The application of specific performace in contractual relationships.
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In the European Union (EU), medicines can be marketed only after they have been authorised. However, some medicines need to be accessible before they have been authorised. This especially applies to medicines, which are expected to benefit severely ill patients who cannot be treated with authorised medicines or who have a disease for which no medicine has been authorised yet. The treatment with unauthorised medicines may be the last chance for patients who suffer from rare diseases and cannot enrol in an ongoing clinical trial or be treated with a potentially life-saving medicine. The aim of this article is to analyse the aspects of the legal regulation of access to unauthorised medicines for such patients. The fact that 27–36 million patients with rare diseases live in the EU and there are approximately 200,000–240,000 of such patients in Lithuania underlines the relevance of the study. The first part of the article analyses the EU legal provisions, which govern the so called “named patient” programmes for single patient use under the Article 5 of Directive 2001/83/ EC (ex Article 3.1 of Directive 1989/341/EEC) and “compassionate use” programmes for a group of patients set out in the Article 83 of Regulation (EC) No 726/2004. Upon the introduction of these legal exceptions into the national law, medicines intended for the treatment of rare diseases can reach patients more quickly and easily. The national legal regulation of patient access to unauthorised medicines differs by country, because EC regulations define only the general principles. The civil law tradition considers specific performance the primary remedy for non-performance of obligations, as opposed to awarding damages and termination of contract. In recent years, creditors have rarely sought specific performance due to its costly and complex enforcement. This article focuses on whether specific performance is still efficient in legal practice. Since the fulfillment of monetary obligations is always possible in specie, the article deals with the fulfillment of non-monetary obligations and the enforcement of the court order of specific performance. Moreover, this article focuses on the general rules of specific performance in contract law and also analyses the possibility of demanding the fulfillment of obligations arising from a lease agreement—as lease agreements are distinguished by their continuing performance of obligations being a crucial part of successful commercial practice.
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