Statement from International Transfusion Medicines Experts

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1 Statement from International Transfusion Medicines Experts Application for the Placement of Whole Blood (WB) and Red Blood Cells (RBCs) on the WHO Model Essential Medicines Lists (EML) Open Session of the 19 th Expert Committee Meeting on the Selection and Use of Essential Medicines Dr Che Kit LIN Chief Executive and Medical Director Hong Kong Red Cross Blood Transfusion Service 8 April 2013

2 Introduction Essential role of WB and RBCs for patient care is universally accepted and has been specifically addressed in a number of WHA resolutions and declarations WHA28.72: Utilization and Supply of Human Blood and Blood Products (1975) WHA58.13: Blood Safety: Proposal to establish World Blood Donor Day (2005) The Melbourne Declaration on 100% Voluntary Non remunerated Donation of Blood and Blood Components (2009) WHA63.12: Availability, Safety and Quality of Blood Products (2010) Access to safe blood and blood products is integral to global strategies for HIV and hepatitis prevention and to the achievement of Millennium Development Goals It is recognized as essential intervention for improving maternal and child health (Reproductive, Maternal, Newborn and Child Health Guidelines 2011) Blood transfusion is identified as one of nine essential, signal functions for providing Essential Obstetric Care (Joint WHO, UNICEF and UNFPA Guidelines 2009)

3 Application to place WB and RBCs on EML Though it aims to promote quality patient care, it has raised major concerns among policy makers and professionals working within blood systems at national and international levels A joint WHO, WTO and WIPO publication (2013) Promoting Access to Medical Technologies and Innovation the definitions distinguish blood products from medicines 'Blood products' as biologics therapeutic substances derived from the human body 'Medicines' as chemically synthesized substances intended for use in the medical diagnosis, treatment or prevention of disease WB and RBCs are not produced in the same way as medicines Harmonizing standards for the production of WB and RBCs as medicines will have major policy, legal, regulatory, financial, ethical and societal implications Weaken the foundation of national blood systems in many countries Developing countries particularly vulnerable

4 Legislation and regulation of WB and RBCs as medicines Globally, close to 100 countries, including EU countries have separate legislative and regulatory frameworks for WB and RBCs The adoption of different regulatory frameworks for blood and medicine in so many countries reflects the differences between blood and medicine The classification of WB and RBCs as medicines would require legislative changes in many countries to ensure compliance with regulatory requirements, notably GMP for the production and manufacturing of medicines This will have serious financial, infrastructure, logistics and ethical implications May threaten national capacity for self sufficiency in safe blood and blood products and for the security of the supply

5 Quality systems and GMP requirements All medicines used for patient care should be manufactured in compliance with internationally recognized standards and, specifically, with GMP If WB and RBCs are classified as medicines, they will be required to comply with GMP, this raises 3 important issues 1. Much of the blood chain lies outside the scope of GMP, which cannot address the inherent biological variations in the source 'blood donors, nor factors such as incidence/prevalence of infection in blood donors or quality of clinical transfusion practice 2. GMP compliance requires the full implementation of a standard and does not accommodate a stepwise implementation process or opportunities for improvement. Developing countries which are still struggling to establish basic quality systems and which are unable to comply with GMP standards will be left with even more limited access to a safe blood supply

6 Quality systems and GMP requirements 3. In the foreseeable future many countries, particularly developing nations, will be unable to provide WB and RBCs that meet GMP requirements in sufficient quantities to meet the transfusion needs of their populations The outcome will be less, rather than more, access to WB and RBCs This may force countries into purchasing them on the global market or make them susceptible to pressure from the for profit sector to permit the commercial production and supply of WB and RBCs obtained from paid donors

7 Commodification of WB and RBCs Blood is a living human tissue similar to cells and organs for transplantation. The donation of blood is comparable to organ donation 1997: The Oviedo Convention on Human Rights and Biomedicine explicitly prohibits any financial gain from the human body and its parts 2000: The Charter of Fundamental Rights of the EU Right to the Integrity of the Person, states that In the fields of medicine and biology, the following must be respected in particular: the prohibition on making the human body and its parts as such a source of financial gain The proposed addition to the EMLs would enable the pharmaceutical industry to exert pressure on countries to open their markets to WB and RBCs and to trade in their procurement, processing and distribution

8 Commodification of WB and RBCs There would be significant international public health risks if WB and RBCs were to be traded internationally in the same way as medicines The commodification and commercialization of blood is entirely contrary to WHA resolutions, global policies and international treaties that identify voluntary non remunerated blood donation (VNRBD) as the foundation of a safe and sufficient blood supply and preclude substances of human origin from becoming marketable commodities Concerns about the commodification of WB and RBCs extend to other substances of human origin, including cord blood, stem cells and organs

9 What has been learned from the placement of plasma derived medicinal products (PDMPs) on the EML Concerns about the potential negative outcomes of the placement of WB and RBCs on the EML in part derived from the case of PDMPs Inclusions of Factors VIII and IX, and IG on the EML have not brought the desired results of increased global availability and access There has been an exponential increase in paid plasma collection Source plasma collections have risen by ~ 15% per annum over the last decade and account for ~ 75% of the global plasma supply Source plasma is collected almost entirely by the private sector from paid donors in some countries, with an increasing volume of paid plasma being collected from students and poor populations Despite being on the EML for several years, the international distribution of PDMPs is inequitable, with disproportionately high consumption in countries with high GNP High prices and extensive use in high income countries have resulted in poor access to these blood products in countries with limited purchasing power

10 The EML and blood safety and availability The application makes a simplistic correlation between the inclusion of WB and RBCs on the EML and improved access to safe blood Does not address the complex interactions between national blood services, health care institutions, civil society and individuals who donate blood, nor the changes at the systemic level that are required for improved access to safe blood In view of the role of EML as important tools at national level to assist in the purchasing of medicines, inclusion of WB and RBCs in the EML would require procurement policies to subject it to a formal tendering process in which bids would have to be sought from rival suppliers Since blood and blood products are currently supplied by a single provider, such as the national blood transfusion service, this will imply seeking tenders from blood providers in other countries It may also prove to be an important opening for the commercial sector to enter the market in these countries

11 Implications for national goals of self sufficiency and security In 2010, the World Health Assembly deliberated on challenges to the availability, safety and quality of blood products and passed Resolution WHA63.12 The resolution defined self sufficiency in the supply of safe blood and blood components based on VNRBD, and the security of that supply, as important national goals to prevent blood shortages and meet the transfusion requirements of the patient population The definition of blood as a medicine through its inclusion on the EML will undermine the efforts of many countries to achieve or maintain selfsufficiency in a sustainable supply of WB, RBCs and other blood products based on VNRBD More seriously, it may cause a reverse in progress towards this goal and threaten the security of blood supplies

12 Need for assessment, review of evidence and wider consultation The application cites evidence on the comparative effectiveness, safety and costeffectiveness of WB and RBCs. However, because of the intrinsic differences between medicines and WB and RBCs, the EML Application Form, which was originally designed for manufactured medicines, does not provide an opportunity for the wider implications to be addressed For this reason, a systematic assessment and review of evidence should be conducted on the potential impact of the inclusion of WB and RBCs on the EML, with particular reference to the capacity of countries to ensure universal access and safe and appropriate use Assessment and review of evidence should focus particularly on the possible consequences in countries with limited resources, fragmented blood supply systems, poor legislative and regulatory frameworks, weak infrastructures and insufficient trained staff A far wider consultation with governments is required through the WHA, before any decision is taken

13 Comments on Reviewer 1 We agree with the Reviewer that there is no comparator for WB and RBCs the application highlights that one reason to include whole blood and red cells is to improve the safety of manufacture of blood products but it overstates the safety and the benefits do not always clearly outweigh the risks as is claimed WHO should be prepared to undertake an evaluation of the impact if whole blood and red cells are added to the EML We question the Reviewer that many countries manage blood products through the national medicines regulatory authority it is not therefore not at all clear that adding whole blood and red cells to the EML will achieve any significant public health or clinical gains We disagree with the Reviewer that whole blood and red cells be added to Section 11, Blood Products and Plasma Substitutes

14 Summary We contend that the application does not make the case that WB and RBCs meet the definition of medicines We believe that decision to include WB and RBCs on EML will classify blood as medicine will seriously endanger national blood systems and voluntary nonremunerated blood donations, particularly in low income countries We have strong concerns that it will have far reaching negative consequences on the safety, quality, availability, self sufficiency and sustainability of national blood supplies and will result in less patient access in many countries We urge that due consideration be given to the views and comments on the application from many international experts, institutions and organizations

15 Recommendations In view of the gravity of this matter and the potential negative impacts on the blood supply in many countries, we request the Expert Committee to 1. Facilitate a systematic assessment, review of evidence and analysis of the potential impact of the inclusion of whole blood and red blood cells on the EML 2. Engage in a broader, structured consultation with governments, national blood services, international and regional blood alliances and networks, nongovernmental organizations, national regulatory authorities, professional societies, international and intergovernmental organizations and developmental partners and other agencies providing financial support for the strengthening of national blood systems 3. Fully involve developing countries, which were not represented among the organizations submitting the application but which are likely to be most adversely affected 4. Defer any decision on the addition of WB and RBCs to the EML until fuller assessment and wider consultation have been completed

WORLD HEALTH ORGANIZATION. Blood safety: proposal to establish World Blood Donor Day

WORLD HEALTH ORGANIZATION. Blood safety: proposal to establish World Blood Donor Day WORLD HEALTH ORGANIZATION EXECUTIVE BOARD EB115/9 115th Session 25 November 2004 Provisional agenda item 4.6 Blood safety: proposal to establish World Blood Donor Day Report by the Secretariat 1. Blood