The law of Europe relating directly to bioscience issues can be conveniently discussed under four separate headings: (i) Pharmaceuticals; (ii) medical devices; (iii) food processing and content; and (iv) genetically modified organisms. Bioscience issues are often closely interrelated with legal issues involving intellectual property, consumer and environmental protection and commercial law. (Please see Chapters on "Environmental Law", on "Product Liability" and on "Intellectual Property, Information Technology, E-commerce"). Account may also need to be taken of various international treaties, such as (among others) the European Patent Convention (1973) (and national patent laws), the TRIPs Agreement (1994), the European Convention on Human Rights & Biomedicine (1997) and the Cartagena Protocol on Biosafety (2000), as well as national trademark laws and Directive 89/104/EEC (EU Directive on trademarks

Pharmaceuticals. It has long been the goal of the EU to achieve a single market for Pharmaceuticals. As long ago as 1975, the EU established a Pharmaceutical Committee (Council Decision 75/320/EEC) and a Committee for Proprietary Medicinal Products (CPMP) (Directive 75/319/EEC replaced by Directive 2001/83/EC), with the goal of achieving approximation of the national laws relating to medicinal products.

Directive 93/39/EEC (replaced by Directive 2001/83/EC) set forth arrangements for the EU member countries to implement harmonised procedures for the cross-border mutual recognition of their national marketing authorisations for medicinal products and Regulation 2309/93 set forth a centralised procedure for the authorisation of biotechnology-derived and innovative medicines, whereby there is a single application, a single evaluation and a single authorisation for medicinal product marketing within the entire EU.

The centralised procedure is mandatory for medicinal products developed by recombinant DNA technology, through controlled expression of genetic coding for biologically active proteins in prokaryotes and eukaryotes and by hybridoma and monoclonal antibody methods. Approval by the EMEA (European Agency for the Evaluation of Medicinal Products, established by Regulation 2309/93) is based upon the opinion of the CPMP, which must be given within 210 days of the receipt of a valid application. The centralised procedure came into operation in 1995 and (as of April 2003) the EMEA had received 380 marketing authorisation applications of which 243 authorisations have been granted.

There is also an abridged application and approval procedure for marketing authorisation (e.g., based upon a prior authorisation and/or reference to scientific literature, in lieu of renewed clinical tests), albeit such exemptions can be expected to be applied narrowly in the case of generic products (In re Scotia Pharmaceuticals (Case 440-93, decided 5 October 1995) [1995] ECR 1-2851)) and with a heavy burden of proof on the applicant or "me too" applicant (Smith Kline & French v. UK Licensing Authority, 2 CMLR) [1989] 138 ("Tagamet" case).

Following the success of the Orphan Drug Act in the USA, the EU has implemented a similar regime through Regulation 141/2000 on orphan medicinal products. The Regulation sets out a procedure for the designation of orphan medicines and provides incentives for companies to develop orphan drugs, such as granting them ten years of market exclusivity. An application for orphan status must be submitted to the EMEA prior to filing an application for a marketing authorisation. So far, three years after the introduction of the regime in the EU, the Committee for Orphan Medicinal Products (COMP) has adopted over 140 positive opinions and ten orphan medicinal products have received marketing approval through the European centralised procedure.

Directive 2001/83/EC sets out a code for a broad range of human medicinal products and, in essence, replaces and repeals a number of prior pharmaceutical Directives.

Medicinal products are included in the coverage afforded by the Product Liability Directive (Directive 85/374/EEC) and national courts have been active in applying such legislation, for the protection of consumers. See, for example, the UK hepatitis C case of A. v. National Blood Authority [2001] 3 All E. R. 289 where the court held under the Directive and the implementing law, the Consumer protection Act 1987, that contaminated blood gives rise to a cause of action even if the contamination was unavoidable.

For various legal purposes (including manufacture, importation and sale), a central question in this field is "what is a medicinal product?" Directive 65/65/EEC (replaced by Directive 2001/83/EC) sets forth two criteria: (i) how the product is presented to the marketplace or (ii) how the product functions (meeting either test is sufficient to be a medicinal product). The presentation criterion is interpreted broadly (and covers both effective and ineffective products, if presented as medicinal). In Van Bennekom (Case 227/82, decided 30 November 1983) [1983] ECR 3883, the function test results in the law being applicable to products which by their intended function are administered in connection with a medical diagnosis or with a view to treating some ailment or physiological disorder, while in Upjohn v. Farzoo (Case 112/89, decided 16 April 1991) [1991] ECR 1-1703 it is any substance capable of having an effect on the functioning of the body. Even classification in the European Pharmacopoeia can be enough to constitute a medicinal product (EC v. Germany (Case 290/90, decided 20 May 1992) [1992] ECR 1-3317 (eye lotion).

In fact, EU law (and for that matter the law in non-EU European countries) is substantially harmonised, covering vaccines, toxins, serums, allergens, products derived from human blood and homeopathic medicinal products (Directive 2001/83/EC). There are also detailed EU laws regarding labelling (Directive 92/27/EEC, replaced by Title V of Directive 2001/83/EC), advertising (Directive 92/28/EEC, replaced by Title VIII of Directive 2001/83/EC) and distribution (Directive 92/25/EEC, replaced by Title VII of Directive 2001/83/EC) of marketed medicines. All such EU laws have been implemented into national legislation. For example, as far as the labelling Directive is concerned, in the UK it is the Medicines (Labelling) Regulations 1976 (as amended), whereas in Germany it is Article 11 of the AMG (Arnzeimittelgesetz of 1994, "Law on Medicinal Products").

Directives 87/18/EEC and 88/320/EEC set out the principles of good laboratory practice for conducting non-clinical tests (toxicological and pharmacological tests). The subjects of clinical trials and ethics committee and regulatory approvals are addressed in the ICH Guideline for Good Clinical Practice and EU laws (and in their national law analogues), specifically in Directive 2001/20/EC providing a common regulatory framework for clinical trials conducted in the EU on human subjects. National laws, such as the French "Law Hurriet" of 1988 (Law No. 88-1138 of 20 December 1988), which were in advance of EU legislation on the subject of human clinical trials can be expected to be superseded by the new EU secondary legislation.

Directive 98/44/EC contains detailed rules regarding the patenting of biotechnological inventions which, as of April 2003, had only been specifically implemented in national legislation by Denmark, Finland, Greece, Ireland, Spain and the UK. The Directive does not explicitly address the patentability of inventions involving human embryonic stem cells. Stem cell research offers great therapeutic potential, but has raised strong ethical questions. The European Group of Ethics published its opinion on 7 May 2002 advising the European Commission that strict controls should be enforced so that patents should only be issued on human stem cell lines that have been modified to create new characteristics for specific industrial applications. The UK Patent Office issued guidance in April 2003, clarifying the UK's position and permitting the grant of patents for inventions concerning certain types of cells for therapeutic purposes.

In some countries (such as Poland and Hungary), there may be limited possibilities for Bolar exemptions (that is, limited exemptions from national patent law, in order for research and development work to be done). Such exemptions are named after a US case upholding such an exemption. Roche v. Bolar, 733 F. 2d 858 (Fed. Cir. 1984). In two more recently decided cases, the German Supreme Court has ruled that clinical testing of a patented drug during the patent term was not infringement, on the basis that the clinical testing was for the purpose of seeking to discover new uses for the substance. Klinische Versuche I (BGH) Az: X ZR 99/92 [1995] (decided 11 July 1995) and Klinische Versuche II (BGH) Az: X ZR 68/94 [1997] (decided 17 April 1997). Courts in Denmark and Spain have tended to follow this line of thinking, whereas courts in France, the Netherlands, Sweden and the UK have not.

Research into new applications for medicinal products has another notable legal ramification, known as the "Swiss-type" claim (allowing second and further medical applications to be patented, without per se fulfilling the novelty requirement of Article 54 of the European Patent Convention). Bayer EISAI (Case G 5/83) (OJ 1985, 64).

Medical Devices. A second goal has been to establish an EU-wide legal framework for the marketing of medical devices.

The term "medical device" covers any instrument, apparatus, appliance, material, including software, used in healthcare, for the diagnosis,

monitoring or treatment of disease or injury, or the investigation of the anatomy/physiological process, with the exception of medicines.

Medical devices are regulated by three European Directives ("New Approach Directives"). These are the Active Implantable Medical Devices Directive 90/385/EEC, the Medical Devices Directive 93/42/EEC and the In Vitro Diagnostic Medical Devices Directive 98/79/EC. The Directives are implemented in national legislation: for example, for the UK it is the "Medical Devices Regulations 2002" which consolidate the three regulations.

EU member countries must appoint competent authorities, whose main role is to ensure that medical devices comply with relevant Directives. National regulators are responsible for the designation of "Notified Bodies", the assessment of notifications for clinical trials, the registration of manufacturers of certain types of devices, and the vigilance system for evaluating and dealing with adverse incident reports. Notified Bodies are independent assurance bodies who conduct testing of the products and audits under specified conformity assessment procedures. The European Commission publishes a list of Notified Bodies in all member countries and other countries with which the EU has concluded Mutual Recognition Agreements on conformity assessment and acceptance of goods.

Medical devices must carry the CE Mark when they are placed on the market. By affixing the CE Mark, manufacturers of medical devices confirm that their products comply with EU laws. Some medical devices are exempt from this requirement, for example, devices undergoing clinical investigation. The CE Mark gives guaranteed access to an EU-wide market. Please also see Chart on page 11 and definition in the Chapter on

"European Legal Terms". i


Before placing a product on the market, a manufacturing company should take the following steps: determine whether the product is a medical device; determine the class of the device; determine which regulatory requirements ("essential requirements") must be met and which conformity assessment route to follow, in order to demonstrate regulatory compliance. Medical devices are classified and regulated according to the level of risk, so that the strictest controls are applied only to those devices which present the highest risk to health and safety. The essential requirements cover

aspects of product design, safety and performance from risk analysis and product evaluation to biological, mechanical and electrical safety, infection and microbial contamination and labelling. The essential requirements aim to ensure that the products do not compromise the clinical condition or the health and safety of patients and users and achieve the intended purpose. Compliance with harmonised European standards creates a legal presumption of conformity with the essential requirements.

The Directives also contain rules regarding the conduct of clinical investigations. They set out the required procedure and require notification by manufacturers, or their authorised representatives, of the regulatory authority of the member country in which the investigation is to be carried out.

Advertising and promotion of medical devices are not specifically covered by the Directives but through industry self-regulation and by various EU and national laws that, in general, apply to advertising and consumer protection.

Food Processing & Content. There is sometimes room for doubt, as to whether a particular substance is a foodstuff or is a medicinal product but, in most cases where it is clear what qualifies as a foodstuff, there are numerous EU laws which apply to its labelling, content and sale.

Directives 79/112/EEC, 97/4/EC and 2002/67/EC address the labelling and advertising of foodstuffs, whereas Directives 2002/71/EC and 2002/79/EC address specific issues regarding maximum pesticide residues in foodstuffs. Regulation 258/97 sets forth rules regarding novel foods and ingredients intended for human consumption. Regulations 2081/92 and 2073/93 focus on the protection of geographic designations of certain foodstuffs.

Directive 2002/46/EC harmonises national laws as to vitamins and minerals which are marketed as foodstuffs, for the purpose of supplementing the normal human diet.

As in the case of medicinal products, there are detailed national laws regarding food safety and content. In the UK, for example, the Food Standards Act 1999, the Food & Environment Protection Act 1985, the Food Safety Act 1990, just to enumerate a few of the major legislative food

safety frameworks, with extensive food labelling provisions being found in the Food Labelling Regulations 1996. As in other European countries, the UK regulations address specific issues such as the listing of ingredients and additives and their quantities, durability indications ("best before" and "use by" dates), misleading descriptions and designations of geographic origin.

The foregoing is merely a set of examples of laws that apply to foodstuffs and is not comprehensive.

Genetically Modified Organisms. The EU (and in turn the individual member countries) focus on GMOs in two interrelated ways, (i) regulating or forbidding their introduction into products which may be consumed by people or by animals and (ii) protecting the environmental against their release and dissemination.

Directive 2001/18/EC regulates the release into the environment of genetically modified organisms and Directive 90/219/EEC addresses the contained use of genetically modified micro-organisms.

All European countries have (or are in the process of enacting) laws requiring that GMO content in food be clearly labelled and certain countries have banned altogether certain grain products which have been genetically modified.

Interesting Europe-fact: Some special Swedish employment law terms: December Compromise ("Decemberkompromissen"), a foundation stone of Swedish industrial relations, whereby, as agreed in December 1906, the employees have the right to organise but the employers retain prerogatives regarding the overall running of the business. 29:29 Principles ("29:29 Principerna"), a name for the rule, first set forth by the Labour Court in Ruling 29, in 1929, describing the employee's duty to work on assigned projects

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