c. 1998 Religion News Service

NEW YORK _ One of the nation’s oldest and largest religious charities supplying medical aid to Third World hospitals is challenging World Health Organization guidelines on drug distribution that the group says puts the lives of thousands of people in jeopardy because they prevent badly needed medicine from reaching the poor.

Officials of the Catholic Medical Mission Board said that over a recent 11-month period, the agency was forced to refuse $27 million worth of donated drugs because of a WHO guideline requiring such medicines to have a remaining shelf life of at least one year when they arrive in a country.”The regulations are too restrictive on drugs that have a remaining shelf life of six, eight or nine months,”said Terry Kirch, executive director of the CMMB.”It will discourage responsible donations of drugs at a time when the needs of the poor are more acute than ever.” CMMB said the expiration-date requirement has forced it to turn down almost half of the drugs _ including antibiotics and vaccines offered by pharmaceutical companies _ that otherwise could go to battle disease abroad.

CMMB has asked WHO to reduce the shelf-life restriction to six months, which it says will allow a far greater volume of medical supplies to reach impoverished people.

Board officials cited cases in seven countries in Africa, South and Central America and the Caribbean where over the past two years shipments of drugs requested by doctors to treat outbreaks of certain infections, measles, mumps and hepatitis A were halted because of the shelf-life restriction.

The WHO guidelines were drafted in 1996 with the advice of 100 international agencies, charitable groups _ including CMMB _ and pharmaceutical companies, to combat widespread abuse such the dumping of drugs with questionable efficacy because of their out-datedness.

CMMB officials, however, said in many cases, because of logistical problems and bureaucratic delays, drugs may take as long as six months to reach their destinations. Often, arriving shipments have to be destroyed because of inadequate labeling or expired dates of use.

Defending the guidelines, WHO documents cite a case in which 11 Lithuanian women temporarily lost their eyesight after they were mistakenly given a veterinary drug because of inadequate labeling.

CMMB officials said they didn’t dispute that abuse exists, but argued the regulations need to be more flexible.”We can airlift drugs to a country in 30 days,”said Kirch.”It depends on the type of drug and the situation. The reality is, we can get the drugs to the people.” WHO officials said their guidelines clearly allow for exceptions to the 12-month rule, but CMMB said that in its experience government officials in receiving countries focus only on the rules’ highlighted sections and do not consider smaller print exceptions.

The guidelines, which WHO officials say are still under review, were not designed as international regulations. They contend it’s up to national governments to set their own policies based on such guides.

But Kirch says that because many poorer nations depend heavily on United Nations aid they are reluctant to impose rules that contradict those issued by a U.N. agency.

Field representatives from local organizations that receive CMMB supplies told reporters at a recent news conference of worsening conditions in several countries such as empty shelves in national warehouses normally filled with medical supplies and doctors unable to provide even basic treatment.”Children are dying from common diarrhea and respiratory problems. This is a sin,”said Pilar Martinez de Orduna, director of health clinics for the Foundation for Justice and Love in Mexico City.

Some hospitals in Zambia have not received any shipments of medical supplies since March and patients facing surgery are being forced to purchase their own sutures and gauze, said Dr. Victor Mukonka, district director for the nation’s health ministry.

A spokesman for Johnson & Johnson, one of 32 U.S. pharmaceutical companies participating in the worldwide charitable health program Produce to Give, said it has felt”minimal impact”from the regulations because it produces the drugs and supplies it donates only for specific orders.

While CMMB said it did not know of a specific company forced to dump drugs with shorter shelf lives because of the guideline requirements, waste probably occurs in some plants.”If there is no outlet for the drugs because of the shorter dates, I can’t image what they’re doing with them other than destroying them,”said Kirch.

DEA END RNS