Warning: Attempt to read property "post_title" on null in /home/clients/58f2a29976672af522a8f4d82ffa28b6/web/wp-content/plugins/better-image-credits/better-image-credits.php on line 227

The World Health Assembly last week adopted ten guiding ethical principles for the donation and management of medical products of human origin – that is, the rising market for body parts.

“Prohibition of remuneration is indispensable for organ donation,” the delegate from Germany said during the Health Assembly, in order to “safeguard the vulnerability of organ donors” and combat “organ trafficking and organ tourism.”

The Report by the secretariat on Principles on the donation and management of blood, blood components and other medical products of human origin, including the ten guiding principles, was noted by the World Health Assembly during the 70th edition, taking place from 22-31 May. The ten principles relate to issues such as prior informed and voluntary consent of the donor, safety, quality and efficacy of donation, equity in donation, and financial neutrality.

Medical Products of Human Origin

Medical products of human origin are “all biological materials that are derived wholly or in part from the human body and are intended for clinical application,” according to the report. Examples of medical products of human origin are organs, blood and plasma products, ova, sperm and breast milk, the report states.

Medical products of human origin are unique in the sense that they depend on the donation of biological materials from living or deceased persons. This unique feature raises questions related to dignity and human rights of the donors and ethical standards in the procurement of the biological materials, the report states.

“The use of medical products of human origin is considered a beneficial and cost-effective treatment for several life-threatening or debilitating conditions,” the report said.

Ethical Principles

Marie-Paule Kieny, assistant director-general, Health Systems and Innovation at the World Health Organization, told Intellectual Property Watch that “the high-level principles, mainly avoiding exploitation, make sure that the most vulnerable people are protected.”

One of the principles states that “equity in donation should be promoted by engaging all segments of society in efforts to meet the need for medical products of human origin.” Another principle states “that prospective and actual donors of human biological materials for use in medical products should be protected against physical and psychosocial risks to the fullest extent possible.”

The report states that the principles may vary according to the different kind of products. Kieny said that medical products from human origin are “very diverse types of products.”

“Each principle should be further elaborated with strategic approaches and potential policy options and intervention for its attainment,” according to the report.

Kieny said the WHO secretariat looks forward to a further collaboration with interested member states to develop more specific guidelines for specific types of medical products of human origin in addition to the 10 guiding principles.

Several states, including Australia, Bangladesh, France, Lebanon, Colombia, and Panama, explicitly stated their support for the report.

The ten principles are “extremely important and relevant,” Pakistan said. The definition of the ethical principles makes it possible “to reflect the issue in legislation and regulation,” Colombia said. The ethical principles are critical due to the trafficking of human organs and other practices which threaten voluntary donation, according to Colombia.

Panama emphasised that there needs to be certainty that “all products from human body parts come from voluntary donors.” Malaysia said that “donors must be fully protected.”

Tunisia highlighted the need for capacity building and training to make sure that all member states will be able to implement the guidelines. Vietnam said there is still a lot of work to be done in developing countries. The United States highlighted the importance of sharing experiences between member states.

Nongovernmental group Medicus Mundi International stated that “the principles do not cover surrogacy, which involves donating the use of an organ, typically for payment, while it remains in the donor’s body.”

“The ethical principles may not adequately protect the rights of women donors involved in assisted reproductive technologies,” the group said.

Medicus Mundi also said that “donors may be forced to choose medical procedures that violate their fundamental rights and freedom” due to “gender, social and class dimensions.” The group urged WHO to “give special attention to the development of norms and principles.”

Financial Neutrality

Financial neutrality, established in principle 5, entails that the donation of biological materials does not cause a financial benefit, neither a loss for the donors. Kieny told Intellectual Property Watch that the principle of financial neutrality does not prohibit all forms of compensation. Several costs, such a transportation, may be reimbursed, but “there should not be a business” in medical products of human origin.

The report states different reasons why financial gain from the human body is problematic from an ethical perspective. One of the reasons is that financial gain “increases the risk of coercion and exploitation of potential living donors; it results in the inequitable distribution of the burden of donation, which in turn may result in stigmatization of donation,” it said.

Ecuador said the principle of financial neutrality “reduces the risks and eradicates the pressure on the donor for exploitation.”

Argentina added that the word “product” may open the door to commercialization of cells. Russia also stated that organs and reproductive cells should not be called “products”. The topic, according to Russia, is “closely linked to biotechnology and criminal law.”

Illegal trade in organs requires a legally binding instrument, according to Medical Mundi.

Shortages of Medical Products of Human Origin

Argentina stated that it is “far away from self-sufficiency in terms of cells and organs.” Tunisia mentioned that there are sometimes shortages in blood donation, especially during the Ramadan and the summer.

India stated that nations should have a right to prioritize the use of medical products of human origin for national needs to avoid transfer of medical products of human origin from poor countries to rich countries.

The International Federation of Red Cross and Red Crescent Societies stated that shortages remain in many countries and that blood transfusion is not available for those patients who need it most. It urged for an “expanded political commitment for vulnerable citizens.”

But, said Medicus Mundi, “unless public health institutions are strengthened, the receivers of medical products of human origin are mainly the patients who can afford private health care.”

Elise De Geyter is an intern at Intellectual Property Watch and a candidate for the LLM Intellectual Property and Technology Law at the National University of Singapore (class 2017).