Legislation

In recent years Research and Innovation (R&I) activities within the Andalusian Public Healthcare System (SSPA) have increased substantially in terms of the quality and quantity of outcomes obtained. This has become possible thanks to the effort and the scientific and technical standards of the professionals who provide their services at the SSPA, as well as the investments made and the legal framework promoted by the Government of the Andalusia.

Furthermore, the Andalusian Government has made a clear commitment to promoting R&I in biohealthcare with the development of an extensive set of regulations that favour investment and have given Andalusia and its healthcare system a leading position in areas such as advanced therapies and technology transfer.

Below follows a list of most of the legislative framework that has been developed in our autonomous community in recent years, and also key national and European laws which support biomedical research and also the protection and transfer of research outcomes arising from these activities.

Industrial Property

Intellectual Property

Research Outcome Transfer

  • Agreement of 28 April 2010 between the Andalusian Health Service and the Fundación Progreso y Salud (FPS) whereby the FPS is entrusted with the management of rights and outcome transfer that result from health science research carried out in the Andalusian Health Service's centres and services.
  • Decree 16/2012, of 7 February, regulating the management and transfer of the outcomes of research, development and innovation activities, the ownership of which belongs to agencies and other bodies depending on the Regional Ministry responsible for health.

Advanced Therapies

  • Act 14/2007, on biomedical research
  • Directive 91/356/EC, of 13 July, establishing the principles and guidelines for good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
  • Directive 2001/20/EC, of 4 April, for the approximation of the laws, regulations and administrative provisions of member countries relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
  • Directive 2003/94/EC, of 8 October, establishing the principles and guidelines for good manufacturing practice in respect of medicinal products for human use and investigational research products for human use
  • Directive 2003/63/EC, of 25 June, establishing the Community code in respect of medicinal products for human use and amending Directive 2001/83/EC
  • Regulation (EC) Nº 1394/2007, of 13 November, on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation EC 726/2004
  • Royal Decree 1301/2006, of 10 November, establishing quality and safety standards for the donation, collection, examination, handling, preservation, storage and distribution of human cells and tissues and enactment of the regulations for coordination and operation of their use on humans
  • Royal Decree 223/2004, of 6 February, regulating clinical trials with medicinal products
  • Royal Decree 1344/2007, of 11 October, regulating pharmacovigilance of medicinal products for human use
  • Royal Decree 2183/2004, of 12 October, modifying Royal Decree 1564/1992 for the development and regulation of the authorisation progress for pharmaceutical laboratories and importers of medicinal products and the quality assurance in their industrial manufacture

Investigation with Pre-embryos
and Assisted Reproduction

  • Act 7/2003, of 20 October, regulating investigation in Andalusia with non-viable human pre-embryos for in vitro fertilisation
  • Act 45/2003, of 21 November, amending Act 35/1988, of 22 November, on Assisted Reproduction Techniques
  • Decree 364/2003 of 22 December, regulating the organisation, composition and operation of the Committee for Research with Human Pre-embryos and the authorisation procedure for research projects and centres with pre-embryos remaining from IVF techniques.
  • Act 14/2006, of 22 December, regulating the organisation, composition and operation of the Committee for Research with Human Pre-embryos and the authorisation process for research projects and centres with pre-embryos remaining from IVF techniques.
  • Act 29/2006, of 26 July, on guarantees and rational use of medicinal and healthcare products.
  • Act of Andalusia 1/2007, of 16 March, regulating investigation in cellular reprogramming exclusively for therapeutic purposes.

Regulation of Pharmaceutical Products

Eu Legislation-Eudralex

The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication "The rules governing medicinal products in the European Union".

The basic legislation is supported by a series of guidelines that are also published in the following volumes of "The rules governing medicinal products in the European Union":

Biobanks

  • Royal Decree 1716/2011 of 18 November, establishing the basic requirements for the authorisation and operation of biobanks for biomedical research purposes and the handling of human samples, and regulating the operation and organisation of the National Register of Biobanks for biomedical research.