The tragedies in the early 1960s, related to thalidomide and the undermining of public confidence in pharmaceuticals led to the implementation of pharmacovigilance. Vigilance is not only a state of mind but also a method of surveillance. ‘Surveillance’ itself is the systematic on-going collection, collation and analysis of data for public health purposes and the timely dissemination of this information for assessment and public health response as necessary. There are two main types of surveillance approaches, one utilising data analysis to uncover trends in aggregating data to reveal new concerns or the efficacy of interventions; and the other approach utilizing a “sentinel network” to detect singular events promptly that may have public health impact. An example of the latter approach would be the recognition of the outbreak of West Nile Virus, a new infectious disease that has never been previously recognized, in the United States.
5.1 THE DEVELOPMENT OF GLOBAL GOVERNANCE OF MPHO
In 2004, the World Health Assembly adopted Resolution WHA57.18 on Cell, Tissue and Organ Transplantation. It placed responsibility on Member States to enforce measures for monitoring the procurement, processing and transplantation of SOHO as well as ensuring their accountability and traceability. Two Aide-Memoires have been published ad- dressing key safety measures for tissues and cells (10; 11) The implementation of vigilance and surveillance can facilitate the application of these measures. To be effective, the participation of national health authorities, scientific and professional societies, and health care professionals are required.
The International Health Regulations (IHR) (2005) is a global, legally binding framework against the international spread of disease, including public health emergencies and other public health risks. It sets out inter alia Member States’ rights and obligations with respect to national and international surveillance and notification to WHO of key outbreaks and other public health events. It also presents WHO’s functioning mandate including its responsibility to collect information about events through its surveillance activities and to assess their potential to cause the international spread of disease. The IHR were implemented in June 2007.
In 2009, the World Health Organization (WHO) updated its Guiding Principles for the transplantation of organs, tissues and cells. It noted inter alia that maintaining and optimizing their level of quality, safety and, efficacy requires the implementation of quality systems including traceability and vigilance.
In March 2010, the 3rd WHO Global Consultation on Organ Donation and Transplantation was held in Madrid. Its objective was to discuss the concept of national self-sufficiency in organ donation and transplantation and to outline strategies to achieve this goal. It was recognised that although there is a gap in the availability of organs for transplantation the needs of patients can better be met through greater awareness and involvement of the community resulting in an increase in donations.
In May 2010, following consideration of these Principles, the World Health Assembly adopted Resolution WHA63.22 on Human Organ and Tissue Transplantation. It urges Member States inter alia ‘to strengthen national and multinational authorities and/or capacities to provide oversight, organisation and coordination of donation and transplantation activities, with special attention to maximizing donation from deceased persons and to protecting the health and welfare of living donors with appropriate health-care services and long-term follow up’. These entreaties reflect the conclusions of the Madrid Consultation. The Resolution also requested WHO to continue collecting and analysing global data related to the transplantation of MPHOs, and to facilitate access by Member States to appropriate information including severe adverse occurrences. Recognizing the need for the surveillance of such occurrences, the World Health Assembly (WHA) (12) in May 2010, called on the World Health Organization (WHO) to facilitate inter alia Member States’ access to ‘appropriate information on the donation, processing and transplantation of human, tissues and organs, including data on severe adverse events and reactions’.
A substance of Human Origin legislation in the European Union (EU) covers the quality and safety of blood, tissues, cells and organs. Specific requirements are in place for their collection, testing, processing and distribution. Vigilance in the EU links four levels:
1. The European Commission, which plays inter alia a coordinating and supportive role and maintains the rapid alert system for blood, tissues and cells;
2. The European Centre for Disease Control (ECDC), which monitors health threats;
3. National Competent Authorities that ensure that the requirements of the EU Directives are followed;
4. Local tissue and cell establishments that are in the forefront when adverse occurrences are detected.
Directive 2006/86/EC (Article 7) requires Member States to provide the Commission with an annual report about serious adverse events and reactions notified to the Competent Authority.
In the case of ART, Directive 2006/86/EC (Article 6) identifies any type of gamete or embryo misidentification or mix-up as a serious adverse occurrence that must be reported. A summary report is prepared by the Commission and returned to all CAs, which are then required to make it available to tissue establishments.
For blood components, Directive 2005/61/EC requires Member States to ensure that those facilities where transfusion occurs have procedures in place to retain the record of transfusions and to notify blood establishments without delay of any serious adverse outcome observed in recipients during or after transfusion which may be attributable to the quality or safety of blood and blood components. Members States shall also submit a complete report on serious adverse reactions and events to the Competent Authority on an annual basis.
For organs, Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation ensures all organs can be traced from the donor to the recipient and vice versa, for a minimun of 30 years. Member States shall have a system in place to report, investigate, register and transmit relevant information about any serious adverse occurrence.