On June 17, the ICC Board, along with some representatives of the Indian business sector engaged in the Pharmaceutical industry, met with Senator Mar Roxas for a dialogue on the Cheap Medicines Law which was signed by President Gloria Macapagal Arroyo.
Following is an overview and summary of the meeting which we hope will be informative and useful to other members who would wish to look into this, both as an opportunity to help reduce prices of medicines and also as a possible business venture.
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CHEAPER MEDICINES ACT OF 2008 / R.A. 9502
Philippines’ Republic Act 9502, otherwise known as the Cheaper Medicines Act of 2008, was signed into Law by President Gloria Macapagal Arroyo on June 06, 2008 in Calamba, Laguna.
This legislation has been actively sponsored and vigorously endorsed by Senator Mar Roxas. The need for this Law was made evident when Senator Roxas was made aware of the plight of the masses who could no longer afford the prices of much needed medicines while the same were available in other countries (particularly in India) at less than ¼ of the prevailing prices here.
The new Law has opened the doors for cheaper medicines to become a reality. The restrictions and obstacles to parallel importation of medicines from India and other countries with lower prices / cost are now done away with or minimized. While the Law has been passed and the parameters have been defined on what is allowed and what is not allowed, the government agencies will now be finalizing the Implementing Rules and Regulations (IRR) to complete the process.
Among the main elements of the Law are:
a. Allowing and Legalization of parallel importation of branded medicines by the private sector, as against the previous scenario which restricted parallel importation to the PITC.
b. Prohibition of re-patenting or extending of patents unless a major molectular change in the drug is proven.
c. Adoption of the “Early Working Doctrine” which allows processing of applications for patented drugs before the expiry so that it may be commercially sold immediately after expiry of the patent. In the past, such applications were accepted only after expiry, giving the original patent holder extra time of 2 – 3 years.
d. Government’s right to declare “National Need” as a justifiable reason for allowing patented drugs to be imported or manufactured and not just for “National Emergencies” on any medicine it requires (ex: SARS outbreak).
e. Price regulation and control is provided for in the new Law.
With the passage of the Law, the landscape of the Pharmaceutical industry in the Philippines is expected to change dramatically. Part of the change will depend on the involvement and how the business sector intends to put to good use the business opportunities for the new players. The Government hopes that the Law will allow free market forces to help increase competition, efficiency in business operations, and volume (more people being able to afford buying the needed medicines), and as a result, help bring down prices.
To better appreciate and understand the details of the Law, its implications, and the changes resulting in the Pharmaceutical Industry, Senator Roxas initiated a meeting in cooperation with the Indian Chamber of Commerce. The dialogue, held on June 17th at Drake room of the Discovery Suites, was attended by representatives of Indian companies who are engaged in the Pharmaceutical business and the Indian Chamber Board.
In attendance also were two officers of PITC as resource persons to shed light on both their current operations and the expected changes in the Industry as a result of the new Law. The dialogue proved fruitful as it provided much needed insight from both sides – the Government sector and private business.
With the Bill already signed into Law, the next order of business will be the adoption of Implementing Rules and Regulations to be formulated by the various agencies of Government. The private sector will have to actively participate in the discussions if we wish to have a smooth process that will encourage businesses to cater to the Pharmaceutical market. Senator Roxas likewise suggested to help the Chamber involve itself with the deliberations on the IRR if possible.
Towards this end, the Chamber will be organizing a Committee for the purposes of gathering inputs from businesses already in the Pharma industry, including new ones that would wish to join. The Committee will submit suggestions and if possible, attend and participate in the deliberations for the IRR.
We salute Senator Mar Roxas, for having supported the Legislation; we commend him for his unwavering concern and efforts in answering the needs of the masses. The success of the Law will now depend on the proper implementation by Government and the participation of the private sector. The dialogue conducted this week and the deliberations for the IRR will go a long way in helping ensure the success the Law.
