Will lobby again kill bill assuring cheaper drugs?
LOBBY AT WORK: Too many Filipinos suffer or die just because they cannot afford to buy good medicine. Senate Bill No. 1658 seeking to provide quality and affordable drugs to the public has been sponsored by Sen. Mar Roxas to correct that.
The bill is the resurrection of a similar Roxas measure approved by the Senate in the last Congress — but dribbled to death by the House of Representatives until adjournment overtook it.
Its demise in the House had been traced to an expensive lobby by drug companies, some of them multinationals.
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COMPARISON: A comparative sampling shows some common medicines that are 2.5 to 40.3 times more expensive than the same drugs in India:
* Zantac (150 mg) for hyperacidity, costs P33.02 in the Philippines and 82 centavos in India (40.3 times more expensive).
* Ponstan (500mg) for headache and body pain, costs P24.82 in the Philippines and P3.22 in India (9.2 times more expensive).
* Plendil (5 mg) for high blood, costs P21.82 in the Philippines and P2.69 in India (8.1 times more expensive).
* Norvasc (5 mg) for high blood, P39.07 in the Philippines and P5.77 in India (6.8 times more expensive).
* Imdur (30 mg) for chest pains, P18.20 In the Philippines and P3.72 in India (4.9 times more expensive).
* Ventolin (100 mcg) for asthma, costs P315 in the Philippines and P126.78 in India (2.5 times more expensive).
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WRAPUP: The measure consolidates several bills into the proposed “Quality Affordable Medicines Act” that seeks to:
1. Amend patents laws to allow importation of more affordable medicines; support the development of the local generics industry, and give ample muscle to government in times of need.
2. Strengthen the Bureau of Food and Drug in foiling sale of fake or substandard medicines, partly by allowing it to retain its earnings for capital and other investments.
3. Authorize the President to impose price ceilings on life-saving drugs when the situation warrants it.
The co-authors of SB 1658 are senators Pia Cayetano, co-chair of the committee on health and demography, Manny Villar, Senate president, Sonny Trillanes, Migz Zubiri, and Loren Legarda.
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TRADE MARKS: The bill proposes to amend the Intellectual Property Code (unanimously approved by the Senate on final reading in the previous Congress) adopting international principles that promote public health.
It adopts the “international exhaustion” principle allowing the importation of affordable medicines from India, Pakistan, Thailand and other countries.
The present “domestic exhaustion” doctrine does not allow this. It has exposed government agencies and officials to lawsuits from pharmaceutical firms.
“We’re also amending some sections of the IPC related to trademarks and tradenames restrictions,” Roxas said.
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PATENT LIFE: To boost the generic drugs industry, the bill seeks to:
1. Disallow new patents for existing inventions under frivolous reasons of ‘new use’ or ‘new property.’ Allowing new patents based on ‘new use’ has unduly extended the patent life of drugs even without a significant change in the formula or content.
This practice, called internationally as the “ever-greening” of patents, has stifled the development of quality and affordable generic versions of patented medicines.
2. Adopt the “early working” principle, allowing local generics companies to start preparing for regulatory approval of generic versions of patented drugs even before the expiration of their patents.
At present, the patent life of a drug is practically extended for 3-4 years as generics firms are able to start development only right after the patent expires.
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FLEXIBILITIES: The bill allows the government to use private patents when public health is at stake.
The government or authorized third parties may use an invention even without the agreement of the patent owner when public interest so requires; when a judicial or administrative body has determined that a patent owner’s exploitation of his patent or license is anti-competitive.
Such flexible use is to be determined by the President, with adequate compensation to the patent owner, and will be immediately executory. No court, except the Supreme Court, can issue a temporary restraining order or preliminary injunction to stop or delay it.
These options are allowed under the Agreement on Trade-Related Aspects of Intellectual Property or TRIPS Agreement, which the Philippines and other developing nations fought for in the World Trade Organization.
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LAST RESORT: Economists Felipe M. Medalla and Cielito F. Habito, former Socioeconomic Planning Secretaries, said more competition is the best approach, and that imposing price controls may be incompatible with competition-enhancing policies.
An alternative mechanism in the bill as a “last resort” allows the President to impose price ceilings on recommendation of the Secretaries of Health and Trade and Industry, under any of these conditions:
1. An impending or existing calamity, or the effects of a calamity that affects public health.
2. The threat, existence or effect of a public health emergency as recognized by the DOH or by an officially recognized non-government organization.
3. Prevalence of widespread acts of illegal price manipulation of any drug or medicine.
4. An impending or existing event, or its effect, that causes artificial and unreasonable increase in drug prices.
5. Whenever the price of any medicine has risen to unreasonable levels.
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ABROAD: Roxas said other countries where giant drug firms operate have used the same tools with success.
Canada, Argentina, Thailand, Malaysia, and Indonesia have adopted the “early working” doctrine allowing generic companies to experiment with a drug before its patent expires. This gives them lead-time to market as soon as the patent expires.
Other countries, including Japan, Israel, and Thailand, have adopted the “international exhaustion” principle. This permits importation of the same drugs, thereby moderating domestic prices through competition.
The Indian Patent Act protects generic firms from lawsuits arising from “newly-discovered uses” for previously patented products.