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In 1996, the World Health Organization (WHO) developed a set of guidelines re-garding Drug Donations that reflect a consensus between the major international agencies active in humanitarian relief. They are not an international regulation, but are intended to serve as a basis for national or institutional guidelines, to be reviewed, adapted and implemented by governments and organizations dealing with drug donations.

There are several benefits that can be derived from the Guidelines and are as fol-lows:

• Provides a framework for improved drug donation practices and procedures.

• Serves as a support to a country’s national drug policy

• Requests for donations are more carefully solicited and formulated in keeping with the Guidelines.

• Helps to ensure the quality of donations.

Medicines will always be an essential element in alleviating suffering and interna-tional humanitarian efforts can greatly benefit from donations of appropriate drugs.

However, certain problems that can arise from drug donation are:

• Irrelevance to the existing emergency situation.

• Not appropriate for the prevailing disease pattern and level of care that is available in the community

• The quality of the drug may not always comply with standards in the donor country.

• The drugs may have a high-declared value. Import taxes and overheads for storage and distribution may be unnecessarily high and the inflated value of the donation may be deducted from the government drug budget.

• Drugs may be donated in wrong quantities, and some stock may have to be destroyed.

• Stockpiling of unused drugs can encourage pilfering and black market sales.

Probably, the most important underlying factor for these problems is the common but mistaken belief that in an acute emergency any type of drug is better than none at all. Moreover, there is usually a general lack of communication between donor and the recipient.

In summary, guidelines are needed because:

• Possible inconveniences and unwanted consequences may arise at the receiv-ing end.

• Communication barriers may interfere with how recipients can specify how they want to be helped.

• Donated drugs must be selected and distributed based on the existing policies and administrative systems in the recipient country.

• Quality requirements of drugs are different from other donated items.

In essence, drug donations must follow four (4) core principles:

• Maximum benefit to the recipient based on an expressed need.

• Respect for the wishes and authority of the recipient.

• No double standards on quality.

• Effective communication between donor and recipient.

The following articles (a-l) of the Guidelines rests on the four core principles (A-D) stated above and are distributed into four (4) main categories:

• Selection of Drugs

• Quality and assurance

• Presentation, packaging and labeling

• Information and management Selection of Drugs

• Must be based on an expressed need and is relevant to the disease pattern in the recipient country.

• Donated drug or their generic equivalence should be approved for use in the recipient country.

• The presentation, strength and formulation of donated drugs should, as much as possible, be similar to those commonly used in the recipient country.

Quality Assurance and Shelf Life

• All donated drugs; should be obtained from a reliable source and must comply with quality standards in both donor and recipient country.

• Drugs given to health professionals as free samples or issued to patients should never be included in the donation.

• Drugs should have a remaining shelf life of at least one (1) year.

Presentation, packaging and labeling

• All drugs must be labeled with their international non-proprietary names (INN) or generic names.

• They should be presented in large quantity packs, which are cheaper and less bulky to transport.

• Donations should be packed in conformity with international shipping regula-tions and must be accompanied by a detailed packing list specifying the con-tents of each carton by INN, dosage form, quantity, batch no., expiry date, volume, weight (should not exceed 50 kg) ; and any special storage condi-tions.

Information and Management

• Recipients should be informed of all drug donations that are being considered, prepared or actually underway. Information must include among others, type and quantity of donated drugs, expected date of arrival, port of entry, and the identity and contact address of the donor.

• Declared value of the donated drugs should be based upon the wholesale price of its generic equivalent in the recipient country or on the wholesale world-market prices of its generic equivalent.

• Costs of shipping, warehousing, post clearance and storage and handling should be paid in advance by the donor agency, unless specifically agreed upon otherwise.

2. Drug Donations in the Philippine Setting

In the Philippines, these guidelines shall be observed with amended principles in compliance with Philippine laws and policies. The Bureau of Food and Drugs (BFAD) issued Memorandum Circular No. 004-88, which stipulated the proce-dures to be followed regarding donations of pharmaceutical products in the coun-try.

Donated drugs are classified under accelerated registration wherein, only a test of the potency range of the active ingredients (as per label claim) is being conducted by the BFAD laboratory section.

The following government and private institutions are recognized to deal with drug donations and are required to secure accreditation from the Department of Social Welfare and Development (DSWD).

• Foundations

• Medical Missions

• Religious Missions

• Professional Groups

• Non-Governmental Organizations (NGOs)

• Political-based Organizations Documentary Requirements:

• Accreditation letter from DSWD

• Letter or Pledge of donation from group (s)

• Letter of Acceptance from Recipient

• SEC Papers (Optional)

• Letter of Exemption from the Department of Finance

• Letter from the Department of Health (DOH) Foreign Assistance & Coordina-tion Services (FACS) for endorsement to BFAD.

• List of Drug donations and quantity indicating on the label the following in-formation printed on the label and shall be in English or with English transla-tion.

• Formulation

• Generic Name/brand name, if any

• Dosage forms/strength

• Batch & lot number

• Expiry date. Drugs should have a shelf-life of at least six (6) months after the estimated arrival in the country of destination.

• Storage condition.

• Name and address of the manufacturer/distributor

• Bill of Lading/ Airway bill

• Plan of Action indicating where donated drugs are intended.

ONLY DRUGS HAVING SIMILAR PREPARATIONS REGISTERED WITH BFAD SHALL BE ACCEPTED AS DONATIONS.

THE FOLLOWING DRUGS ARE NOT ACCEPTABLE FOR DONATIONS:

× Dangerous Drugs

× Exempt-Preparation Drugs

× Drugs under the Monitored-Release Registration (New drugs)