Life Sciences Review
August, 2013 - Mikkel Vittrup and Mette Hygum Clausen1
Denmark has a large life science sector, including a number of biotech and pharmaceutical companies and research activities. The sector is highly regulated and covered by extensive and complicated statutory requirements, executive orders and ethical standards. Denmark has incorporated most of the EU regulation and Danish law is thus to a large extent in conformity with the general EU regulation and practice of, for example, the European Medicines Agency (‘EMA’). However, there are exceptions, including the Danish price and reimbursement system, please see paragraph III.
The national competent authorities are the Danish Health and Medicines Authority (‘DHMA’) and the Danish Ministry of Health. The legislative basis for oversight and enforcement may be found in the Danish Medicines Act (‘the Medicines Act’), the Danish Pharmacy Act, the Danish Health Act and the Act concerning Medical Devices and the underlying executive orders.
II THE REGULATORY REGIME
i Classification
The definitions of and the distinctions between medicines, medical devices and other regulated products are to a large extent based on EU regulation. Medicines are defined in the Medicines Act, Section 2, as:any product that (i) is presented as a suitable product for the treatment or prevention of disease in human beings or animals, or (ii) may be used in or administered to humans or animals to restore, change or modify physiological functions by having a pharmacological, immunological or metabolic effect or to make a medical diagnosis.
Thus, medicines are defined by two independent definitions, based on either the designation or the function of the product. The definition is in accordance with Directive 2001/82/EC2 and Directive 2001/83.3 The definition of medical devices corresponds to the definition in Directive 1990/385/EEC, Article 1(2)(a),4 which states that a ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. Likewise, the definition of cosmetic products5 and food supplements6 corresponds to the definition in the relevant directives. The DHMA determines whether a product can be considered to be a medicine or a medical device. The rules concerning cosmetics and food are administrated by other authorities.
ii Non-clinical studies
Conducting toxicological and pharmacological trials (non-clinical trials) with a view to assessing the safety of medicinal products for the purposes of applying for clinical trials, applying for marketing authorisation or maintaining the marketing authorisation may take place only following the authorisation of the DHMA, see Section 85 of the Medicines Act. Studies on animals must also be approved by the Animal Experiments Inspectorate if they are expected to cause pain, suffering, distress or lasting harm to the animals. Studies on animals are governed by the Act on Animal Testing administered by the Ministry of Justice. The DHMA performs inspections in order to ensure that non-clinical studies are performed in compliance with the OECD Principles of Good Laboratory Practice (‘GLP’).
Footnotes:
Reproduced with permission from Law Business Research Ltd.This article was first published in The Life Sciences Law Review, 1st edition(published in April 2013 – editor Richard Kingham).For further information please email[email protected] |
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