EU. The harmonization of drug laws within the EU commenced with the passage of Council Directive 65/65/EEC in 1965 [2]. Considerable aspects of drug law in the EU were extensively harmonized by various later directives. EU directives are to be implemented in form and content via the national legislation of the Member States. Further requirements may apply in the Member States as long as they do not obstruct the free movement of goods and are in conformity with the EU constitution. Unlike the USA, the different Member States of the EU have different national regulations for foodstuffs and medicinal products, the basic standards of which, however, are identical. The EU system of drug law has a three-part structure: 1. EU-wide regulations that apply throughout the EU and which are enforced and controlled by the EU. 2. National regulations that apply in a given country and which are nationally controlled but are mutually recognized by several other EU Member States. 3. National regulations that apply only in a given country and are nationally controlled by that country. This three-part structure can also be seen in the framework of the alternative approval procedures in the EU. In addition to receiving approval for certain drugs by the EU administration (central authorization procedure), it is also possible to receive national approval (decentralized authorization) for various drugs from an EU Member State with a mutual recognition procedure that allows for the extension of medicinal product approvals to other EU Member States. Unlike the USA, regulations for drugs [2] and medicinal products [4] are regulated by different legal norms in the EU.
What is the Legal Status of Leech Therapy?
Summary Comparison of Drug Law and Medicinal Products Law of the USA and the EU and the Implications for Leech Therapy
USA
EU
Current Legal Status of Medicinal Leeches as Drugs/Medical Devices in the USA and EU
USA
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