DOH, DTI, IPO, and BFAD Issue Supplemental Guidelines to the Rules and Procedure for the Grant of Special Compulsory Licenses for Drugs and Medicines [Joint Administrative Order No. 2021-0001]
The Department of Health (“DOH”), the Department of Trade and Industry, the Intellectual Property Office of the Philippines (“IPO”), and the Food and Drug Administration issued Joint DOH-DTI-IPO-BFAD Administrative Order No. 2021-0001 (“JAO 2021-0001”) dated 03 May 2021 entitled “Supplemental Guidelines to Joint DOH-DTI-IPO-BFAD Administrative Order No. 2008-01, the Implementing Rules and Regulations of Republic Act 9502, Otherwise Known as the ‘Universally Accessible Cheaper and Quality Medicines Act of 2008’”. JAO 2021-0001 provides the grounds and procedure for the speedy resolution of petitions for Special Compulsory License (“SCL”).
Under JAO 2021-0001, SCL refers to the licensing of import and/or export of patented drugs and medicines under the Agreement on Trade-Related Aspects of Intellectual Property Rights or the TRIPS Agreement, as referred to in Section 93-A of the Intellectual Property Code of the Philippines. The IPO shall prioritize and promptly resolve petitions for SCL. The alternative dispute resolution mechanism on mediation proceedings will not be applied.
The procedure is initiated by a letter of intent to file the petition for SCL, which is submitted by the DOH Program Manager to the DOH-Pharmaceutical Division. The written petition must be verified by the Secretary of Health recommending that the IPO issue the SCL and stating that negotiations to purchase the patented drugs and medicines from the patent owner were conducted but no agreement was reached by the parties.
The petition for the issuance of SCL shall state any of the following circumstances:
- National emergency or other circumstances of extreme urgency;
- Where the public interest, in particular, national security, nutrition, health or the development of other vital sectors of the national economy as determined by the appropriate agency of the Government, so requires;
- Where a judicial or administrative body has determined that the manner of exploitation by the owner of the patent or his/her licensee is anti-competitive;
- In case of public non-commercial use of the patent by the patentee without satisfactory reason;
- If the patented invention is not being worked in the Philippines on a commercial scale, although capable of being worked, without satisfactory reason: Provided, That the importation of the patented article shall constitute working or using the patent; and
- When the demand for patented drugs and medicines is not being met to an adequate extent and on reasonable terms as determined by the Secretary of Health.
Within three (3) days from receipt of the petition and written recommendation from the Secretary of Health, the Director General of the IPO shall issue an Order directing the patent holder to file an answer to the petition. The patent holder is required to file the answer to the petition within ten (10) days from receipt of the Order.
The Director General of the IPOPHL shall immediately issue the SCL for the importation of patented drugs and medicines upon failure of the patent holder to file the answer to the petition, or upon review by the Director General that the petition satisfies the circumstances and the requirements for the issuance of the SCL.
The SCL to be issued by the Director General shall state the following:
- Authority of the DOH to import the patented drugs and medicines;
- Scope and duration of the SCL;
- Payment of adequate remuneration to the patent owner taking into account the economic value of the authorization payable in Philippine peso; and
- Requirement for the DOH to take reasonable measures to prevent the re-exportation of the imported patented drugs and medicines.
Upon issuance of the SCL, the Director General of the IPO shall immediately issue a notification to the DOH and the patent holder informing them of the terms and conditions of the SCL.
To avoid the commercialization and market distribution of the generic product, the Philippine Pharma Procurement, Inc., the authorized government agency, or the registered holder of the Certificate of Product Registration of the approved generic product shall design the packaging for the exclusive use of the government.