Press release about the decision made by the Parliamentary Ombudsman concerning the Complaint
Breastfeeding Support Association in Finland.
November 3, 2006
Informed consent missing in infant formula study in Finland - public health policy issues regarding commercial interests
The Finnish Parliamentary Ombudsman has found that an infant formula study has been conducted on thousands of newborns in several hospitals without obtaining proper informed consent from the parents. Additionally, the study was found to have been started and carried out for six months without ethical committee approval, and suffered from various other shortcomings.
The decision resolved a complaint by the Breastfeeding Support Association in Finland, filed in April 2004. The Associated asked the Ombudsman to find out the legality of an infant formula product development study with national health implications, funded by the Finnish infant formula manufacturer Valio and carried out by the National Public Health Institute of Finland.
The two major points in the complaint were to find out
1) whether the study fulfills informed consent requirements, when parents are not told enough about the benefits of breastfeeding nor the product development nature and commercial funding of the study
2) whether it is legal to distibute infant formula provided by an infant formula manufacture free of charge from the hospital with means which resemble the milk nurse practice of some infant formula companies.
The aim of the study was to find out whether removal of bovine insulin from infant formula would reduce type 1 diabetes (IDDM) and find out mechanisms leading to IDDM, whose prevalence in Finland is more than in any other country in the world. The Ombudsman lists lack of disclosure of the study's funding, lack of clear statement pointing the benefits of breastfeeding, lack of disclosure of the fact that the Principal Investigator working within NPHI is an inventor and benefactor in a patent on the research formula owned by the Finnish formula manufacturer Valio, as reasons for lack of capacity to give informed consent.
According to the Parliamentary Ombudsman's resolution, both National Public Health Insitute and the ethical committee failed in fulfilling their duties. The Ombudsman reminds that according to the Finnish Constitution, everyone has the right to life, personal liberty, integrity and security. No one shall be treated in a manner violating human dignity. Medical research has a connection to this basic right. The Ombudsman also cites the Declaration of Helsinki and international conventions on human rights in her decision.
The Breastfeeding Support Association of Finland notes that it's very worrying that there can be so many shortcomings in a study made on newborns, and practically no action is taken to fix the issues even when an official complaint is filed. Even now, after the resolution, it is not clear what if anything will happen to correct the omissions.
While the decision on the first part of the complaint affirmed the Association's doubts, the Association is disappointed that the Parliamentary Ombudsman's resolution stated that the Finnish legislation placing restrictions on gratis infant formula distribution is not meant to apply to medical research. This also appears to hold for food safety legislation.
The Breastfeeding Support Association will be looking into whether international conventions or European regulations require changes to legislation.
There are also health policy concerns. Vice chairperson Maarit Kuoppala: "Breastfeeding has many health benefits for both the baby and the mother, and supporting breastfeeding is an important public health issue. However, in Finland, only 32 percent of maternity and child health clinic nurses have even the basic training to support breastfeeding. Breastfeeding appears to be an issue not on any official's agenda. Thus it is very worrying if public research is driven by increasingly commercial interests."
According to "Good Research Practic, Handbook" (2005), NPHI, an institute operating under the Ministry of Social Affairs and Health to has outside funding which amounts to 40 percent of spending, and the policy is to get as much outside funding to carry out NPHI's plan of action as possible. Research on breastmilk was planned in the study but was not carried out due to lack of funding.
Background
The Breastfeeding Support Association in Finland is a volunteer association, founded in 1997, whose work is based on the United Nations Convention on the Rights of the Child (article 24) and WHO breastfeeding promotion programs.
The Association is funded by membership fees, advertisements in the Imetysuutiset newsletter and fees on training of volunteers. RAY (Finland's Slot Machine Association which funds health and social welfare projects) has awarded the association a grant for 2005/06 for the purpose of establishing a nationwide project, which includes the maintenance and advertising of the Breastfeeding Support Hotline.
The City of Helsinki has awarded the Association a small grant annually to support mothers in the Helsinki area. In the other municipalities in Finland some local groups have had opportunities to apply for grants from local social authorities.
The Finnish Parliamentary Ombudsman exercises oversight to ensure that public authorities and officials observe the law and fulfil their du ties in the discharge of their functions. In addition to authorities and officials, the scope of oversight includes also other parties performing public functions.
The Ombudsman's office aims to ensure good administration and the observance of constitutional and human rights.
The National Public Health Institute of Finland, according to it's website, promotes people's possibilities to live healthy life and is responsible as an expert body under the Ministry of Social Affairs and Health, for providing various professionals and citizens the best available information for their choices.
For more information:
The resolution Dnro 1016/4/04 by the Finnish Parliamentary Ombudsman, Finnish Parliamentary Ombudsman, October 25, 2006