Pharmaceuticals Policy and Law

The aim of this study was to assess the activities of the National Competent Authorities (NCAs) in Europe regarding their distribution of drug information to the general public, in particular via the Internet. An electronic questionnaire was sent to all Heads of Medicines Agencies (HMAs) in the European Union and Norway, Iceland and Liechtenstein concerning their provision of drug information to the general public during the previous 12 months. The focus was on the availability of basic drug information, Summaries of Product Characteristics (SPCs) and/or Patient Information Leaflets (PILs), on the Internet. Twenty-four replies out of 28 were received. Where there was no response from the NCA, the website was searched by the researcher. In November 2005, 17 NCAs published SPCs on their websites, while ten NCAs did not. PILs were found on the websites of 12 NCAs, but 15 NCAs did not have PILs on their websites. Four NCAs had a special drug information section for consumers on their website. Other activities included publishing magazines or newspapers (8 countries), leaflets (7 countries), organising campaigns (7 countries) and publication of press releases and/or reports (4 countries), books on medicines (3 countries), publication in magazines (1 country) and a list of registered medicines (1 country). Our results show, that NCAs do produce and distribute drug information. Since almost half of the population of the European Union has access to the Internet, the existence of valid drug information available also on the Internet is essential.

The borderline between medicinal products and food supplements is an issue which cannot be solved merely by legislation. The interpretations of the European Court of Justice are therefore important for understanding the underlying problem. Medicinal products are classified by two aspects. Products, which are presented as being a medicine, are by definition to be classified as a medicine. And products, which contain substances that are used with a view to restoring correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or to making a medical diagnosis, are also to be classified as a medicine.

In its interpretations of the borderline the European Court of Justice came to the following conclusions:

The evaluation of a product has to be performed on a case-by-case basis taking into account its pharmacological properties. If a product falls equally well under the definition of a medicinal product and under the definition of another product group, the definition of a medicine applies. Therefore Member States may classify a product as medicinal product (even if food supplement in another) if all characteristics of both medicinal products and food supplements are equally well met.

The risks of substances and nutrients have to be evaluated on a case-by case basis by the Member State. Therefore multiples of RDAs are no means of setting maximum levels for food supplements. The burden of prove is generally with the Member States.

A complete ban is only justified if in the interest of public health and/or consumer protection. And the absences of nutritional need no justification for ban of a product.

This essay is concerned with wholesalers who import and supply unlicensed medicines within the EU on a “named patient” or “special needs” basis – i.e., on the basis that a physician has specially ordered an unlicensed medicine for the treatment of a particular patient. In particular it looks at the position of a wholesaler who supplies such medicines from a British offshore island (the Isle of Man) to Germany.

For most purposes, the law governing pharmaceutical wholesaling is in practice identical in the UK (which is an EU member) and on the Isle of Man (which is not). The essay does however consider the specific regulatory position of wholesalers trading from the Isle of Man by virtue of the Island's right to partake in the EU internal market for goods as a result of the UK Treaty of Accession.

The application of Information and Communication Technologies to clinical activity gives rise to electronic health and clinical records. In this way clinical information comes to take part in a health information system and is a source of data for the management of knowledge, epidemiology and health care planning. The primary consequence of the electronic health and clinical record is the improvement in continuity and quality of health care.

This essay reviews the requirements for the electronic health and clinical record (identification of persons, integration of information and compliance with the norms of security and confidentiality). It also summarises the consequences of using the electronic health and clinical record: the improvement in continuity and quality of health care as well as the greater availability of clinical information as a source of knowledge. Special mention is made of the opportunity to enhance the clinical management of medicinal products (prescription, dispensing and evaluation); this, too, benefits from the electronic prescription, provided that this is considered a clinical document closely connected to the electronic clinical record.

Haemophilia is a hereditary bleeding disorder, which mainly causes bleedings into joints and muscles as well as – untreated – premature death from intestinal or cerebral bleeding in affected patients. The treatment of Haemophilia is the intravenous injection of the missing or decreased coagulation factor (VIII or IX) to achieve sufficient blood coagulation to stop bleeds and to prevent secondary haemorrhage. A person suffering from haemophilia does not bleed faster than anyone else, but bleeding lasts longer. Persons with Haemophilia (PwH) can bleed internally or externally. Severely affected individuals experience spontaneous bleeds an average of 35 times a year [1].

Non- viral- inactivated- concentrates caused a pandemic of HIV/ Aids and HCV (Table 1) within this population in the 1970ies and late 1980ies. In this time the public and political awareness concerning this group of patients was rather high, as the iatrogenic infections caused numerous lawsuits and negotiations between patient organisations, pharmaceutical industry and national governments/health care providers, insurances, etc.

Today plasma derived as well as genetically engineered clotting factor concentrates are available, safe and efficacious, strict legislation on blood safety became standard in most countries.

Whilst the care provided for patients with Haemophilia in some EU Member States can today be sited globally as examples of best practice, there are still definite disparities between the levels and quality of care available to PwH in the European Union.

Between April and July 2005, the European Haemophilia Consortium (EHC) carried out a series of interviews among EU policy-makers with the aim of establishing the level of understanding and awareness of haemophilia that exists amongst EU policy makers. The responses were treated anonymously, so no explicit reference is made in this report to the individual answers given by interview partners.

Europe, traditionally, has been the leading power in the field of medicinal products. Over the last 20 years it has been gradually losing its competitiveness and, at the moment, needs urgent measures to be taken in order to relaunch its innovation, which forms the basis of the sector.

Pharmaceutical policy needs a law on medicinal products which assures, every patient, that the medicinal products which are authorised onto the market are of a high quality, safe and efficient. Medicinal products condition all areas of healthcare policy. Its efficient use poses a challenge for healthcare systems. However, in addition to the scientific and healthcare dimensions of medicinal products, there is an important economic element.

In the member states of the EU there are systems of solidarity and social security which, in one form or another, assure collective funding. This adds complexity to the Governments’ control over them, to which can be added industrial and investigation policies that are already in place.

Without forgetting that in the complex world of medicinal products, developed democratic societies are strongly influenced by social judgements and prejudices which can seriously harm their development. Moreover there are increasing aggressive ascientific trends by a socio-political mentality which unbalances society, favouring alternative models, without any reasoning or rationale. They are simply based in a supposed personal freedom which, minorities are imposing on the majority of society. Anything done in one particular country has repercussions on the rest. The magnitude and weakness of medicinal products is that they are essential merchandise on a global level and are efficient tools in the preservation of human health.

In this context we shall seek to summarise the essential elements of the law on medicinal products in the EU as a fundamental axis in the pharmaceutical policy of the EU. We shall then move on to examine the economic, social and ascientific aspects that condition it.