Heavy responsibility

It is really quite difficult to write my first column for the New Year on a positive note because of the numerous bad news that continue to clog our channels of communication especially in the newspapers, radio, TV and even in the internet. In the midst of welcoming the New Year, we are still being bombarded with so many disastrous and tragic news about our less fortunate countrymen hardest hit by the natural calamities befalling them, not only last year but even during the past years.

Most regrettable and disgusting however are the continued sufferings of the victims of these devastating typhoons because of man-made disasters consisting of bad governance and criminal neglect of public officials in expeditiously and effectively providing relief and rehabilitation. Indeed as reported in media even the Yolanda victims are still suffering from lots of inconveniences up to now because of the poor quality of the houses in which they were relocated. Apparently public funds have been misused based on Commission on Audit (COA) report particularly on the part of the Department of Social Welfare and Development (DSWD).

More worrisome and quite alarming is the lack of transparency and truthfulness of this administration particularly in the Department of Health (DOH) regarding the implementation of the RH law. Under said law, public funds or the taxpayers’ money will be used to purchase “family planning commodities,” especially contraceptives that will be distributed and made available to the public for free particularly to poor women who need them for reproductive health purposes and for purposes of controlling the size of their family supposedly in the exercise of responsible parenthood.

In its decision on the RH law, the Supreme Court (SC) mandates the Food and Drug Administration (FDA) to certify that all contraceptive drugs and devices that are made available to the public are non-abortifacients, safe and pose no risks to the health of the Filipino people.

As defined in Section 4(a) of the RH law, an abortifacient is any drug or device that either (a) induces abortion or (b) induces the destruction of a fetus inside the mother’s womb or (c) induces the prevention of the fertilized ovum to reach and be implanted in the mother’s womb. It is thus quite clear that the law protects the ovum from its fertilization until it reaches and implants in the uterus.

In this connection, the FDA has been tasked to determine that the “family planning commodities” to be purchased by the government are not abortifacient by observing and strictly, faithfully and conscientiously following the SC decision. Hence during the budget hearing when DOH Acting Secretary Janet Garin asked for the approval of a budget of P1.025 billion for these family planning commodities, she assured Senator Teofisto Guingona III, the Chairman on the Committee on Health, that the FDA certification allowing the purchase by the government and sale or distribution to the public of various contraceptive drugs and devices would come out the first week of December, 2014.

There are currently fifty (50) pending applications for re-certification/re-evaluation of contraceptive drugs and devices filed by various pharmaceutical companies with the FDA. The Alliance for the Family Foundation, Philippines Inc (ALFI) filed its opposition to the said applications and to twenty seven (27) other contraceptive drugs previously registered by the FDA. ALFI also sought the recall and withdrawal of said drugs and devices from the market until a transparent, judicious, and credible process of re-certification and re-evaluation has been conducted.

In its opposition, ALFI has shown that, based on scientific and medical resources and materials, (1) every single hormonal contraceptive, IUD and injectable whether of “combined estrogen-progesterone formulation” or of a “progestin only formulation”, by its mechanism of action, causes changes in the uterine lining which make it harder for a fertilized egg to attach to the uterus, i.e., they inhibit implantation. Such changes also (2) induce the prevention of the fertilized ovum to reach and be implanted in the mother’s womb, that then (3) induce abortion or the destruction of the fetus in the mother’s womb which is precisely the definition of “abortifacients under the RH law.

ALFI also pointed out that these hormonal contraceptives, including IUD, injectable and implant previously registered with the FDA, which are still being sold in the Philippine market, invariably exhibit a mechanism of action that inhibits implantation of the fertilized egg. There are also documented harmful effects of these contraceptive drugs and devices on the health of women.

All these scientifically and medically proven effects of these drugs and devices are enough deterrents against the issuance by the FDA of a re-certification or its approval of the 50 pending applications of the pharmaceutical companies. They also constitute grounds for the recall of the twenty seven (27) other contraceptive drugs and devices previously registered by the FDA.

Quite alarming and disturbing in this connection is that the FDA has not yet set a public hearing of these applications by the pharmaceutical companies and ALFI’s specific  opposition  to any and all of these contraceptive drugs and devices. Obviously, even the assurance made by Garin during the Budget hearing to come out with such FDA findings and certification by the first week of December 2014, has not been complied with.

The FDA should thus be reminded of the warning issued by the SC itself on the gravity of the consequences in distributing and making available to the public of these contraceptive drugs and devices. The SC said: “A heavy responsibility and burden are assumed by the government in the supply of contraceptive drugs and devices, for it may be held accountable for any injury, illness or loss of life resulting from or incident to its use.”

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