Regulatory, Pricing and Reimbursement Overview
An insight into regulatory, pricing and reimbursement 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
Ministry of Health, Population and Hospital Reform (“MSPRH” – “Ministère de la Santé, de la Population et de la Réforme Hospitalière”) is the national regulatory authority responsible for drugs, biologicals, and medical devices for human use in Algeria.
General Directorate of Pharmacy and Health Equipment (“DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé”) at MSPRH is the body responsible for reviewing, assessing, regulating and monitoring pharmaceutical products, since the MSPRH’s new organizational chart implementation in 2012.
National Agency for Pharmaceutical Products (“ANPP” – “Agence Nationale des Produits Pharmaceutiques”, a financially independent institution newly created under Article 223 of Health Law No 18-11, dated of 2 July 2018, will gradually replace DGPES upon its establishment. ANPP will remain under the administrative authority of MSPRH.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
Health Law No 18-11, dated of 2 July 2018, published in the Official Gazette, replacing Health Protection and Promotion Law No 85-05, dated of 16 February 1985, forms the legislative framework for all activities related to drugs, biologicals and medical devices.
- Decree No 92-284 dated of 6 July 1992, published in the Official Gazette, related to registration of pharmaceutical products for human use;
- Decree No 93-114 dated of 12 May 1993, published in the Official Gazette, modifying and completing Decree No 92-285 dated of 6 July 1992, related to authorization of pharmaceutical products manufacturing and distribution sites;
- Ministerial Decree No 116/MSP/MIN dated of 5 December 1996, published in the Ministry of Health Bulletin, fixing registration conditions for generics products;
- Ministerial Decree No 18/MSP/MIN dated 13 February 1997, published in the Ministry of Health Bulletin, fixing template of registration decision and certificate of free sale related to pharmaceutical products for human use;
- Ministerial Decree No 138/MSPRH/MIN dated of 18 October 2005, published in the Ministry of Health Bulletin, fixing timelines for assessment of registration applications related to pharmaceutical products for human use;
- Ministerial Decree No 139/MSPRH/MIN dated of 18 October 2005, published in the Ministry of Health Bulletin, fixing template of registration application forms and composition of submission dossiers;
- Ministerial Decree No 12/MSPRH/MIN dated of 16 April 2012, published in the Ministry of Health Bulletin, modifying and completing Ministerial Decree No 2479 dated of 6 November 2007, fixing homologation conditions for medical devices.
- Decree No 98-44 dated of 1 February 1998, published in the Official Gazette, fixing the caps margins applicable for production, packaging and distribution of pharmaceutical products for human use.
- Ministerial Decree No 66 dated of 11 July 2012 modified and completed, published in the Ministry of Health Bulletin, related to organization and running of the Pharmaceutical Products Pricing Committee.
- Interministerial Decree dated of 16 August 2003, published in the Official Gazette, creating and fixing missions, organization and running of the Pharmaceutical Products Reimbursement Committee.
- Ministerial Decree dated of 6 March 2008 modified and completed, published in the Official Gazette, fixing the positive list of reimbursed products by social security.
- Ministerial Decree dated of 6 March 2008 modified and completed, published in the Official Gazette, fixing reference tariffs for products reimbursement by social security.
3. What are the steps to obtaining authorization to develop, test, and market a product?
New drugs, biologicals and medical devices cannot be marketed unless they have been granted authorization by Ministry of Health (“registration decision” for drugs and biological, “homologation decision” for medical devices, according to article 230 of Health Law No 18-11, dated of 2 July 2018).
Applications for market authorization must be submitted to the Ministry of Health on a form specially prepared for that purpose (Form A: for generic products; Form B: for new drug products; Form D: for medical devices), accompanied by a submission dossier that includes:
- Certificate of Pharmaceutical Product issued by regulatory authorities of country of origin in the format recommended by the World Health Organization + copy of valid market authorization in country of origin (for imported products) and/or CE marking certificate (for medical devices);
- Attestation of different manufacturers and sites involved in the manufacturing, packaging, control and releasing of the product (including for Active Pharmaceutical Ingredient or API).
- Authenticated copy of GMP compliance certificate and manufacturing authorization for all sites involved in manufacturing of API(s) and finished product.
- Technical dossier in electronic format including manufacturing and quality control data, and where appropriate, non clinical and clinical data of the product + access letter to the Drug Master File restricted part;
- 05 samples of finished product (both for imported and locally-manufactured products), accompanied by original certificate of analysis + template of artworks intended to be used;
- Note for therapeutic and economic interest summarizing absolute and relative medical service, in addition to public health importance;
- FOB price attestation certified by Chamber of Commerce in country of origin (for imported products) / ex-factory price structure (for locally-manufactured products).
- Receipt of registration fees payment + change attestation (payment in convertible foreign currencies for imported products).
The authorization process generally involves:
- Preliminary examination (at the end of which, an application receipt is granted),
- Evaluation of application (including laboratory quality control tests),
- Approval or denial of application (on quality/safety/efficacy criteria + price negotiation),
- Granting of the market authorization + list price attestation.
A temporary authorization for use (“ATU” – “Autorisation Temporaire d’Utilisation”) may be exceptionally issued by Ministry of Health for non-registered products, when the latter are prescribed as part of the management of serious diseases in situations where there is no equivalent treatment in the national territory, and have proven their therapeutic benefit.
4. What are the approximate fees for each authorization?
The drugs, biologicals and medical devices authorization fees are fixed as part of Finance Law. Fees are payable by the person who makes the application or submit variations to initial market authorization, in local currency for locally-manufactured products, and in convertible foreign currencies for imported ones.
As at December 2019, the current authorization fees are:
- For each new application related to imported and non essential drug or biological: 1.000.000 DZD (approx. 8.350 USD);
- For each new application related to imported and essential drug or biological: 600.000 DZD (approx. 5.000 USD);
- For each new application related to locally-manufactured and non essential drug or biological: 150.000 DZD (approx. 1.250 USD);
- For each new application related to locally manufactured and essential drug or biological: 100.000 DZD (approx. 835 USD);
- For each new application related to imported medical device: 300.000 DZD (approx. 2.500 USD);
- For each new application related to locally-manufactured medical device: 150.000 DZD (approx. 1.250 USD);
- For each product assessed: 30.000 DZD (approx. 250 USD);
- For each API batch controlled in laboratory: 15.000 DZD (approx. 125 USD);
- For each finished product batch controlled in laboratory: 12.000 DZD (approx. 100 USD);
- For each market authorization renewal application: 300.000 DZD (approx. 2.500 USD);
- For each variation(s) to market authorization application: 150.000 DZD (approx. 1.250 USD).
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
The market authorization is issued for a period of five years, renewable every five years. It may also be amended, suspended or withdrawn by the Minister for Health under certain conditions.
The market authorization is renewable at the request of its holder. This request must be submitted no later than ninety (90) days before the expiry date of the validity of the said decision.
It is renewed only if the decision holder certifies that no change has occurred in the evidence submitted in support of the initial application for registration/ homologation, especially regarding indications, composition, contraindications, precautions for use and adverse effects. If necessary, additional justifications may be requested.
For imported products, a recent Certificate of Pharmaceutical Product issued by regulatory authorities of country of origin in the format recommended by the World Health Organization + copy of valid market authorization in country of origin and/or CE marking certificate (for medical devices), are required.
6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
Market authorization for generic products is subject to the same requirements as brand-name products, except that generic products are exempted from pharmacological, toxicological and clinical tests required for brand-name ones.
However, for products with a narrow therapeutic index, or with significant bioavailability problems or with particular pharmacokinetic characteristics, the Ministry of Health may request that the in vivo bioequivalence of the generic product, object of the application, be demonstrated against the brand-name product already on the market.
Excluding application submission dossier composition and currency of registration fees, there are no differences in regulatory requirements between locally manufactured products and imported ones, but in practice, and according to the government’s will to support local manufacturing and to promote investment (Article 206 of Health Law No 18-11, dated of 2 July 2018), assessment priority is given for locally manufactured products, including during pricing process (timelines of 5-6 months set in Ministerial Decree No 138/ MSPRH/MIN dated of 18 October 2005).
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
There are no specific regulations for combination products in Algeria, nor is this term used in legal provisions. In practice, if the main intended action of the combination product is achieved by the drug or biological (defined as drug by Article 210 of Health law No 18-11) or if they form a single integrated product with the medical device (e.g. pre-filled syringes and pens, patches for transdermal drug delivery and pre-filled inhalers), the entire product is regulated as a drug under provisions of Health Law No 18-11, dated of 2 July 2018 and other applicable drugs regulations.
Whereas, if the main action is achieved by the medical device (defined by Article 212 of Health law No 18-11, that mentioned possibility of being “used alone or in combination”), then medical devices regulations are applicable.
If drug/biologicals and medical devices are co-packaged (separate items contained in the same package) or obtained separately (independent manufacturing and control processes), relevant regulations for each item are applicable.
8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
Compliance of authorized products on the market, and the activities carried out by manufacturers, importers, exporters, and distributors with regulations, is monitored and evaluated by Ministry of Health, at which “ANPP” – “Agence Nationale des Produits Pharmaceutiques”, a financially independent institution newly created by Article 223 of Health Law No 18-11, dated of 2 July 2018, will gradually replace “DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé”, upon its establishment.
Ministry of Health ensures the supervision and enforcement of the legal provisions through periodical inspections conducted by Ministry of Health inspectors at the authorized structures premises (Article 191 of Health Law No 18-11), quality and risk assessments on the authorized products, as well as audit and report- ing requirements, including adverse events under pharmacovigilance rules.
9. What is the potential range of penalties for noncompliance?
According Health Law No 18-11 provisions, any manufacturing, operating, import, export or distribution of pharmaceutical products by structures not approved by the competent services, is punishable by imprisonment of five (5) years to ten (10) years and a fine of 5.000.000 DZD to 10.000.000 DZD (41.750 to 83.500 USD).
Anyone who contravenes the prohibition related to the manufacture, brokerage, distribution, advertisement, offer for sale, sale, import, export or possession of falsified drugs (defined in Article 211 of the Health Law No 18-11) is punishable by imprisonment of five (5) years to ten (10) years and a fine of 1.000.000 DZD to 5.000.000 DZD (8.350 to 41.750 USD).
Every person who contravenes the provisions related to registration of pharmaceutical products and homologation of medical devices, will be punished by imprisonment of two (2) years to five (5) years, and a fine of 1.000.000 DZD to 5.000.000 DZD (8.350 to 41.750 USD).
10. Is there a national healthcare system? If so, how is it administered and funded?
Algeria has a national healthcare system characterized by near-universal coverage and free-of-charge treatment at the point of delivery. The Government provides funding for the public health sector, in accordance with the legislation and regulations in force, for the prevention, training, medical research, healthcare, in benefit of poor people and for those in difficulty.
Public expenditure on healthcare accounted for 70% of total health expenditure in 2018 (public hospitals budgets, social security, national health insurance and local collectives), and is expected to remain relatively stable over the next few years.
The Government ensures the financial equilibrium of the public sector in order to meet the national needs. The resources mobilized for funding the national healthcare system and the expenditures made on it have to be published annually in the form of accounts called “National Health Accounts”.
11. How does the government (or public) healthcare system function with private sector healthcare?
Organization of the national healthcare system is based in particular on:
- Health map and health organization plan;
- External structures of the health sector;
- Health public service provided by public and private institutions invested with this mission;
- Private health sector;
- Intersectorality in the implementation of the national health policy;
- Complementarity between the public and private sectors in health services;
- Diagnostic and therapeutic approaches based on factual consensus, regularly updated;
- Organization and promotion of training and research in the health sciences;
- Contribution of the associative and mutualist movement;
- Healthcare networks.
Creation of private health structures and institutions must meet the standards defined by the health map and the priorities set by the health organization plan. They have also to meet the technical installation and operating conditions set by Ministry of Health.
Expenditures on healthcare provided by private health structures and institutions with health public service missions are governed by agreements with the Ministry of Health. In all cases, they must comply with the regulations on public information and pricing inherent to the healthcare activity.
12. Are prices of drugs and devices regulated and, if so, how?
Prices of drugs and devices are regulated by the Pharmaceutical Products Pricing Committee established at Ministry of Health by Ministerial Decree No 66 dated of 11 July 2012 modified and completed, published in the Ministry of Health Bulletin.
The Pricing Committee is an interministerial committee chaired by Ministry of Health, Population and Hospital Reform (“MSPRH” – “Ministère de la Santé, de la Population et de la Réforme Hospitalière”).
Different governmental departments are represented within the Pricing Committee:
- Ministry of Labor, Employment & Social Security (responsible of reimbursement).
- Ministry of Finance (through Customs and Taxes Directorate representatives, since 2015).
- Ministry of Commerce (since 2015).
- Ministry of Industry (since 2015).
a) For locally-manufactured products:
Prices are fixed in local currency (ex-factory) by the Pricing Committee. Legal margins for wholesalers, and pharmacists (if the product is dispensed through private community pharmacies), should be added to calculate the public price (all authorized medicines are value added-tax free).
b) For imported products:
Prices are fixed in foreign currency (FOB incoterm, mainly in EUR) by the Pricing Committee. Prices are converted in local currency per each importation operation, transportation and insurance fees are added. Then, legal margins for wholesalers, and pharmacists (if the product is dispensed through private community pharmacies), should be added to calculate the public price (all authorized medicines are value added-tax free).
A new product cannot be launched on the market without prior agreement on price. List price attestation is granted by Ministry of Health at the same time as the market authorization.
There is a provision for the appeals within the Pricing Committee organizing Ministerial Decree No 66 dated of 11 July 2012. The timeline to introduce an appeal has now been fixed to 30 days from notification of the Committee initial decision, and final decision of the committee after appeal is irrevocable.
13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?
Government is fully covering costs for all products dispensed through public hospital pharmacies, in addition to mandatory vaccines offered free of charge at vaccination centers.
National health insurance (social security) is covering the costs of drugs and medical devices on the reimbursement positive list fixed and updated by the Reimbursement Committee established under Interministerial Decree dated of 16 August 2003, published in the Official Gazette.
Social security is covering 100% of costs for reimbursed products related to a fixed list of serious chronic diseases and/or in benefit of poor people and those in difficulty, and 80% of costs for other reimbursed products in profit of affiliated patients (about 90% of population), on the basis of the list prices, or the reference tariffs when they have been established by the Reimbursement Committee.
Private health insurance companies exist under the Health Law No 18-11 provisions. They are taken by patients themselves or their employers to cover the remaining 20% of costs for reimbursed products covered at 80% rate by social security, and costs of non reimbursed products.
Finally, patients without private health insurance pay out of their pocket for non reimbursed products and those directly purchased from private community pharmacies through self-medication (without physician prescription).
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
Drugs and medical devices are dispensed to patients by pharmacists at both hospital pharmacies and private community pharmacies. They have to dispense pharmaceutical products only on a physician prescription. However, community pharmacists may dispense without a medical prescription certain products whose list is fixed by the Minister of Health.
According to the Health Law No 18-11 provisions, pharmacists dispensing drugs and medical devices at hospitals (public and private ones) benefit from a special status and a compensatory regime, generally a fixed salary, in line with the specificities of the sector, whereas pharmacists who dispense pharmaceutical products at private community pharmacies are compensated differently.
In Algeria, the pharmacist is the sole owner and manager of the community pharmacy he holds. Decree No 98-44 dated of 1 February 1998, published in the Official Gazette, allows a degressive capped retail margin depending of the product CAF price (for imported products) or ex-factory price (for locally-manufactured products):
- 50% of wholesale price for products priced up to 70 DZD/box (0,60 USD/box);
- 33% of wholesale price for products priced between 70-110 DZD/box (0,60-0,90 USD/box);
- 25% of wholesale price for products priced between 110-150 DZD/box (0,90-1,25 USD/box);
- 20% of wholesale price for products priced more than 150 DZD/box (1,25 USD/box).
In addition, a fixed remuneration valued between 1,50-2,50 DZD (0,012-0,020 USD) for each box dispensed is allowed and integrated in the final public price. Pharmacists other than the holder and recruited for dispensing drugs and med- ical devices at community pharmacies perceive a fixed salary.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
Hospital pharmacists are responsible for:
- Ensuring management, supply, preparation, control, storage, detention and dispensation of drugs and medical devices used by the hospital;
- Conducting or participating in information campaign on drugs and medical devices, in actions aiming to promote their good use and contributing to their evaluation;
- Conducting or participating in actions likely to contribute to the quality and safety of the treatments and care;
- Applying rules of hospital pharmacy good practices set by Ministry of Health.
Community pharmacists are responsible for:
- Ensuring retail dispensation of drugs and medical devices after verifying prescriptions;
- Executing of magistral and officinal preparations;
- Providing health-related services, participating in information, counseling, follow-up and therapeutic education for patients, and encouraging the use of generic products;
- Calling without delay (under pain of the penalties) to the intervention of a physician when, during the exercise of their activities, they detect any risk for patient in relation with the expected treatments.
According to the Health Law No 18-11 provisions, any discharge, storage, display or dispensing of drugs or medical devices on the public area or in other places not authorized by Ministry of Health, carried out by any person even with a pharmacist degree, is considered an illegal practice of the pharmacist profession, and is punishable in accordance with Article 243 of Penal Code.
Under pain of the penalties, it is forbidden for any pharmacist dispensing drugs or medical devices to solicit or to accept directly, or through an intermediary, in the course of his duties, gifts, gratuities or any benefits of any kind.
Except for justified medical necessity, any pharmacist who, through negligence or proven professional misconduct in the exercise or on the occasion of his duties affects the physical integrity or health of a person causing permanent disability, endangering his life or causing his death, is punishable in accordance with Articles 288, 289 and 442 of Penal Code.
Failure to comply with the obligation of medical and professional secrecy exposes the pharmacist to the penalties provided for in Article 301 of Penal Code.