Cheaper Medicines Act

How can the Law and its IRR make medicines more accessible & affordable to Filipinos?

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

What happens to violators of the Law and its IRR?

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.

What is parallel importation and how does it bring down the prices of medicines?

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.

 

What is the Cheaper Medicines Act?

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.

 

What is the early working or Bolar provision and how does it help bring down prices of medicines?

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.

Who are involved in the implementation of the Cheaper Medicines Act?

  • The Secretary of Health has special powers to be able to make informed decisions and ensure the full implementation of the Law.  Such influence extends even to the Local Government Units where the DOH shall actively engage in meaningful partnerships to ensure the Law is followed.
  • The DOH is the main implementing and monitoring agency for Cheaper Medicines Act but this is not a sole responsibility of the Department.  DTI, IPO, FDA, PhilHealth, PITC, PITC Pharma Inc. are all collectively working together to get the intent of the Law done.  Moreover, the Secretary can deputize any other government agency for any purpose related to the implementation and apt enforcement of the Law and its IRR.
  • Private Sector participation, partnerships, and advice are encouraged and sought in terms of monitoring implementation, building capacity, and reporting violations of the Law and its IRR.

 

Will Senior citizen’s discounts and discounts for people with disabilities still be honored on drugs with MRP?

With the Power to regulate prices, why not just regulate all drugs and medicines prices?

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.