Regulatory reforms in Algerian Pharma – a comprehensive legal overview. 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 there proposals for reform or significant change to the healthcare system?
Yes, there is an important reform that is ongoing and which concerns the authority in charge of regulating drugs, biologicals and medical devices for human use at the level of the Ministry of Health, Population and Hospital Reform (“MSPRH” – “Ministère de la Santé, de la Population et de la Réforme Hospitalière”).
According to provisions of Article 223 within the Health Law No. 18-11 dat- ed of 2 July 2018, a National Agency for Pharmaceutical Products (“ANPP” – “Agence Nationale des Produits Pharmaceutiques”) is established. It possesses a specific public institution status, with legal personality and financial autonomy, and is placed under the administrative authority of the Minister of Health.
ANPP ensures public service missions in the matter of:
- Evaluation of the benefits, risks and therapeutic value of drugs, biologicals and medical devices and their medico-economic assessment;
- Authorization of drugs and biologicals by granting of a registration decision, its renewal, and where appropriate, its suspension, withdrawal, or transfer, after the positive opinion of the Pharmaceutical Products Registration Commission;
- Authorization of medical devices by granting a homologation decision, its renewal, and where appropriate, its suspension, withdrawal, or transfer, following the positive opinion of the Medical Devices Homologation Commission;
- Issuance of an opinion on temporary use authorizations (ATU) for non-registered products;
- Definition of the rules of good practices of manufacture, storage, distribution and dispensing of pharmaceutical products;
- Carrying out on-site audits and inspections, in particular on the monitoring of compliance with the rules of good pharmaceutical practices and medical devices standards;
- Quality control of drugs, biologicals and medical devices, as well as the maintenance of standard substances and reference products at the national level;
- Specific control of substances and drugs with narcotic and/or psychotropic properties;
- Taking the necessary measures to safeguard public health when a drug or a medical device is, or is suspected, to present a danger to human health;
- Issuance of prior authorizations for the scientific information, promotion and advertising of authorized pharmaceutical products to health professionals;
- Issuance of an opinion on the standards, rules of good practice, procedures and methods applicable to clinical studies on drugs, biologicals and medical devices;
- Issuance of the price certificates of drugs and medical devices, after fixation by the Pharmaceutical Products Pricing Committee;
- Participation in drawing up the list of reimbursable medicines by Pharmaceutical Products Reimbursement Committee;
- Participation in the drafting of legislative and regulatory texts governing the drugs, biologicals and medical devices;
- Participation in international cooperation actions, in accordance with the legislation and the current regulations;
- Undertaking any study, research, training or information action in the fields of its competence and to contribute to the promotion of scientific research in the field of pharmaceutical products;
- Contribution to the establishment of updated nomenclatures, the development of the lists of essential drugs and medical devices, the national formulary and the national pharmacopoeia;
- Contribution to strategic plan for the development of national pharmaceutical sector.
The financial resources of the ANPP come in particular from:
- Subsidies included in the Government budget;
- Revenues related to the activity of the agency, including fees paid by pharmaceutical companies for the registration, homologation and advertising of drugs and medical devices;
- Income from the services provided;
- Donations and legacies;
- Any other income related to its activity.
Structures in charge of the missions devolved to ANPP under provisions of the Health Law No 18-11, including the General Directorate of Pharmacy and Health Equipment (“DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé”) and the Pharmaceutical Products National Control Laboratory (“LNCPP” – “Laboratoire National de Contrôle des Produits Pharmaceutiques”) continue to assume these missions until the full establishment of the Agency.
2. When are they likely to come into force?
Ongoing regulatory reform related to the establishment of the ANPP is likely to enter in application during the 2020-2021 biennium. The transfer process is gradual and follows a stepwise approach.
The Decree No 19-190 dated of 3 July 2019, setting out missions, organization and operating of the National Agency for Pharmaceutical Products (ANPP), has been published in the Official Gazette No 43 dated of 7 July 2019.
The headquarters of the ANPP was set in Algiers, while regional annexes of the agency may be created by order of the Minister of Health. Furthermore, activities related to products assessment, registration of drugs, and homologation of medical devices, have already been transferred from DGPES to ANPP.
The LNCPP was dissolved and all its building, laboratories, means, personnel and rights will be transferred to the ANPP. This transfer operation must be carried out, at the latest, within one (1) year from the date of publication of the Decree No 19-190 in the Official Gazette.
In addition, important legislative texts are under way and should be released during the 2020-2021 biennium. This covers specific regulations that the ANPP is working on in relation with OTC products and Similar Biotherapeutic Products, whose legal anchorages have been introduced as part of the Health Law No. 18-11 dated of 2 July 2018.
At the same time, there is deadline fixed to, at the latest, two (2) years from the date of publication of the Health Law No 18-11 in the Official Gazette, to update the pharmaceutical regulations through the revision of existing legislative texts (detailed in the answer to question 1 of “Regulatory, Pricing, and Reimbursement Overview”).