Orphan Drugs & Rare Diseases
Key legal info on orphan drugs & rare diseases in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for USD 99.
1. What is the definition of Rare Diseases in your country?
Rare Diseases are defined, by Supreme Decree No. 004-2019-SA, as those with danger of death or chronic disability, which have a frequency of less than 1 disease per 100,000 people. In some cases, they are difficult to detect and, in most cases, have an unknown origin which carry social problems and have little epidemiological data. They may include congenital malformations and diseases of genetic origin.
2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)
The designation does exist, and is defined as those that have demonstrated a favorable risk-benefit ratio in the prevention, diagnosis and/or treatment of rare and/or orphan diseases that have low or no pharmaceutical production, which results in limitations in their supply in the market.
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?)
The Ministry of Health, through a Ministerial Resolution, authorizes the use of medicines for rare or orphan diseases including them in the Single National Petition for Essential Medicines.
Medicines for rare and/or orphan diseases are subject to evaluation of sanitary technology, budget impact analysis and budged availability and intense pharmacovigilance.
Furthermore, pharmacotherapeutic following of the patients is realized in order to determine problems with the medicines.
4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?
There are no special provisions for clinical trials in respect with Orphan Drugs.
5. Is there an expedited pathway for Orphan Drugs?
There is not an expedited pathway for Orphan Drugs.
6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?
Foreign marketing authorizations are not recognized for Orphan Drugs.
7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?
There is not a process for the reimbursement of Orphan Drugs
8. How are the prices of Orphan Drugs regulated?
The prices of Orphan Drugs are not regulated; however, they are partially funded by the State.
9. In case of reference price based on a basket of countries, what countries are included?
10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?
Yes, on February 22 2019, the Regulation of Law No. 29698, Law declaring of National Interest and Preferential Attention the Treatment of Persons Suffering from Rare or Orphan Diseases, was published and came into effect.
The purpose of this Regulation is to establish technical and regulatory provisions for the implementation of Law No. 29698, Law that declares of national interest and preferential attention the treatment of people suffering from Rare or Orphan Diseases (ERH) which main purposes are the Diagnosis, Attention, Treatment, Rehabilitation and Monitoring of Rare and Orphan Diseases.
Furthermore, among other provisions, this Regulation aims to promote and finance investigations to discover new ways to treat such diseases.
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?
Since the Regulation has just came into effect there are no proposal to significantly change it.