Congress Approves Rare Disease Drug Bill
Peru Congress approves Bill to expedite Access to Rare Disease Medications
Lima, Peru – The Congress of the Republic of Peru has given its final approval to a bill aimed at streamlining access to medications and biological products for the treatment of rare diseases, cancers, and other complex conditions.
The legislative initiative is designed to ensure that Peruvian citizens have timely, equitable, and high-quality access to essential treatments, safeguarding their fundamental rights to health and life.
Lawmakers approved the measure, which establishes a series of procedures to accelerate the registration and re-registration of medications and biological products already approved in countries with stringent health surveillance standards. The bill addresses the pressing need for innovative and effective treatments for diseases that often lack adequate medical solutions.
Following the final vote in Congress, the Ministry of Health will be responsible for defining and updating the list of rare and orphan diseases within 30 calendar days of the law’s enactment. This provision ensures that the list remains current with medical and scientific advancements in the treatment of complex and uncommon pathologies.
The legislation aims to create a legal framework that facilitates access to medications and biological products already registered in countries with high health surveillance standards. This is a crucial step in treating rare and orphan diseases,which often lack therapeutic options in the local market. The law ensures that patients can receive effective, internationally recognized medicines without lengthy evaluation and authorization delays.
In addition to expediting the registration process, the bill includes the creation of an Accelerated Evaluation Procedure to reduce approval times, which is essential for patients requiring immediate treatment.
The bill also provides exemptions from certain requirements outlined in Law 29459, which regulates pharmaceutical products, medical devices, and health products. These products will not be subject to the same regulations as domestically produced items, further facilitating their accessibility.
Legislators emphasized that this aspect of the bill will enhance the speed of approval for medicines already validated by rigorous health systems in other countries, eliminating unnecessary bureaucratic delays.
Another key component of the initiative is the implementation of an Accelerated Evaluation Procedure, which sets a maximum approval period of 45 calendar days for medicines and biological products. If no response is received within this timeframe, the law introduces a “positive Administrative Silence” mechanism, meaning the product is automatically approved unless objections are raised within the specified period.
Products seeking registration must possess a Pharmaceutical Product Certificate or a Free Marketing Certificate, demonstrating that the medicine is authorized and marketed in countries with high health surveillance standards. This requirement ensures the authenticity and quality of the products through rigorous international quality controls.
During the legislative process, the bill was approved in the second vote with 32 congressmen in favor, 47 against, and 9 abstentions.A motion to reconsider the vote was rejected, ratifying the bill’s approval. With final approval secured, the bill will be enacted into law, and the Ministry of Health will implement the necessary measures for its execution.
Peru Congress Approves Bill to Expedite Access to Rare disease Medications
Q: What is the main purpose of the recently approved bill in Peru?
A: The primary goal of the legislation is to streamline access to medications and biological products for treating rare diseases, cancers, and othre complex conditions in Peru. This initiative aims to ensure that Peruvian citizens can receive timely, equitable, and high-quality treatments, upholding their essential rights to health and life.
Q: How does the bill aim to improve access to medications?
A: The bill establishes procedures to accelerate the registration and re-registration of medications and biological products already approved in countries with stringent health surveillance standards. It also includes an Accelerated Evaluation Procedure to reduce approval times, which is crucial for patients needing immediate treatment. Furthermore,the bill provides exemptions from certain requirements outlined in Law 29459,which regulates pharmaceutical products,medical devices,and health products.
Q: What diseases will this bill primarily affect?
A: This legislation is specifically designed to benefit patients with rare and orphan diseases, which frequently enough lack sufficient therapeutic options in the local market. The Ministry of Health will be responsible for defining and updating the list of rare and orphan diseases within 30 days of the law’s enactment, ensuring the list stays current with medical advancements.
Q: How does the Accelerated Evaluation Procedure work?
A: The Accelerated Evaluation Procedure sets a maximum approval period of 45 calendar days for medicines and biological products. If no response is received within this timeframe, a ”positive Administrative Silence” mechanism is triggered, automatically approving the product unless objections are raised within the specified period.
Q: what kind of products are eligible for this expedited process?
A: Products seeking registration must possess a Pharmaceutical Product Certificate or a Free Marketing Certificate, demonstrating that the medicine is authorized and marketed in countries with high health surveillance standards. This is to ensure the authenticity and quality of the products.
Q: what role did the Peruvian Congress play in passing this bill?
A: The Congress of the Republic of Peru gave its final approval to the bill. The measure was approved in the second vote with 32 congressmen in favor, 47 against, and 9 abstentions. A motion to reconsider the vote was rejected, ratifying the bill’s approval.
Q: Who is responsible for implementing the new law?
A: The ministry of Health will be responsible for implementing the necessary measures for the bill’s execution once it is enacted into law.