Peru: Differentiated mechanisms for the procurement of drugs by the state under the Rare or Orphan Diseases Act

In brief

Within the framework of the publication of Law No. 31738 ("Law"), which amends several articles of Law No. 29698 (Law that declares of national interest and preferential attention the treatment of persons suffering from Rare or Orphan Diseases) and which we commented in our alert of May 12 (see here), we share an analysis of Article 6 of the Law, which establishes the possibility of using differentiated mechanisms for the acquisition and contracting of medicines and services for the treatment of rare or orphan diseases.


In depth

What are rare or orphan diseases?

  • Article 2, numeral 1 of Law No. 29698 defines Rare or Orphan Diseases as those that are life-threatening or chronically debilitating, have a low frequency, present many difficulties to be diagnosed and followed up, have an unknown origin in most cases, entail multiple social problems and have scarce epidemiological data.
  • The most common orphan diseases in the world are Noonan syndrome, congenital bilateral absence of vas deferens, cutaneous lupus erythematosus and hyperplastic polyposis syndrome, among others. Additionally, some examples of rare diseases are hereditary autism, Brugada syndrome, familial melanoma and Guillan-Barre syndrome, among others.

Mechanisms for the contracting of medicines and services to attend rare or orphan diseases by the state:

a. Entities empowered to contract:

  • Ministry of Health
  • Social Health Insurance (ESSALUD), within the framework of the corporate directive for business management issued by the National Fund for the Financing of the State's Entrepreneurial Activity (FONAFE).
  • Sanitation of the Peruvian Armed Forces and National Police

b. Subject matter of the procurement:

  • Pharmaceuticals, medical devices and health services that are necessary for the prevention, promotion, diagnosis, treatment, monitoring and rehabilitation of people suffering from rare or orphan diseases.

c. Procedure to carry out the acquisition:

  • The entities are authorized to use differentiated procurement mechanisms such as risk-sharing, price-volume, additional doses, fixed payment per patient, portfolio agreements and clinical objectives, among others, in accordance with the regulations in force on the matter.
  • The Law does not establish the parameters for the use of these differentiated acquisition mechanisms. Therefore, these may be developed in the amendments to the Regulations of Law No. 29698, in accordance with the provisions of the First Final Complementary Provision of the Law. As a reference, the Regulation of Law No. 31336, "National Cancer Law", regulates differentiated procurement mechanisms for pharmaceutical products and medical devices, such as financial and performance-based agreements.

Main Novelty of Law No. 31738

The aforementioned procurement and contracting mechanisms shall be exempted from the scope of application of Law No. 30225, State Contracting Law and its respective regulations.

We hope that this information will be of relevance to you and your company. If you require any further information, please do not hesitate to contact us.

Spanish version

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