The Dublin Consensus Statement
PLASMA – we need every drop of safe plasma we can get!
As you will know, IPOPI is a member of PLUS – the Plasma Product User Platform. As such we are keen to do our bit to bring concord to the ongoing ‘paid versus unpaid’ donor discussion.
We were keep supporters and sponsors of a recent landmark meeting in Dublin where global experts were brought together and following paper resulted. Unfortunately due to severe weather IPOPI’s David Watters was unable to travel to Dublin to take part – but to make up for that IPOPI was the first organisation to sign up to the final document on behalf of all our NMOs. We believe firmly that we need every drop of safe plasma that can be collected without bans or prohibitions on plasma whether it is sourced from paid or unpaid donors! We are not in that luxurious position and growing demand suggests that we are unlikely to reach that stage in the foreseeable future.
The Dublin Consensus Statement on vital issues relating to the collection of blood and plasma and the manufacture of plasma products
Brian O Mahony 1, Alison Turner 2
1 Chief Executive, Irish Haemophilia Society, Steering Group PLUS, Cathedral Court, New Street South, Dublin 8,Ireland
2 Chief Executive, National Blood Authority, Australia
The requirement for plasma products manufactured from both source and recovered plasma for the treatment of many medical conditions is projected to increase substantially in the course of the next 5 years [1]. Patient organizations representing many thousands of patients with rare disorders who are dependant on products manufactured from plasma formed a coalition of plasma users- PLUS- in 2009. PLUS represents the concerted views of seven organisations, the International Patients Organisation for Primary Immunodeficiency (IPOPI), the World Federation of Hemophilia (WFH), the European Haemophilia Consortium (EHC), Alfa Europe, Idiopathic Thrombocytopenic Purpura Support Organisation (ITP), Hereditary Angiodema International (HAEI), and Guillian Barre Syndrome Foundation International (GBS/CIDP).
Over the last thirty years, the manufacture from plasma of an increasing range of stable clinical products and the availability of plasmapheresis collection technology, has led to the development of a commercial industry based on plasma-only donations from remunerated donors. In countries that do not permit a remunerated donor system, plasma collections are limited to those collected by blood establishments operating with non- remunerated donors. The growing global requirement for safe and effective plasma products [1] to meet the health needs of patients mean that plasma from both the commercial plasma and the blood sectors are essential to provide the range and quantity of plasma products required. IPOPI estimate that less than 15 % of persons with primary immune deficiency worldwide are diagnosed and treated [2]. In 2007, there was a total of 26.5 million litres of plasma available for fractionation including 8.6 million litres of recovered plasma and 17.9 million litres of source plasma [1]. It is estimated that the global requirement for plasma for fractionation by 2015 may be 41.7 million litres even in the absence of any new indications for IVIG [1]. Patients who are dependant on these life saving therapies want to be reassured that they will have access to a sufficient supply of safe and effective therapy manufactured from the plasma of carefully selected and tested donors in the future.
National policies in most cases only permit a non – remunerated system of blood and plasma collection. This means that commercial plasma collections are limited to a few countries which allow both remunerated and non- remunerated donations including the United States of America, Germany, Czech Republic and Austria. Most countries utilize domestic non- remunerated blood collection in order to fully satisfy their requirements for labile blood components. However, the vast majority of these countries also import additional products from the commercial plasma sector to fully meet their health needs.
The plasma fractionation sector comprises both commercial and not for profit manufacturers and these compete in both global and national markets. Where both commercial and not for profit plasma collection or manufacturing systems co-exist or compete at a national level, there can be tensions and disagreements between the sectors on issues such as the relative safety profile of remunerated and non remunerated donors, as well as competition for donors. The science and the real requirement of patients are often lost in the ongoing discussions on donor remuneration, donor deferral policies, competition and the rights of donors. Patient organizations are concerned that unnecessary tensions between the sectors and differing ideas and concepts promulgated by other stakeholders and organisations could diminish their access to safe and effective therapy. In addition impediments to the appropriate movement of plasma products surplus to regional or national requirements can result in the waste of potential products that could be used to extend health care globally.
Both the blood and plasma sectors have developed their own codes of practice, a number of which find their origin in the 1975 World Health Assembly Resolution [3] on the utilization and supply of human blood and blood products. Codes include the International Society of Blood Transfusion’s Code of Ethics for Blood Donation and Transfusion [4] and a range of standards under the Plasma Proteins Therapeutic Associations International Quality Plasma Program (IQPP) certification [5].
PLUS believed that it was necessary and timely to convene a consensus conference to create a constructive dialogue between the key stakeholders. This conference was organized by PLUS and took place near Dublin, Ireland on January 7th and 8th 2010. The conference had the objective of drafting an initial consensus statement or set of principles to promote the development of ethical and safe systems of blood and plasma collection from human donors and the consequent manufacture of safe products for clinical treatment. In order to have a fully inclusive and comprehensive dialogue, it was necessary to ensure that the draft statement examined the collection of both blood and plasma and the manufacture of plasma derived therapies from both the industry and not for profit sectors, and considered the views of national blood authorities, patient and donor organizations.
The conference was attended by representatives from PLUS, the National Blood authorities from Canada, Australia and Ireland, the International Society of Blood Transfusion (ISBT), the commercial Plasma Protein Therapeutics Association (PPTA), the not for profit International Plasma Fractionation Association (IPFA), the European Blood Alliance (EBA), the World Federation of Hemophilia (WFH) and the International Federation of Blood Donor Organizations (IFBDO). The World Health Organization (WHO) attended as observers. The conference resulted in an excellent and constructive dialogue between all stakeholders. There was a clear willingness to engage in discussion on the difficult issues which divided participants. The end result was a comprehensive statement- the Dublin Consensus Statement.
The following statement was agreed by all the participants with the exception of the representative from IFBDO who none the less welcomed the initiative and the constructive dialogue. The WHO representative was present in an observer capacity and therefore could not agree any statement. Following the Conference, the Dublin Consensus statement was sent by the representatives present to their respective organizations seeking the endorsement of each of the organizations.
The production of this statement was viewed by all participants as an important step in improving dialogue that will promote a cooperative approach to the development of ethical and safe systems of blood and plasma collection and provide the best quality of care for both donors and patients. It was further agreed that the conference should be repeated in 2011 with the aim of further progressing work in this vital area.
References
1 Robert, Patrick, MRB Inc. Global Plasma Demand in 2015. International Plasma Protein Congress 3-4 March 2009: Paris, France
2 Personal communication ,David Watters, Chief Executive ,IPOPI
3 28th World Health Assembly, Geneva, 13–30 May 1975. Resolution 28.72 Utilization and supply of human blood and blood products
4 ISBT: A code of Ethics for Blood Donation and Transfusion. http://www.isbt-web.org/files/documentation/code_of_ethics.pdf , 2006
5 PPTA: Plasma Proteins Therapeutic Associations International Quality Plasma Program (IQPP) certification. http://www.pptaglobal.org/program/iqpp.aspx ,
Dublin Consensus Statement
Principles to apply to the collection and manufacture of blood components and plasma products
Introduction
The three major priorities for the global community in providing patients with adequate and safe blood components and plasma products are to:
a) Provide safe and sufficient blood components in all countries through the development of national blood transfusion systems based on voluntary non – remunerated donors.
b) Maintain sufficient and sustainable supplies of blood components from established blood transfusion services, based on voluntary non – remunerated donors.
c) Provide an adequate supply of plasma products from recovered and source plasma to meet patient needs on a global level.
The blood and plasma sectors comprise
• Blood establishments whose principal objective is the collection of blood for the production of blood components and in some cases plasma for further fractionation, and
• The plasma sector which collects plasma for subsequent fractionation into plasma derived medicinal products. Plasma products made from both non-remunerated and remunerated donations are currently essential to meet global health needs.
The donation of blood or plasma and its transformation into products that save and enhance the lives of patients is an invaluable contribution to modern healthcare.
Respect for individuals, maintaining the health of blood and plasma donors, and providing safe blood and plasma products for patients, are of utmost importance.
Countries and regions are entitled to have policies and practices on blood and plasma which reflect their political, cultural, ethical and economic contexts.
The blood and plasma sectors must operate within stringent national, regional and international regulatory regimes that support the production of safe and effective products.
The following principles provide the foundation on which the blood and plasma sectors should build their operations.
Principles
1. Patients
The absolute focus of the blood and plasma sectors in health care must be the patient.
1.1 Meeting the health needs of patients through a sufficient supply of safe and effective blood components and plasma products is the principal goal of the blood and plasma sectors.
1.2 Patients are entitled to expect that all stakeholders in the blood and plasma sectors will support their need for access to safe and effective products.
1.3 Patients whose continued health is dependant on the use of blood or plasma products have a right, through their representative organizations, to be consulted on any issue which may have an impact on the safety, efficacy or supply of the treatment they receive. Health Authorities should ensure that robust mechanisms are in place to ensure that this happens.
1.4 The blood and plasma sectors must ensure that their actions do not compromise the health status of those that receive blood components or plasma products.
1.5 The blood and plasma sectors should take all reasonable steps to eliminate the possibility of adverse reactions and events including transmission of pathogens. Risks vary from product to product and each product should be individually assessed.
2. Donors
2.1 The blood and plasma sectors must respect the intrinsic dignity of all people involved in the blood and plasma donation process.
2.2 The blood and plasma sectors and society in general should highly value all those who donate blood or plasma for the benefit of patients, recognize that donors perform a good action and treat donors with respect.
2.3 There is a limit to the capacity of the blood and plasma sectors to ensure the safety of blood and plasma products through testing and processing alone. It is therefore important that measures to defer donors are based on a precautionary approach and underpinned by evidence based assessment where feasible. Donors must have donor deferral policies clearly explained to them.
2.4 All people may offer blood or plasma to the community and their generosity is highly valued. However, the blood and plasma sectors have an obligation to only accept blood or plasma where the donor selection criteria are met.
2.5 All donors must give their free and informed consent prior to the donation.
2.6 All donors must be provided with clear and accessible information prior to their donation, which should include information on:
- The potential risks to them of donating blood or plasma,
- The intended use of their donation,
- who might benefit from their donation, including the health benefits for patients, benefits to the blood service and to any other party who facilitates the donation.
2.7 Donor information and samples will be kept private and confidential in accordance with relevant guidelines and legislation.
2.8 Donors should not be exploited by any individual or organization.
2.9 The blood and plasma sectors owe a professional duty to act in the best interests of those that donate and receive blood and plasma products.
2.10 The health of the donor should not be compromised by their donation.
2.11 Those seeking donations of blood and plasma may offer incentives for people to donate. Incentives offered will differ and reflect the social, economic, ethical and cultural environment in which the blood and plasma sectors operates. However, all incentives should be of a kind that
- pose no risk of harm,
- do not overwhelm the capacity of the donor to make an informed decision about whether or not to donate.
3. Sector relationships
The production of blood components and the manufacture of plasma products involve different manufacturing pathways, have access to different risk mitigation measures and the products are used to treat different diseases. The coexistence of two independent collection systems, one for blood and one for plasma, in the same region or country, could create a risk of shortage in the supply of blood components. Cooperation between the blood and plasma sectors is important to ensure that the best community outcomes are achieved including sufficiency of supply for patients.
3.1 Activities undertaken to support plasma collection should not compromise the ability of a nation or a region to collect adequate supplies of blood components to meet clinical needs.
3.2 Similarly, activities undertaken to collect or promote adequate supplies of blood products should take into account the ability of those who collect plasma for fractionation to meet the requirements of patients who rely on these therapies.
3.3 Organizations involved in whole blood and plasma collection should cooperate with the goal of ensuring the health of the donor and potential blood component and plasma product recipients.
3.4 The manufacture of blood components and plasma products to treat patients with very rare diseases should be welcomed and actively supported by all those that operate in the blood and plasma sectors.
3.5 All stakeholders in the blood and plasma sectors have the right to hold and express opinions and should treat each other with mutual respect.
4. Global utilization of donated blood and plasma
The products of the blood and plasma sectors are sometimes not needed to meet the blood and plasma product needs in that particular region. This is because a number of different products can be produced from a single fresh or plasma donation. Many regions lack the capacity to collect and produce all the blood products they need, so they are reliant on blood or plasma donated in another region. Donors expect their blood or plasma to be used to benefit patients who need blood and plasma products.
4.1 The needs of patients should determine the optimal collection of blood and plasma.
4.2 The Blood and plasma sectors have an obligation to donors to make their best endeavours to use that blood or plasma for the purposes for which it was donated.
4.3 Having satisfied the principal purpose for its collection, blood components, plasma and plasma intermediates not required for that purpose should be made available to meet the health needs of others and contribute to global health outcomes where feasible. Feasibility includes whether the costs of provision are able to be met and if the regulatory regime and healthcare systems in both regions supports availability.
4.4 Regulation of the collection and use of plasma for manufacture should be based on science and the precautionary principle, and facilitate global movement of products when safe and appropriate to do so.
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