Any person or group in the Philippines can now legally import cheaper versions of branded medicines and sell them to the public, following the signing into law by President Gloria Macapagal-Arroyo on June 6 of the long-awaited Universally Acceptable Cheaper and Quality Medicines Act of 2008.

The only requirement is that individuals, organisations, retail chains and private hospitals who want to trade in cheap drugs should register with the Bureau of Food and Drugs (BFAD) beforehand, said the bill’s main sponsor, Senator Manuel Roxas. The legislation removes all roadblocks to parallel drug imports, and provides safeguards against the introduction of counterfeit medicines, he added.

With the bill’s passage, “we have completed, I believe, our legislative reforms in bringing affordable medicines to the people,” which began with the Generics Act of 1988, said Pres Macapagal-Arroyo. She has in the past expressed extreme impatience with the bill’s continued delays in Congress, which have been due to various factors including a controversial proposal requiring physicians to prescribe medicines by their generic names only. Following massive opposition by the medical profession, the president removed this provision from the final bill.

There have also been allegations of attempts by the multinational drug industry to get the bill overturned ever since it was introduced three years ago, and Sen Roxas warned legislators and the public to remain vigilant during the next 120 days, by which time the President requires the Department of Health to have produced implementing rules and regulations. There are “many” who have earned “so much” from the pharmaceutical market that they “would not want to see this law implemented successfully,” said Sen Roxas. ‘In any business where there is competition, the services improve and the prices go don. This is what this law will do to [the] drug industry,” he added.

Included in the final approved Act are amendments to the Intellectual Property Code aimed at boosting the domestic generics industry and establishing nationwide by 2010 15,000 Drugstores of the Village, the first of which were introduced last year. Drugstores must offer cheaper generic, parallel-imported versions alongside the branded originals, in order to give consumers greater choice, it stipulates.

It also allows: the granting of new patents only on newly-discovered uses of known drugs substances; local generics firms to test, manufacture and register their copy versions so they can be launched immediately after the originator’s patent has expired; the government to authorize, in cases of public emergency, the manufacture of drugs which are still under patent; and the President to establish ceiling prices for individual medicines, if the Health Secretary considers this to be necessary.

The Department of Health is also set to launch “very affordable treatment packs very soon for common diseases, at maximum prices of 100 pesos for a one-to-two-week treatment course,” said the Secretary, Francisco Duque. The government has stated that it is particularly targeting drug imports from India and Pakistan under the new freedoms, and Sen Roxas has urged the President to allocated at least 1 billion pesos for the government’s own parallel import programme.

Pres Macapagal-Arroyo has pledged that no provision in the final, approved version of the new law will now be changed, amended or removed. Its implementation will be monitored by a new congressional panel, the Quality Affordable Medicines Oversight Committee.