LEGAL OPINION 1.

SOURCE OF LAW:
REGULATION (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency states: “Whereas ... (33) ... In order to meet,in particular,the legitimate expectations of patients and to take account of the increasingly rapid progress of science and therapies, accelerated assessment procedures should be set up, reserved for medicinal products of major therapeutic interest,and procedures for obtaining temporary authorisations subject to certain annually reviewable conditions. In the field of medicinal products for human use, a common approach should also be followed, whenever possible, regarding the criteria and conditions for the compassionate use of new medicinal products under Member States' legislation.”

If you take a look at MEMO/01/267 on the Reform of EU Pharmaceutical Legislation proposed to include that “Regarding compassionate use of medicinal products for human use, the EMEA shall be able to adopt recommendations, establishing the conditions for this compassionate use to be put into practice, to be applied by Member States.”

Particularly, if you read Article 83 (EC) No 726/2004, it states that “1.By way of exemption from Article 6 of Directive 2001/83/EC Member States may make a medicinal product for human use belonging to the categories referred to in Article 3(1)and (2)of this Regulation available for compassionate use. 4.When compassionate use is envisaged, the Committee for Medicinal Products for Human Use, after consulting the manufacturer or the applicant, may adopt opinions on the conditions for use,the conditions for distribution and the patients targeted.The opinions shall be updated on a regular basis. 7.The opinions referred to in paragraph 4 shall not affect the civil or criminal liability of the manufacturer or of the applicant for marketing authorisation.

In addition, DIRECTIVE 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use, states in its Article 5: “A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorized health care professional and for use by his individual patients on his direct personal responsibility.”

REFERENCES:
http://pharmacos.eudra.org/F2/eudralex/vol-1/REG_2004_726/REG_2004_726_EN.pdf
http://pharmacos.eudra.org/F2/eudralex/vol-1/DIR_2001_83/DIR_2001_83_EN.pdf
http://pharmacos.eudra.org/F2/review/doc/brief_m01_267_en.pdf

LEGAL OPINION 2

SOURCE OF LAW:
DIRECTIVE 2001/20/EC of the European Parliament and of the Council of 4 april 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, simply does not mention the compassionate use treatment.
If you pay attention to what is stated in this Directive, you will see that authorisations, import permits and compliance with good clinical and manufacturing practice is a responsibility of member states.

If you take a look at Article 9.2, it states that “Before commencing any clinical trial,the sponsor shall be required to submit a valid request for authorisation to the competent authority of the Member State in which the sponsor plans to conduct the clinical trial”.
Article 13, when regulating the manufacture and import of investigational medicinal products, declares that “Member States shall take all appropriate measures to ensure that the manufacture or importation of investigational medicinal products is subject to the holding of authorisation”.
Article 15 says that “To verify compliance with the provisions on good clinical and manufacturing practice, Member States shall appoint inspectors to inspect the sites concerned by any clinical trial”
Directive 2001/20/EC was transposed into Spanish law by ROYAL DECREE 223/2004 of 6 February,which regulates clinical trials involving medicines.
Artícle 32 of ROYAL DECREE 223/2004 when regulating the import of medicinal products in investigation states that “The import of a medicinal product in investigation to be administered in a clinical trial, only will be possible previous authorisation from the “Agencia Española del Medicamento y Productos Sanitarios” (La importación de medicamentos en investigación, para su utilización en el ámbito de un ensayo clínico, únicamente podrá realizarse previa autorización de la Agencia Española de Medicamentos y Productos Sanitarios).

REFERENCES:
http://pharmacos.eudra.org/F2/eudralex/vol-1/DIR_2001_20/DIR_2001_20_EN.pdf
http://www.apotransferrin.com/images/REAL%20DECRETO%20223_2004.pdf

LEGAL OPINION 3

It is stated about marketed medicinal products that “The granting of authorisation shall not affect the civil or criminal liability of the manufacturer or of the holder of the marketing authorisation pursuant to the applicable national law in Member States”. Article 15 of REGULATION (EC) No 726/2004.
Article 19 of DIRECTIVE 2001/20/EC, when it states general provisions on investigational medicinal products, it says that “This Directive is without prejudice to the civil and criminal liability of the sponsor or the investigator.To this end, the sponsor or a legal representative of the sponsor must be established in the Community”.

NEVERTHELESS THESE REGULATIONS ARE NOT APPLICABLE TO THESE CASES. WE ARE NOT TALKING ABOUT A MARKETED PRODUCT, AND NEITHER SPONSOR NOR INVESTIGATOR EXIST IN OUR CASE. WE ARE TALKING ABOUT A COMPASSIONATE USE TREATMENT, AND WE WILL HAVE TO EXAMINE WHAT IS STATED UNDER SPANISH LAW PROVISIONS.

ROYAL DECREE 223/2004 which transposes Directive 2001/20/EC into Spanish law, in its Artícle 1, when defining the scope of this law, states that “This Royal Decree applies to clinical trials on medicinal products for human use conducted in Spain. It is not a clinical trial the administration of a medicinal product in investigation for a single patient, according to good clinical practice and only aiming to the patient therapeutic benefit. This case will be regulated under the provisions of article 28 for the compassionate use treatments.(Este Real Decreto se aplicará a los ensayos clínicos con medicamentos de uso humano que se realicen en España. A estos efectos, no tendrá la consideración de ensayo clínico la administración de un medicamento en investigación a un solo paciente, en el ámbito de la práctica médica habitual y con el único propósito de conseguir un beneficio terapéutico para el paciente, que se regirá por lo dispuesto sobre uso compasivo en el artículo 28).
Artícle 28, defines Compassionate use of medicinal product. and it states that “There must be considered a compassionate use treatment the utilization of medicinal products in invetigation outside a clinica trial, being included in this definition the use of medicinal products prescribed in different manner in accordance with the terms of the marketing authorisation, when the medical doctor under his/her exclusive responsibility considers that its use is vital for the patient.( Se entiende por uso compasivo de medicamentos la utilización en pacientes aislados y al margen de un ensayo clínico de medicamentos en investigación, incluidas especialidades farmacéuticas para indicaciones o condiciones de uso distintas de las autorizadas, cuando el médico bajo su exclusiva responsabilidad considere indispensable su utilización).

The Spanish LAW 25/1990, of 20 december on Medicinal Products (Ley del Medicamento), in its Article 38.5 states that “Exceptionally, the Ministry of Health will be able to deliver authorisation for the use of medicinal products in investigation to patients not included in clinical trials when the medical doctor, under his/her exclusive responsibility, and always with the express consent of the patient, believes that the medicinal product in investigation is vital for the treatment. S/he will have to justify in front of the Health Authorities why this treatment has been decided” (Excepcionalmente, el Ministerio de Sanidad y Consumo podrá conceder autorización, con las condiciones que en ella se expresen, para la prescripción y la aplicación de medicamentos en investigación a pacientes no incluidos en un ensayo clínico, cuando el médico, bajo su exclusiva responsabilidad y con el consentimiento expreso del paciente, considere indispensable tratarles con ellos y justifique ante la autoridad sanitaria los motivos por los que decide tal tratamiento).

WE ALREADY GOT THIS AUTHORISATION FROM THE “AGENCIA ESPAÑOLA DEL MEDICAMENTO Y PRODUCTOS SANITARIOS” ON BEHALF OF THE SPANISH MINISTRY OF HEALTH.

In addition, the case of criminal or civil non-contractual liability, the “Agencia Española del Medicamento y Productos Sanitarios” shall, in accordance with the general principles common to the Spanish Public Law, make good any damage caused by it or by its servants in the performance of their duties.

REFERENCES:
http://noticias.juridicas.com/base_datos/Admin/l25-1990.html

CONCLUSION

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