How close is close? There is more to consider on this score than just the anticipated pace of the legislative mill as bicameral deliberations in the Philippine Congress get under way. The last leg of the bill's passage through both houses of Congress is the occasion for last-ditch efforts to ventilate on the perceived infirmities in the different versions of the proposed law (Senate Bill 1658 and House Bill 2844).

    And now the question of which between the two versions will prove resilient to the delibirations has also made the drug-price issue a battle between the Senate and the House of Representatives as well as a battle of personalities-in this case Senator Mar Roxas and Rep. Fernejel Biron.

To regulate or not

    A major bone of contention is the proposal under the House version to have a price-regulatory board that will set price ceilings, recommend drugs for price regulation, and undertake responsibilities for enforcement. The Senate version bestows this power only on the President under conditions of calamities, health emergencies, and instances when the prices of medicine are artificially jacked up or otherwise increase beyond reasonable levels.

    "The President's power to impose price ceilings is already found in the Price Act, and what we're doing is clarifying that such authority can be used for health emergencies, including ailments such as diabetes, which affects well over 10 percent of Filipinos," says Roxas, chief author of the Senate version.

    He intends to make a strong pitch for retaining this power in the hands of the chief executive, casting doubt on the ability of a price-regulatory body to fend off undue influences such as "under-the-table dealings, constant lobbying, and political pressure."

    Biron, a physician-lawmaker at the forefront of the bill's House version, is taking a dim view of the free-market environment being espoused in the Senate in the context of what he calls a "monopoly" of drug companies in the country.

    Likening the so-called "monopoly" in the drug industry to the situation in the Philippine oil sector, he defended the price-regulatory board as a means to even out a playing field where the big pharmaceutical companies are said to have a running start which new, smaller players would be hard-pressed to keep up with.

    The congressman said that Roxas's aspersions on the ability of the board to hold its own against pressures impugns the "integrity and competence" of individuals like Health secretary Francisco Duque III and Trade and Industry secretary Peter Favila who are likely to be part of the regulatory board.

    He adds that Congress can always exercise its oversight function to ensure that the board does its mandated job. Both versions provide for a congressional oversight committee composed of members of the Senate and House committees on trade and industry, health, demography, and finance.

    The Department of Health (DOH) itself has previously aligned with the Senate's position on the issue, taking exception with Biron's comparison of the two industries.

    "In the oil industry, it's okay to have a regulatory board," explains Health under-secretary Alex Padilla. "But in the drug industry it's not needed because the prices of these medicines in other countries can now be applied to us once this parallel importation of patented products is allowed."

    In a position paper, the Pharmaceutical and Healthcare Association of the Philippines (PHAP) laments the exclusion of industry representatives from the proposed regulatory body as a denial of representation that "exporting contracting parties" (e.g. pharmaceutical manufacturers and health-care providers) are entitled to under the General Agreement on Tariffs and Trade (GATT).

    The group also raises questions of transparency and accountability on price regulation determinations by the board. PHAP notes: "Determination of price ceilings for drugs and medicines … may pose additional burdens to our already overburdened government agencies … and give bureaucrats the power to make decisions that should be made only by qualified medical practitioners."

Putting blinds on brands

    Transferring the power to decide into less knowledgeable hands is also the key objection of the Philippine Medical Association (PMA) against another controversial provision under the House version amending the Generics Act. Certain PMA-affiliated subgroups put authorities on notice by sounding off their intention to go on a "hospital holiday" to signify their objection to Section 6b of HB 2844.

    Under section 6 of the bill, all medical, dental, and veterinary practitioners will be allowed only to write the generic name and not the drug brand in their prescriptions. Dr. Jose Asa Sabili, PMA president, says this endangers the patient's welfare, especially if the decision on what actual brands to purchase is left in the hands of nonexperts such as drug-store clerks.

    When the cost of medicine becomes pivotal to a patient's capacity to initiate or sustain treatment, he said it is now up to the doctor and patient to come to an understanding that will make the best of the situation. "That's when we must know how to meet halfway with our patients between considerations of cost and quality in their medication," he says.

    Dr. Rey Melchor Santos, PMA vice president, adds that even if a drug purchased is merely ineffective and does not do any active harm like inducing severe allergic reactions, the resulting delay in treatment can itself cause complications and further aggravate the disease.

     Furthermore, the PMA points out that it is still the physician who will absorb the liability for any adverse events arising from faulty drug dispensing, not the pharmacy or store clerk.

    Opthalmologist Minguita Padilla clarifies that choosing the right brand is most important for specialists who deal with highly sensitive diseases. Many generic medicines, she says, can do the job well enough for minor ailments.

    She refers to documented instances of faulty generic-medicine dispensation for sensitive conditions. According to Padilla, a 2007 incident in the province of Bohol involving a drug for uterine contraction after surgery resulted in at least one death and mutilation for five others.

    Padilla also questions Biron's motivations in pushing for the provision, noting that his family owns a generics-drug company and Biron himself is an officer of the company.

    The Philippine College of Physicians (PCP) echoes the call to retain the physician's prerogative to recommend a drug brand to the patient. In a statement, the PCP says: "Patients go to their physicians with full confidence that they marshal their medical education, skill, and experience in providing the best treatment for a given set of clinical circumstance. The patient-doctor relation-ship is sacred and cannot be undermined by legislation."

    If the physician's say in the prescription cannot be retained, the group said that the law should at least include a provision "shielding physicians from administrative, criminal, or civil suits for adverse effects of substitutions beyond their control."

    The group also called for the formation of a drug quality council composed of representatives from major medical societies and other stakeholders to tie in concerns for drug efficacy and safety with affordability.

BFAD on trial

    The undercurrent to the stated objections of medical professionals to the generics-act amendment is a lack of confidence in the ability of the Bureau of Food and Drugs (BFAD) to hold up its end in the bargain under the House version.

    Says Sabili: "The Generics Act of 1998 was enacted to enable our citizens to obtain cheap but effective medicine. However, due to the lack of support from the concerned government agency, we can say that it hasn't been successful."

    Santos says that BFAD itself admits to not having the capability to keep close tabs on the quality of all the drugs in the market. "The ratio of one BFAD regulatory officer to the number of establishments that have to be monitored is 1:200," he points out. "They have a problem also with monitoring the subsequent batches of medicines produced and they are also monitoring other products aside from drugs."

    A second proposed amendment to the Generics Act under the House version puts a heavier onus on BFAD to be more vigilant about drug quality. Section 6E of HB 2844 proposes labelling a generic drug with a BFAD-signed notice that its therapeutic efficacy is equal to that of any other product of the same generic name.

    BFAD is in no position to make that claim at the moment, implies cardiologist Saturnino Javier, director of the Philippine Heart Association, since the set of minimum requirements currently required by the agency for drugs to be approved for marketing are not enough guarantee for physicians.

    The varying bioequivalence of the different drug brands is an oft-cited quality concern that BFAD cannot answer for and only doctors, in their first-hand experience with the brands, can assess with any practical accuracy at the moment.

    Only the Senate version provides for the strengthening of BFAD in view of its critical role as the implementing arm of the proposed law. SB 1658 allows BFAD to keep its earnings and use it for expansion, upgrading, and modernization, a strategy that the government has been adopting with more and more key health institutions, notably tertiary-care centers.

Harmonizing the bills

    Roxas is optimistic that despite some areas of friction, the Senate and House versions are largely reconcilable with 80 to 90 percent of the provisions being in basic agreement. These include the pivotal amendments to the IPR allowing parallel importation, compulsory licensing, and government prerogative to override a medicine patent and produce generic equivalents in the public interest.

    Both bills are also doing away with the practice of "evergreening," patenting minor changes in the product to extend its patent cover, and are giving local generics manufacturers a running start through the "early working" principle-allowing access to a patented product for experimentation and testing two years before the patent expires.

    On the contentious issue of withholding the doctors' right to recommend drug brands, former House Speaker Jose de Venecia was quoted as saying that he and Biron are inclined to heed the doctors' appeal to remove the provision.

    Sen. Pia Cayetano, chair of the Senate health committee, sees a possible middle ground in the absence of immediate agreement on the contentious questions by suggesting the passage of a main version that incorporates the common provisions of the Senate and House versions. It remains to be seen however if the exclusion of the contentious sections won't critically impact on the real-world potency of the resulting legislation.

 

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