This article discusses a number of internet sources for those who wish to stay up to date with pharmaceutical law.  It includes sources with an international, European, and/or national scope. It includes both governmental or public sources, and private sources of pharmaceutical law. It does not intend to be exhaustive. 

Legal provisions
European Union

The European Union has produced a considerable body of legal provisions – mostly Regulations and Directives – which are published in the Official Journal of the European Communities. These legal provisions can be accessed online via the Eurlex portal of the European Union. Eurlex has a number of search options. An easy way to search for pharmaceutical legislation is the option ‘Simple search’, which allows a search by keyword, or in case the document number is known, the natural number. A very useful feature of the ‘Simple search’ option is the possibility to search for consolidated texts. With this option up to date versions of legislation incorporating all amendments can be found. Unfortunately, this only regards officially published consolidations, which means that not all amended legislation can be found via this option.

The Eurlex portal does not only include legislation. It also provides a good means to search for case law of the European Court of Justice, as well as legislation in preparation and parliamentary questions.

In addition to the Eurlex portal the European Commission provides specific information on pharmaceutical legislation on the website of the Directorate General Enterprise. It provides an impressive collection of European sources of pharmaceutical law. For those not acquainted with (European) pharmaceutical legislation, the Summaries of EU Legislation for Beginners is to be recommended.

National rules
Nowadays virtually every Member State has made its pharmaceutical rules available via the internet. With respect to the rules on homeopathic and anthroposophic medicinal products, the ECHAMP website provides a good overview of the applicable national rules per Member State. In addition, it provides links to national health ministries and medicines agencies in the 27 Member States, most of which give direct access to the applicable legal rules on medicinal products.

Guidelines
Next to these sources of pharmaceutical law, guidelines exist to further substantiate the legal norms. On an international level, Europe, the United States and Japan work together to establish a certain level of uniformity in pharmaceutical requirements via the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Many ICH guidelines find their way to European and national rules and practices. The website of the ICH provides a large body of information.

At a European level reference should be made to the websites of the European Medicines Agency (EMEA) and again the European Commission. For example, the EMEA website contains all relevant guidelines on Pharmacovigilance, such as the Distribution Requirements and Address Lists for Periodic Safety Update Reports (PSURs) of 19 September 2008.

Most Member States provide internet access to their guidelines as well via the websites of their medicines agencies. The ECHAMP website provides a complete list with links to these agencies, many of which provide information in English such as for example the website of the German Federal Institute for Drugs and Medical Devices, the BfArM.

Case law
Case law or court decisions form an important source of law, since these give (ultimate) guidance on questions of interpretation of the Law. Regrettably, the availability of case law on the internet is still rather limited. A good exception to the rule is the case law of the European Court of Justice (ECJ), or with respect to cases before 1989 via the Eurlex portal. On the website of the ECJ one can make use of a ‘search form’ that is located under the heading ‘case-law’. Furthermore, the Court’s diary offers the possibility to stay informed on future decisions, opinions, and hearings.

At national level case law is still hard to find. In some Member States recent case law is available, however mostly offered by private organisations as a paid service. In France for example, one can access a considerable number of cases via www.juris-classeur.com, or www.dalloz.fr as paid services. A comparable site in Germany is www.juris.de. In both Member States case law is only available in the national language. In the Netherlands, one can access a good service free of charge which includes a broad compilation of cases since 1999. It is however not complete and only available in Dutch.

With respect to national case law much still needs to improve. For those not mastering a specific language, it may be helpful to search for comparative legal studies in books or legal periodicals.

Legal periodicals
Most Member States have legal periodicals with a special focus on pharmaceutical law issues. Few of these journals are available electronically via the internet. Certain journals with a European or international focus are accessible via the internet as paid services. Examples of these are: Euralex, and Pharmaceuticals Policy and Law. Many of these journals have a rather theoretical/academic approach, and are therefore not always very useful for commercial purposes. Euralex on the other hand has a strong focus on the more practical side of pharmaceuticals regulation.

Law firms
Certain law firms publish newsletters addressing pharmaceutical legal matters. Often these newsletters give a good insight in recent national, European, and/or international novelties. However, the information that is displayed is not sufficiently detailed. Moreover, only a restricted part of these newsletters is dedicated to pharmaceutical law issues. Therefore while newsletters from law firms can be useful, they do have their limitations as well. Click here for an example of a newsletter.

Other sources
There are many non-governmental or private organisations that give attention to, or even focus on issues related to the regulation of pharmaceuticals. Some provide professional training such as Topra, others such as EurActiv provide more political information. It would be impossible to compose a list of such organisations. Nevertheless, it is advisable to access the websites of the European interest groupings in the field of pharmaceuticals.

ECHAMP for example is the most comprehensive source of information on the regulation of homeopathic and anthroposophic medicinal products in Europe, probably much better informed than the European institutions on this topic. For over-the counter remedies (self-medication remedies) a valuable source of information is the website of AESGP. AESGP has published a most interesting publication on ‘Smart Regulation’. Finally, the European Generic Medicines Association (EGA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), the associations for generics and specialities, tackle issues like the relationships between industry and patient organisations, and the legislative aspects of Biogenerics.

As has been shown above, the internet gives a good general insight into the sources pharmaceutical law that are available in Europe. Though it would be insufficient to rely solely on this source of information, it allows those who are interested to keep up with most legal and regulatory developments in the field of pharmaceuticals. 

Johan Hulshof
Van Benthem & Keulen Advocaten