Orphan Drugs and Rare Diseases
A brief overview of the situation regarding orphan drugs and rare diseases 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 is the definition of Rare Diseases in your country?
Rare diseases are defined in Algeria as those listed in the Ministerial Decree, dated of 6 February 2013 and published in the Official Gazette, fixing lists of rare diseases and life-threatening conditions as well as pharmaceutical products intended for their treatment.
Their number is of twenty-eight (28) rare diseases:
- Factor VII deficiency;
- Fibrinogen deficiency;
- Prothrombin deficiency;
- Growth Hormone deficiency;
- Dy tonia;
- Glanzmann disease;
- Fabry disease;
- Gaucher disease;
- Lobstein’s disease;
- Niemann Pick disease;
- Still disease;
- Willebrand disease;
- Wilson disease;
- Myasthenia gravis;
- Pump disease;
- Psoriatic arthritis;
- West syndrome;
- Sjogren syndrome;
- Antisynthesizing syndrome;
- Hereditary tyrosemia;
- Xeroderma pigmentosum.
2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)
According to Ministerial Decree No 35/MSP/MIN, dated of 6 April 1997 and published in the Ministry of Health Official Bulletin, related to marketing of orphan drugs, the latter are defined as all drugs necessary for public health whose manufacture is no longer provided by producers for profitability reasons or withdrawal of a therapeutic scheme, or for the treatment of rare diseases.
3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)
Despite its designation as orphan drug in the country (designation granted outside Algeria is not automatically taken into account), a product cannot be marketed unless it has been granted authorization by Ministry of Health according to Article 230 of Health Law No 18-11, dated of 2 July 2018. This requirement extends to treatments intended for rare diseases as listed in the Ministerial Decree, dated of 6 February 2013.
There are currently no specific regulations for the authorization of orphan drugs in Algeria. The regulatory framework for the authorization, pricing, and reimbursement remains the same as for the other drugs (see answer to question 2 of “Regulatory, Pricing, and Reimbursement Overview”).
4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?
No, there are no provisions for relaxed clinical trial/scientific evidence requirements for orphan drugs.
5. Is there an expedited pathway for Orphan Drugs?
Orphan drugs may be marketed under the regimen a temporary authorization for use (“ATU” – “Autorisation Temporaire d’Utilisation”) to be granted by the Minister of Health according to provisions of Article 233 of the Health Law No 18-11, when they have proven their therapeutic benefit. Manufacturers can apply for regular authorization by filling a complete application dossier in cases where prevalence and economic profitability thresholds are met.
6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?
No, there are no foreign marketing authorizations recognized in Algeria for orphan drugs, but a valid authorization and effective marketing in the country of origin is a mandatory regulatory requirement.
7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan Drugs?
The Algerian government is fully covering costs of orphan drugs as for all products dispensed free of charge through public hospital pharmacies.
8. How are the prices of Orphan Drugs regulated?
Prices of orphan drugs are regulated like other drugs 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 Official Bulletin (see answer to question 12 of “Regulatory, Pricing, and Reimbursement Overview”).
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.
Orphan drugs marketed under the regimen of a temporary authorization for use (“ATU” – “Autorisation Temporaire d’Utilisation”) have not a list price. Therefore, negotiation is directly conducted between the manufacturer and the Hospitals Central Pharmacy (“PCH” – “Pharmacie Centrale des Hôpitaux”), responsible for purchasing orphan drugs, in order to determine the transaction price.
9. In case of reference price based on a basket of countries, what countries are included?
The Pharmaceutical Products Pricing Committee is benchmarking the prices in 8 foreign countries (France, Belgium, United Kingdom, Spain, Morocco, Tunisia, Greece, and Turkey), in addition to country of origin if different, to determine the maximum list price in Algeria.
10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?
No, there has not been any significant legal development for orphan drugs.
11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?
No, there is no short term plan for regulatory reform in relation with orphan drugs in Algeria.