21 JANUARY 2008

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 P C I J    I N V E S T I G A T I O N  —  PRICE-CONTROL-BOARD DEBATE MAY DELAY CHEAP DRUGS LAW


THE BOARD'S 'MISSING' MEMBERS
Yet if a price-control regime is an inevitable reality, its apparent lack of transparency and accountability is what the pharmaceutical industry — or at least the segment of the industry that represents multinational interests — is more worried about. The Pharmaceutical and Healthcare Association of the Philippines (PHAP), the industry association composed of 65 member companies (most of which are multinational corporations), specifically scores the exclusion of representatives from pharmaceutical firms, pharmacists, physicians, and hospitals from serving on HB 2844’s envisioned regulatory board.

“(T)he proposed legislation appears to deny pharmaceutical manufacturers and healthcare providers with any mechanism to provide input or have equal representation with other interested parties in government drug pricing determinations,” PHAP said in a position paper it submitted to the House of Representatives last year.

PHAP said that General Agreement on Tariffs and Trade (GATT) rules governing price control measures and the country’s other international trade pacts commit the Philippines to foster openness, transparency, and accountability in the areas of trade and investments. HB 2844, however, has no provisions for appropriate mechanisms for a dialogue with the pharmaceutical manufacturing industry and healthcare providers in the drug-pricing determination process.

Table 2: What the House and Senate Bills Propose

Source: HB 2844, SB 1658

Pertinent Amendments to Generics Act of 1988 (RA 6675):
SUBJECT
SENATE BILL 1658
HOUSE BILL 2844
Generic Terminology
None

House bill mandates all medical, dental and veterinary practitioners, including private practitioners, to write their prescriptions using only the generic name of the drug or medicine. It also orders that the following statement appear prominently on the label of a generic drug: “This product has the same therapeutic efficacy as any other generic product of the same name. Signed: BFAD.” (Section 6)

Penalty
None

House bill amends penalty schedule for violations of Section 6 of the Generics Act, as follows:

  • for the second conviction, a fine of not less than P25,000;
  • for the third conviction, a fine of not less than P25,000.00 but not exceeding P50,000 and suspension of his license to practice his profession for 60 days;
  • for the fourth and subsequent convictions, a fine of not less than P100,000 and suspension of his license to practice his profession for one year.

An administrative case may be instituted independently from the criminal case. (Section 12)

Akbayan party-list Rep. Ana Theresia Hontiveros-Baraquel justifies the absence of any role for pharmaceutical firms — particularly multinational ones — in the regulatory board, saying that having them represented as full members would contradict its mandate. But this only gives credence to a health economist’s contention that the bill has, from the outset, treated the industry as “criminals rather than stakeholders.”

“(It) is meant to punish the multinational drug industry and the large branded local drug industry, in some respects, and has no regard for the consequences of the actions that would follow,” says the expert. What adds to the air of animosity is that the regulatory board would have the power to impose administrative fines and penalties. “The board,” says the health economist, “becomes researcher (of drug prices), jury (pegging the prices), judge (finding violators), and executioner (levying fines).”

A TAINTED IMAGE
From the start, PHAP has opposed the passage of a bill that would amend the Intellectual Property Code. In PHAP’s view, not only would this weaken the patent system, “doing so will not translate into real, tangible, and long term improvements in the country’s healthcare system.”

Its arguments, however, have been clouded by the persistent public perception of pharmaceutical companies as “bad guys.” At one point, giant drug firms were even accused of using a P1-billion lobby fund to prevent the passage of the affordable medicines bill — an allegation PHAP has repeatedly denied. But it hasn’t helped that its lobbyists were involved in a “note-passing scandal” during a special session of the 13th House to question the quorum while the legislators were about to vote on the bill on third and final reading.

The recipient of that PHAP note, Rep. Locsin, has since gone on record to accuse the foreign pharmaceutical firms of being “terrorists” who are “mainly responsible for the health crisis in our country, along with their native lackeys in government, academe, and especially the callous and corrupt medical profession...for they have held this country and its government hostage to their greedy demand for unrestrained unconscionable profits.”

Table 3: What the House and Senate Bills Propose

Source: HB 2844, SB 1658

Pertinent Amendments to Pharmacy Law (RA 5921):
SUBJECT
SENATE BILL 1658
HOUSE BILL 2844
Sale of Medicines, Pharmaceuticals, Drugs, and Devices
None

House bill provides that non-prescription or over-the-counter drugs may also be sold in small quantities, not in their original containers to the consuming public through supermarkets, convenience stores, and other retail establishments.

The bill also limits sale of pharmaceutical, drug or biological manufacturing establishments, importers and wholesalers of drugs, medicines, or biological products only to retail drugstore, hospital pharmacies or to other drug wholesalers under the supervision of registered pharmacist, and supermarkets, convenience stores, other retail establishments for over-the-counter drugs, duly licensed by the Bureau of Food and Drugs. (Section 25)

Still, the dust has yet to settle in the debate over just how more Filipinos can be able to afford the medicines they need. At the Senate, Roxas had initially said he was keeping an open mind on the matter. But he was soon swayed against setting up a drug-price regulatory board during hearings conducted by the Senate Committee on Trade and Commerce, which he chairs.

Thus, while Senate Bill 1658 does have a medicine price regulation provision, it is meant only as a last resort. Patterned after the provisions of the Price Act (RA 7581), it bestows on the president the power to impose price ceilings on any drug based on the joint recommendations of the health and trade and industry secretaries, subject to certain conditions that may drastically affect public health.

What the Senate bill does, says Roxas, is to clarify the scope of a calamity so as to enable the President to declare a health emergency even in the absence of a devastating earthquake or typhoon. “For example,” he explains, “12 million Filipinos presently suffer from diabetes. That can be considered a health emergency already as that’s more than 10 percent of our population.”

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