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Legislative index

• State and autonomic legislation
  • Organisation of the Health Service
  • Medicines
  • Data protection
  • Patient autonomy
  • Pregnancy termination
  • State legislation on organ transplants
  • State legislation on assisted reproduction
  • Legislation on research
  • Clinical tests
  • Clinical tests with healthcare products
  • State legislation on genetically modified organisms
  • Consumers
  • Equality
  • Domestic violence
  • Dependence
• Council of Europe
• European Union
• UNESCO
• Others

State and autonomic legislation

• Spanish Constitution, 29th December 1978

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Organisation of the Health Service

• Law 14/1986, of April 25th, General Health (BOE, 102, of June 29th). The sections 5, 6, 8, 9 and 11 of Article 10, section 4 of Article 11 and Article 61 of the Law 14/1986 General Health were replaced by the Law 41/2002 of November 14th, the regulating basis for patient autonomy and his/her rights and obligations with respect to clinical information and documentation
• Law 16/2003, of May 28th, on the cohesion and quality of the National Health Service (BOE 128, of May 29th)
  • Royal Decree 702/1998, of April 24th, on the organisation of the Territorial Services of the National Health Institute and the modification of the composition of the participating bodies in management control and monitoring (BOE 107, of May 5th 1998)
    • Order SCO/2024/2003, of July 15th, through which the composition and structure of operation of the Health Advisory Board is developed (BOE 172, of July 19th 2003)

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Medicines

• Law 29/2006, of July 26th, on the guarantees and rational use of medicines and healthcare products (BOE 178, of July 26th)
  • RD 1338/2006, of November 21st, through which particular aspects of article 93 of the Law 29/2006, of July 26th, on the guarantees and rational use of medicines and healthcare products are developed
  • Royal Decree 1344/2007, of October 11th, which regulates the pharmacovigilance of medicines for human use
  • Royal Decree 1345/2007, through which the procedure for the authorisation, registration and conditions of dispensation of industrially manufactured medicines for human use are regulated
  • Royal Decree 1246/2008, of July 18th, through which the procedure for the authorisation, registration and pharmacovigilance of industrially manufactured veterinary medicines is regulated (BOE 193, of August 11th 2008)
  • Royal Decree 1015/2009, of june 19th, regulating the availability of medicines in special situations
• Law 28/2009 of 30 December, to amend the Law 29/2006 of 26 July, on guarantees and rational use of medicines and medical devices (BOE December 31, 2009)

• Other legislation on medicines

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Data protection

• Organic Law 15/1999, of December 13th, on personal data protection (BOE of December 14th 1999)
  • Royal Decree 1720/2007, of December 21st, through which the Regulations for the development of Organic Law 15/1999, of December 13th, on personal data protection are approved

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Patient autonomy

• Law 41/2002, of November 14th, regulatory basis for patient autonomy, rights and obligations with respect to clinical information and documentation (BOE of November 15th 2002)

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Pregnancy termination

• ORGANIC LAW 10/1995, of November 23rd, on the Penal Code (article 144 onwards)
• Organic Law 2/2010, of march 3th, on Sexual and Reproductive Health and the voluntary interruption of pregnancy (BOE march 4 2010)
• Royal Decree 2409/1986, of November 21st, on authorised Centres and preceptive rulings for the legal practice of voluntary pregnancy termination
• Royal Decree 825/2010 of June 25th, on partial developments of the Organic Law 2/2010, of march 3th, on Sexual and Reproductive Health and the voluntary interruption of pregnancy
• Royal Decree 831/2010 of June 25th, on assurance of providing quality care to voluntary interruption of pregnancy

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State legislation on organ transplants

• Law 30/1979, of October 27th, on organ extraction and transplant
  • Royal Decree 2070/1999, of December 30th, which regulates the obtaining and clinical use of human organs and territorial coordination with respect to the donation and transplant of organs and tissue (BOE, January 3rd and 4th 2000)
  • Royal Decree 176/2004, of January 30th, through which the Statutes of the National transplant and Regenerative Medicine Centre were approved (BOE, January 31st 2004)
  • Others

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State legislation on assisted reproduction

• Law 14/2006, of May 26th, on Techniques of Assisted Reproduction (BOE, 282, of November 24th and, error correction, BOE 284, of November 26th)
• Royal Degree 42/2010, of 15th January, for that which regulates the National Commission on Human Assisted Reproduction (BOE 4 of February 2010)
• Organic Law 10/1995, of November 23rd, of the Penal Code (arts. 159 a 162)

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Legislation on research

• Law 14/2011, of June 1st, on Science, Technology & Innovation
• Law 14/2007, of July 3rd, on biomedical research (BOE, July 4th 2007)
• Royal Decree 1527/2010 of November 15th, by regulating the Guarantee Commission for the Donation and Use of Human Cells and Tissues and the Register of Research Projects.

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Clinical tests

• ROYAL DECREE 223/2004, of February 6th, regulating clinical tests with medicines
  • ORDER SCO/256/2007, of February 5th, establishing the principles and detailed directives for good clinical practice and the requirements to authorise the manufacture or importation of medicines for research on human use (BOE 38, of February 13th)
  • ORDER SCO/362/2008, of February 4th, modifying ORDER SCO/256/2007, of February 5th, to establish the principles and detailed directives for good clinical practice and the requirements to authorise the manufacture or importation of medicines for research on human use (BOE 41, of February 16th)

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Clinical tests with healthcare products

• Royal Decree 1591/2009, of October 16th, regulating health products (BOE of November 6th 2009)
• Royal Decree 1616/2009, of October 26th on active implantable health products (BOE of November 6th 2009)
• Royal Decree 223/2004, of February 6th (BOE of February 7th 2004), regulating clinical tests with medicines
  • Circular 7/2004, of clinical research with health products

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State legislation on genetically modified organisms

• Law 9/2003, of April 25th, establishing the legal regime for the confined use, voluntary liberation and commercialization of genetically modified organisms (which replaced the Law 15/1994, of June 3rd, establishing the legal regime for the confined use, voluntary liberation and commercialization of genetically modified organisms, in order to prevent risks to both human health and the environment), BOE, 100, of April 26th 2003
  • Royal Decree 178/2004, of January 30th, which approved the General Regulations for the development and execution of the Law 9/2003, of April 25th, establishing the legal regime for the confined use, voluntary liberation and commercialization of genetically modified organisms (BOE, 27, of January 31st 2004; Correction of errors, BOE 42, of February 18th)
    • Correction of errors of the Royal Decree 178/2004, of January 30th, which approved the General Regulations for the development and execution of the Law 9/2003, of April 25th, establishing the legal regime for the confined use, voluntary liberation and commercialization of genetically modified organisms (BOE, of February 18th 2004)

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Especially vulnerable subjects

• DECREE 49/2009, of March 3rd, to protect under age persons undergoing cosmetic surgery interventions in Andalucía

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Consumers

• Legislative Royal Decree 1/2007, of November 16th, which approved the rewritten text of the General Law for the Defence of Consumers and Users and other complementary laws
• Law 44/2006, of December 29th, improving consumer and user protection
• Law 39/2002, of October 28th, transposing several EU directives concerning the protection of consumer and user interests to the Spanish legal code (BOE num. 259, of October 28th 2002, pp. 37922-37933)
• Law 29/2009 of 30 December, by which is atended the law relating to unfair competition and publicity to improve consumer protection and users (BOE December 31, 2009)

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Equality

• Organic Law 3/2007, of March 22nd, for equality between men and women

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Domestic violence

• Organic Law 1/2004, of December 28th, on Comprenhensive Measures of Protection against Domestic Violence

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Dependence

• Law 39/2006, of December 14th, to Promote Personal Autonomy and Attention for persons in a situation of dependence (BOE 299, of December 15th)

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Council of Europe

• Convention on Human Rights and Biomedicine, of April 4th 1997 (Instrument of ratification, of July 23rd 1999) Convention of Oviedo
• Protocol for the Convention on Human Rights and Biomedicine to prohibit the cloning of human beings of April 4th 1997 (Ratified by Spain)
• Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin, January 24th 2002 (not ratified by Spain)
• Additional Protocol to the Convention on Human Rights and Biomedicine, concerning biomedical research, of June 30th 2004 (not ratified by Spain)
• Available in English or French at: www.coe.int

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European Union

• Charter of Fundamental Rights of the European Union of 2000 (Text included in its entirety in Part II of the European Constitution Project)
• Directive 2006/171CE of the Commission, of February 8th 2006, applying Directive 2004/23/CE of the European Parliament and the Council concerning certain technical requirements for the donation, obtaining and evaluation of human cells and tissues

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UNESCO

• Universal declaration on the Genome and Human Rights (1997)
• International Declaration on Human Gebetic Data (2003)
• Universal Declaration on Bioethics and human Rights (2005)
• Available in Spanish at: www.portal.unesco.org (Social & Human Sciences - Ethics - Bioethics)

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Others

• Declaration of Helsinki

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