Marie-Hélène D.B. Schutjens

Barriers to access to opioid medicines : a review of national legislation and regulations of 11 central and eastern European countries

Control measures designed to prevent the misuse of opioid medicines can often unintentionally restrict legitimate medical use, leaving patients with cancer in pain. This study aimed to develop and validate an assessment instrument based on WHO policy guidelines to systematically identify legal and regulatory barriers to opioid access in 11 European countries (Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Serbia, Slovakia, Slovenia, and Turkey) as part of the Access to Opioid Medication in Europe project. Relevant legislation and regulations were independently assessed by three reviewers and potential barriers were identified within nine categories including prescribing, penalties, and others. Potential barriers were identified in all countries, ranging from 22 potential barriers (Cyprus) to 128 potential barriers (Lithuania). The total number of barriers in a single category varied from one (Slovenia, usage category) to 49 (Greece, prescribing category). Differences, such as prescription validity, varied within one category, ranging from 5 days (Hungary) to 13 weeks (Cyprus). The results of this Review should give rise to a national review and revision of provisions that impede access to opioids, disproportionate to their (intended) benefit in preventing misuse, in these 11 European countries.

Legal Barriers in Accessing Opioid Medicines: Results of the ATOME Quick Scan of National Legislation of Eastern European Countries

CONTEXT Overregulation of controlled medicines is one of the factors contributing to limited access to opioid medicines. OBJECTIVES The purpose of this study was to identify legal barriers to access to opioid medicines in 12 Eastern European countries participating in the Access to Opioid Medication in Europa project, using a quick scan method. METHODS A quick scan method to identify legal barriers was developed focusing on eight different categories of barriers. Key experts in 12 European countries were requested to send relevant legislation. Legislation was quick scanned using World Health Organization guidelines. Overly restrictive provisions and provisions that contain stigmatizing language and incorrect definitions were identified. The selected provisions were scored into two categories: 1) barrier and 2) uncertain, and reviewed by two authors. A barrier was recorded if both authors agreed the selected provision to be a barrier (Category 1). RESULTS National legislation was obtained from 11 of 12 countries. All 11 countries showed legal barriers in the areas of prescribing (most frequently observed barrier). Ten countries showed barriers in the areas of dispensing and showed stigmatizing language and incorrect use of definitions in their legislation. Most barriers were identified in the legislation of Bulgaria, Greece, Lithuania, Serbia, and Slovenia. The Cypriot legislation showed the fewest total number of barriers. CONCLUSION The selected countries have in common as main barriers prescribing and dispensing restrictions, the use of stigmatizing language, and incorrect use of definitions. The practical impact of these barriers identified using a quick scan method needs to be validated by other means.

Extensions of indication throughout the drug product lifecycle: a quantitative analysis.

The marketing authorisation of the first generic product version is an important moment in a drug product lifecycle. The subsequently changed intellectual property protection prospects could affect the incentives for further drug development. We assessed the quantity and nature of extensions of indication of small molecule medicinal products authorised through the European Medicines Agency throughout the drug product lifecycle with special attention for the impact of the introduction of a first generic competitor. The majority (92.5%) of the extensions of indication was approved during the exclusivity period of the innovator product. Regulatory rethinking might be needed for a sustainable stimulation of extensions of indications in the post-generic period of a drug product lifecycle.

De nieuwe Geneesmiddelenwet

SamenvattingOp1 juli 2007 is de Geneesmiddelenwet in werking getreden. Deze wet is de opvolger van de Wet op de geneesmiddelenvoorziening die uit 1963 stamde. De overgang naar een nieuwe wet is vrij vloeiend en zonder veel ophef verlopen. Dat is ook niet zo verwonderlijk, omdat de oude wet in de loop van ruim veertig jaar al zeer vaak was aangepast aan de actuele ontwikkelingen in praktijk en internationale (juridische) ontwikkelingen en de meeste wijzigingen inhoudelijk gezien dus niet zo groot waren. In feite is de Geneesmiddelenwet te zien als een modernisering van de oude wetgeving, waarbij vereenvoudiging, herschikking en herformulering tot een voor de praktijk beter toegankelijk kader hebben geleid. Toch heeft de parlementaire behandeling van de wet lang geduurd: het wetsvoorstel is al in december 2003 ingediend.

Patent law and pharmaceutical products: A comparative study of the legal aspects of medical-pharmaceutical inventions in patent law

Introduction A paradoxical relationship exists between patent law and inventions in the medical-pharmaceutical field. On the one hand, the innovation-stimulating function of patent law is of great importance to both public health and the innovative pharmaceutical industry. On the other hand, however, the exclusive rights which derive from patent law may lead to restrictions as to the affordability and accessibility of a patented invention, particularly when the invention is in the medical-pharmaceutical field where the consequences of those exclusive rights which are derived from patent law are considered undesirable. The question as to how the balance between the public interest (especially the interest of public health) and the individual interest (the interest of the patentee) can be achieved and maintained is at the centre of the present study. More specifically the formulation of the problem reads: in what way is the balance in patent law being influenced by the fact that a specific invention is situated in the medical-pharmaceutical field, and in what way can any disturbance of the balance, should it arise, be restored? In order to answer these questions, an examination of the legislation, case law and legal literature both on a national level (the Netherlands and Germany) and on the international and supranational level (within the framework of the various patent treaties) has been undertaken. Where it was necessary, attention has also been paid to specific regulations in other countries, such as Great Britain, Sweden, the United States and Canada. Because of the fact that patent law is strongly influenced by various international treaties, investigations were performed against the background of the international pursuit of the unification and harmonization of patent law.

Informatie en reclame over geneesmiddelen

In dit hoofdstuk wordt ingegaan op de regels voor communicatie over geneesmiddelen, waarbij communicatie uiteenvalt in twee categorieen: informatie en reclame.