Orphan Drugs & Rare Diseases
All legal aspects surrounding orphan drugs & rare diseases in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for USD 99.
1. What is the definition of Rare Diseases in your country?
In Egypt, there is no definition of the “Rare Diseases” however, in accordance with the conclusion of medicine professors’ researches and studies a disease is considered a rare disease if it affects 1 in 2,000 or 2,500 individuals.
2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)
Currently, there is no designation in Egypt for Orphan Drugs.
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?)
There is no specific regulation that regulates the orphan drugs in Egypt separately; the regulatory framework of drugs authorization of the Ministerial Decree No. 415 of the year 2015 will be applied to the orphan drugs.
4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?
No, up until now Egypt has not provided specific clinical requirements for orphan drugs; however, in accordance with the Egyptian Group for Orphan Renal Disease “EGORD”, they’ve referred that due to the rarity and diversity of rare diseases, research needs to be international to ensure that experts, researchers and clinicians are connected, that clinical trials are multinational and that patients can benefit from pooling of resources across borders.
5. Is there an expedited pathway for Orphan Drugs?
Until this day, there is no disclosure regarding the issuance of pathways of Orphan Drugs.
6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?
In Egypt, the Ministry of Health recognizes foreign marketing authorizations, which are issued by efficient foreign supervisory bodies such as the European Medicines Agency “EMA”, and the US Food and Drug administration “FDA”, the Japanese Ministry of Health, or the Australian Therapeutic Goods Administration, Labour and Welfare.
7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?
Until this day, there is no specific reimbursement policy considered for orphan drugs
8. How are the prices of Orphan Drugs regulated?
The prices of the orphan drugs are regulated through the same pricing mechanism of other drugs in Egypt, under the Ministerial Decrees No.314 of the year 1991, Decree No.373 of the year 2009 and Decree No. 499 of the year 2012. Egypt adopted pricing method of cost plus margin, which means that each company submits a study reflecting the cost for producing or importing pharmaceuticals into the market and automatically apply the applicable margin for each stakeholder in the supply chain up the customer price. After issuing Decree No. 373 of the year 2009, Egypt adopted a new pricing method based as it applies the least customer price available in any country where the pharmaceuticals is traded after applying a discount of 10%, the same margins for distributor and pharmacist remain applicable even after the issuance of this decree.
Under Decree No. 499 of the year 2012, the Decree aimed to increase the margins for distributors and pharmacists, while maintain the same pricing method with slight variations.
Mainly, the prices of the pharmaceuticals are determined during the registrations phase, the pricing committee in the Central Administration of Pharmaceutical Affairs CAPA is responsible for reviewing the pricing application and documents, the decision of the committee shall be endorsed by the Ministry of Health “MOH”.
9. In case of reference price based on a basket of countries, what countries are included?
The recommended price is approved or reduced according to the lowest price-referenced country for the referenced product. The reference countries are Australia, Austria, Belgium, Canada, Denmark, Germany, Finland, France, Iceland, Ireland, Netherlands, Japan, Luxemburg, U.S.A, New Zealand, Norway, Sweden, Switzerland, United Kingdom, Italy, Portugal, and Spain.
10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?
No, until now in Egypt, there are no significant legal developments related to the 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 are no proposals published stating any changes that may come into force.