Preclinical and Clinical Trial Requirements
The legal framework for preclinical and clinical trial requirements in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
The Health Law No 18-11, dated of 2 July 2018, replacing Health Protection and Promotion Law No 85-05, dated of 16 February 1985, and that constitutes the regulatory framework for clinical trials, does not expressly provide such requirement in view of obtaining the market authorization.
Nevertheless, clinical trials are subject to the prior authorization of the Ministry of Health granted within a period of three (3) months after initial submission, on the basis of a medical and technical dossier, and a declaration of intent to engage a clinical trial on humans to be filed by the sponsor. Any modification in the clinical trials dossier, once the authorization granted, is subject to the agreement of the Ministry of Health.
Anyone who contravenes the requirements related to clinical trials authorization is punishable by imprisonment of two (2) years to five (5) years, and a fine of 5.000.000 DZD to 10.000.000 DZD (approx. 41.750 to 83.500 USD).
2. How are clinical trials funded?
According to Article 384 of Health Law No 18-11, clinical trials must be conducted by a sponsor defined as the natural or legal person who initiates the clinical trial. It may be a pharmaceutical company, a contract research organization (CRO) approved by the Ministry of Health, a healthcare structure, a scientific society, a research institution or a natural person with the required qualifications and skills.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
According to the requirements stated in the Ministerial Decree No 388 dated of 31 July 2006, published in the Ministry of Health Bulletin, and related to clinical trials authorization process, the sponsor of a clinical trial must submit a written protocol, signed by the investigating physician(s) after he (they) has (have) expressed his (their) agreement, signifying his (their) acceptance of the protocol and his (their) commitment to respect the conditions of realization,
Clinical trials protocols must also be approved by the Medical Ethics Committee which is an independent body created at the level of the external healthcare services, and whose activities are supervised by the relevant departments of the Ministry of Health (“DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé” that will be gradually replaced by the “ANPP” – “Agence Nationale des Produits Pharmaceutiques”).
In addition, the clinical trials must be carried out in accordance with the rules of good practices in this area in approved and authorized structures, according to the requirements of the Ministerial Decree No 200 dated of 25 July 2009, published in the Ministry of Health Bulletin, and related to clinical trials good practices.
4. What are the requirements for consent by participants in clinical trials?
Clinical trials cannot be carried out in Algeria without the free, informed, and written consent of the persons to be included in the trial or their legal representatives. Prior information must be provided by the investigating physician or the physician who represents him, especially on:
- Duration of the trial;
- Expected benefits;
- Foreseeable risks;
- Possible medical alternatives;
- Right to refuse to participate in trial or withdraw consent at any time without incurring any liability and without prejudice to therapeutic care.
The consent of the participant in a clinical trial must be included in the study protocol. The consent of the person applies strictly and only to the trial for which he is asked, and no one can lend himself simultaneously to several clinical trials.
Any sponsor, who carried out a clinical trial without obtaining the consent of a participant in the clinical trial protocol, will be punished by imprisonment of two (2) years to five (5) years, and a fine of 100.000 DZD to 500.000 DZD (approx. 835 to 4.175 USD).
5. May participants in clinical trials be compensated?
Clinical trials, with the exception of those without direct individual benefit, do not give rise to any direct or indirect financial compensation for the persons who lend themselves to it, except the reimbursement of expenses incurred by these persons.
In the case of a clinical trial without direct individual benefit, the sponsor may pay the persons who lend themselves an indemnity compensation for the constraints.
However, clinical trials without direct individual benefit must not involve any foreseeable serious risk to the health of participants. They must be preceded by a medical examination of the persons concerned, and the results of this examination are communicated to them prior to the expression of their consent.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The sponsor is legally responsible for ongoing evaluation of the investigational drug safety, and must immediately notify any serious or unexpected adverse reaction, or any new safety fact, occurring during or after the end of the clinical trial, to the Ministry of Health, the Medical Ethics Committee for the clinical trial(s) concerned, and to all investigating physicians, at the latest, within seven (7) days.
There is also a requirement for the establishment of written, standardized operating procedures (SOPs) by the sponsor to meet the quality standards required for each stage of data collection, case documentation events and adverse effects, their validation, evaluation, archiving and reporting, as well as the guarantee of data protection. The sponsor must submit an annual safety report to the Ministry of Health and the Medical Ethics Committee for clinical trials.
For all interventional clinical trials, the sponsor must take out insurance covering his civil and professional liability for the activity he undertakes, whereas for those without direct individual benefit, the sponsor assumes, in all cases, even without fault, compensation for the trial harmful consequences for the person who lends itself to it and that of his successors.