The Law and its IRR intend to make medicines more accessible & affordable to Filipinos by enforcing provisions that improve market competition, availability, contain costs, improve healthcare provider and consumers behaviour, and when instances so require, even regulate prices.
a. Interventions to Improve Competition:
i. Parallel Importation of patented Medicines
ii. Required Production of Generic Drugs
iii. Promotion of quality generic drugs
iv. Enforcement of the Early working Provision for patented medicines.
b. Interventions to Improve Availability:
i. Compulsory Licensing for patented Medicines
ii. Special Compulsory Licensing for patented Medicines
iii. Government Use of Patented Medicines
iv. Mandatory Carry for patented parallel imports
v. Non-traditional outlets like Convenience Stores and supermarkets allowed to sell Over-the-Counter drugs
c. Cost containment Measures:
i. PhilHealth Reimbursements
ii. Government Pooled Procurement
iii. Consignment
d. Interventions to improve Professional behavior to serve the needs of the poor and vulnerable:
i. Generics only prescribing in government facilities and by government health workers
ii. Required use of generic terminology in all transactions including precribing for health workers and reimbursing for PHIC
e. Interventions to regulate prices
i. Imposition of Maximum Retail Prices
ii. Drug Price Monitoring by the Government
There are administrative sanctions that may be imposed by the Secretary of Health to violators. This is separate from any criminal or civil liability that may be incurred upon filing of appropriate charges in the courts of Law.
Parallel importation (Sec. 7), as applied to the local setting, is when a patented drug is brought into the country by Government or any private third party even without the consent of the patent holder as long as any of the 2 condition is met:
a. It has been introduced in the Philippines by the patent holder, or
b. It has been introduced anywhere in the world by the patent owner.
It allows for an importer to “shop around” for a good price for a patented product, bring this into the country and sell it to a more competitive and affordable price than the prevailing price of the same patented product sourced locally from the innovator company.
Example: a drug sold here at 45 pesos per tablet and sold at 8 pesos in another country, an importer may now bring the quality cheaper medicine in the country and sell it cheaper for our countrymen.
The Law intends to achieve better health outcomes for the Filipino people by assuring that quality medicines are accessible and affordable to as many Filipinos especially the poor.
There are a number of factors to be considered and a variety of issues and concerns to address when facing the problem of access to medicines. Among the major and critical issues include those of rational drug use, public perception on generics, health professional behaviour on prescribing and dispensing medicines, information asymmetry and exercising informed choice, pricing, supply and distribution, and procurement systems’ transparency, respect for patent rights vis-à-vis access by the poor, quality assurance, and many others. This is the reason why the Law too has many different interventions ready to address these critical and major issues.
This allows development, testing, and experimental work for the registration of a generic medicine to take place during the patent period of the innovator product. Such development, testing, and experimental work may last from 6 months to 2 years. Thus, this allows generic counterparts to be readily available and marketed the day after the patent expires instead of 2 years after. In contrast, without Bolar provision, a company may only apply for registration after the patent expires, in which case, the effective life of the patent is extended subject to the time it takes to complete said registration processes (usually 6 months to two years). By exerting the early workings provision for patented medicines, generic competition is facilitated and cheaper yet quality counterparts for expensive innovators become available earlier in the market.
The Law recognizes competition as the primary instrument to attain the best price and best quality for drugs and medicines through generics promotion. Competition also encourages innovation so we can have newer and better drugs. However, in instances that effective competition is not attained, the Law and its IRR provides for regulations of prices as well as of all the other factors that contribute to high and inaccessible costs of drugs and medicines. Thus, a balance between these two may be best for our countrymen to reap the full benefits of quality affordable medicines without compromising innovation for research for newer drugs.