Friday, May 29, 2009

Counterfeit Drugs 2: IPN Report on Fake Drugs in Poor Countries

Early this week, the International Policy Network (IPN,,  a think tank based in London, released its new report, “Keeping it Real: Combating the spread of fake drugs in poor countries”. The 28 pages long paper is also co-sponsored by 18 international think tanks from 18 countries, including Minimal Government Thinkers.

The new Report has some figures that can be shocking to patients. Among these are the following. One, fake tuberculosis and malaria drugs alone are estimated to kill 700,000 people a year. That’s more than 1,900 deaths per day and equivalent to four fully laden jumbo jets crashing every day. Two, the WHO estimates that counterfeit drugs constitute up to 25 per cent of the total medicine supply in less developed countries (LDCs). Three, 68 percent of artesunate (anti-malaria) drugs in Laos, Myanmar Cambodia and Vietnam contain insufficient active ingredients, rendering them less effective, if not totally useless, in curing the sick. Four, about 75 percent of imported counterfeit drugs come from India, according to one European Commission estimate; and China is also a significant producer of counterfeit drugs.

These figures are significant because the new “Cheaper Medicines Law” (RA 9502) has a provision legalizing “parallel importation” of locally-patented medicines, and the premise of this provision is that cheaper medicines to be imported will come from India, home to some 22,000 small drug producers, many of whom are informal.

Since the foreign manufacturers (Indian, Chinese, others) are different from the wholesalers, importers and local retailers, i.e., they are not one and the same company but several different companies, tracing of who will be accountable if the imported drugs are counterfeit or substandard that can result to adverse effects to the patients, will be difficult.

One of the dangers of taking fake drugs is failure to provide effective treatment. The Report says “as fake drugs usually contain insufficient bioavailable active ingredient, a patient who believes he is addressing his disease is in fact going untreated. The disease thus progresses, often leading to death, especially in children and the elderly.”

I attended this morning a round table discussion on "Quality issues in delivery of health care services: A Policy perspective” at the AIM Conference Center. The event was sponsored by the Health Policy Network (HPN) project of the Center for Legislative Development ( and was attended by mostly NGO leaders. A 30-page long paper entitled “Equity Issues in Access to Quality Health Care: A Policy Perspective” by the event organizer was also distributed to the participants.

Access for all to quality health care. This is a vision dreamed by almost all people in the world and is thus perfectly rationale. But resources are limited, the supply of well-trained doctors and other health professionals, the supply of good quality hospitals and clinics with sufficient laboratories and diagnostic instruments, the supply of safe and effective medicines and vaccines, are limited. While the demands for such health services and medicines are unlimited.

This is where the initial problem of access to quality health care arise. Add the fact that some people are too irresponsible to take good care of their own body and that of their own family, like those who drink and smoke heavily, take illegal drugs and fatty foods excessively, live in dirty places and do not observe personal hygiene, get into frequent fights, have sedentary and promiscuous lifestyle, etc.

Then add the fact that many governments think that medicines and health care are just like any other commodities like beer, hamburger and movies that must be slapped with multiple taxes and fees. That government corporations engaged in health insurance are accountable to the President and top politicians, and not to private citizens who were coerced to contribute to the health insurance funds.

One concept that was emphasized by the HPN is that for health care to be accessible, first it must be made available and second, it must be affordable. That is, available + affordable = accessible. While this may be correct in many cases, it does not mean that this will lead to “quality” health care which is the ultimate goal of all those public policies that people are talking about.

Take the case of those medicine warehouses managed and owned by some local government units (LGUs). During the MeTA forum last January in Manila, a World Bank-Philippines staff showed – complete with pictures – some of those medicine warehouses by big cities and provinces, where rats, garbage, useful and expired medicines are mixed in one room, often with no stable temperature control, some do not even have a thermometer to monitor room temperature.

Here, those medicines are available. They are more than affordable, they are distributed free. The poor patients in those LGUs therefore, have “access” to medicines. But do they get “quality” medicines that can cure them from their illness and diseases? Probably Yes, but probably No, and some may have contracted new diseases and complications if they happened to take substandard, expired or garbage-contaminated drugs.

It is not enough that there should be “more government budget for health care” as demanded by many sectors in society. Money can buy us subsidized or free medicines, safe and counterfeit alike, and money can also give us lazy and irresponsible government personnel who dispense expired and contaminated drugs.

More than bigger government taxation, regulation and intervention in health care, what is needed more is individual and parental responsibility for preventive health care, plus a competitive business environment where private health care providers and medicine producers can compete with each other in providing the safest and most reliable drugs and health care services to the people with varying health needs and varying financial resources.

Meanwhile, a physician friend thanked me for my paper on counterfeit drugs. She said that "there is a need to strengthen regulation and implement/add requirements to ensure product quality."

For me, more than regulation and government accountability, I want to see more corporate responsibility, that medicine producers and sellers should be directly accountable for all the products that they sell, no one else will be answerable should some things screw up later. Because counterfeit drugs is a very serious and criminal offense. A patient who waits for the medicine to cure him is actually waiting for his illness to mutate and evolve into a more dangerous disease because the medicine that he took was a fake or substandard.

And this is a big issue in parallel importation. If company A imported a cheap but countefeit medicine and the patient here died or developed a new diseases, that company should not say, "Oh I didn't know it was counterfeit, I only bought it from wholesaler X which he got from manufacturer Y in India. You should run after them, not me."

Whoever brought in the medicines, they alone should be accountable. If something bad happens to the patients who bought and took the drugs they sold, the importer and/or seller alone should go to the prison bars and pay indemnity to the affected patients, no one else. BFAD can only do so much, or it can even be possibly corrupted by some pernicious importers. Counterfeit or substandard drugs are sold dirt cheap because there was very little or zero research and innovation involved. By selling cheap, that alone will appeal to many poor patients, especially those who pinned their hopes in the "cheaper medicines law".

If corporate accountability is very clear and transparent, then I think counterfeiting can be drastically minimized. BFAD then will focus its limited resources and manpower on regulating those food and medicinal products produced and sold by enterprises which have hazy brand integrity.

Counterfeit Drugs 1: On the Growing Fake Drugs Worldwide, December 21, 2007

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