The contested market of plasma.

Voluntary, anonymous free gift-giving has become the dominant norm for blood donation for transfusion purposes, in view of its established ability to satisfy the needs for labile blood products that meet satisfactory conditions of safety and cost. But the economy of blood products is also the place for one of the main exceptions to the principle of non-commercialization of body parts. I show that there exists a genuine international plasma market, which provides the raw materials to produce blood protein products by pharmaceutical industries. The recent years have seen a considerable strengthening of the massive and globalized features of this market. I briefly describe the issues that this evolution raises, and I sketch some directions for a partial resolution of these issues. I explain why the development of contract fractionation appears both possible and desirable from an economic perspective in the present context.

Economical impact of plasma fractionation project in Iran on affordability of plasma-derived medicines.

In Iran all transfusion services are concentrated under authority of one public and centralized transfusion organization which has created the opportunity of using plasma produced in its blood centers for fractionation. In 2008 voluntary and non remunerated Iranian donors donated 1.8 million units of blood. This indicates a 25/1000 donation index. After responding to the needs for fresh plasma and cryoprecipitate each year about 150000 L of recovered plasma are reserved for fractionation. In an attempt to improve both blood safety profile and availability and affordability of plasma derived medicines, Iran's national transfusion service has entered into a contract fractionation agreement for surplus of plasma produced from donated blood by voluntary non remunerated donors. In order to ensure safety of product produced, Iran has chosen to collaborate with international fractionators based in highly regulated countries. The main objective of this study was to evaluate the impact of contract plasma fractionation on the affordability of the plasma derived medicines in Iran. During 2006-2008, Iran's contract fractionation project was able to produce 46%, 18% and 6% of IVIG, Albumin and FVIII consumed in Iran's market, respectively. In contrary to IVIG and Albumin, due to fairly high consumption of FVIII in Iran, the role of fractionation project in meeting the needs to FVIII was not substantial. However, Iran's experience has shown that contract plasma fractionation, through direct and indirect effects on price of plasma derived medicines, could substantially improve availability and affordability of such products in national health care system.

[Traceability of drugs derived from blood: regulation and pharmaco-economic implications after 24 months of application in Paris CHU]. / Traçabilité des médicaments dérivés du sang: réglementation et implications pharmaco-économiques après 24 mois d'exercice dans un CHU Parisien.

Since January 1, 1995, the supply, stockage, dispensing and traceability of Blood Derivative Medicinal Products (BDMP) are subject to pharmaceutical regulations. A review of 24 months' application at Necker-Enfants Malades Hospital is presented and analysed. A distinction is drawn between two categories of BDMP: 1) anti-hemophilia BDMP, factors of plasma or recombinant origin; 2) non-anti-hemophilia BDMP, covering albumin, immunoglobulins (Ig), biological glues and other clotting factors. BDMP are subject to a hospital traceability procedure. In this respect, we have constructed a tryptic nominative model prescription, though dotations are granted for only certain prescription sectors (operating room, ICU) and certain products (biological glues, albumins). A dispensing-administration form is invariably attached to each bottle. Between January 1, 1995 and December 31, 1996, 8225 dispensing procedures for BDMP were recorded, with a total cost of 52,931,586 francs (i.e. 69% anti-hemophilia products v.s. 31% non-antihemophilia products). The Factor VIII market is divided more or less equally between factors of human and recombinant origin. The risk of viral transmission is considered to be virtually nil with recombinant products, despite their being stabilized by human albumin. The traceability rate of anti-hemophilia factors was 100%. Albumin consumption was 182,106 g at a cost of 3,358,250 francs. The following indications were adopted at a Local Medicines Committee: 1) in adults: hypoalbuminemia associated with edema or ascites; 2) in children: digestive disorders leading secondarily to exsudative enteropathy and/or hypoalbuminemia. Consumption of polyvalent Ig was 69,213 g, i.e. 10,856,722 francs. These products were prescribed in accordance with the directives of the Committee for Evaluation and Distribution of Technological Innovations. Consumption of specific Ig and biological glues may seem modest in relation to that of other products. BDMP expenditure appears particularly heavy here (about 26.5 MF/year) but consensual adoption of therapeutic guidelines has enabled rationalization of prescribing conditions with the best possible consideration of benefit/risk vs costs ratios. Traceability and drug safety monitoring procedures are linked to and integrated in the more global concept of Quality Assurance. Since January 1995, several withdrawals of batches have been recorded because of suspicion (or death due to) Creutzfeld-Jakob, or post-donation HIV seroconversion. In this area, the Hospital Pharmacist acts by the establishment in real time of a permanent safety link between the patient, a prescriber, an indication, a product prescribed and the product actually administered.

Is self-sufficiency financially viable and ethically justifiable?--the role of the National Blood Authority.

The National Blood Authority is committed to the principle of self-sufficiency but also supports the principle of clinical freedom and aims to improve patient care. Methods of increasing plasma yields are being investigated. On-going discussions are being held with the commercial sector concerning the range of products available and methods of improving manufacturing efficiency. It is believed that the NBA can become largely self-sufficient using blood given by the 2,000,000 voluntary donors.

Is self-sufficiency financially viable and ethically justifiable?--legal aspects.

There is no legislation specifically designed to compensate haemophilia patients who have been damaged by defective blood products. But there is a general regime, created as a result of the thalidomide tragedy, which deals with defective 'products'. It was introduced at the European level by the European Directive on Product Liability in 1985 and has been given effect in England by the Consumer Protection Act 1987. The rights of haemophilia patients who are injured by defective blood products depends on this Directive.

Is self-sufficiency financially viable and ethically justifiable?--a commercial viewpoint.

Manufacturers of blood products have to maintain the highest possible standards for plasma screening and good manufacturing practices to ensure maximum purity and viral safety. The private sector companies have much experience in implementing and complying with national and international regulations. These requirements involve considerable cost in the areas of (1) plasma collection facilities, (2) research and clinical research, (3) manufacture, and (4) quality control. Total self-sufficiency would mean the loss of many existing resources. An alternative would be a collaboration between the public and private sectors to meet the needs of all patients who require plasma derived products. The current definition of self-sufficiency suggests that it is not financially viable.

Economic issues in European self-sufficiency.

Future clinical practice in haemophilia care must make optimum use of resources and provide the highest quality products and services in an efficient and effective manner. Studies show that prophylactic therapy, compared with on-demand therapy, results in less time off work--that is, a smaller loss in productivity. However, prophylactic therapy requires a three- to five-fold greater annual amount of factor VIII than does on-demand therapy. Further study is needed to determine the optimum therapeutic strategy that gives the best cost v. benefit situation.

European regulatory issues.

Current EU regulations do not cover all aspects of the manufacture and control of blood products. Recent legislation coming into force on 1 January 1995 has established the European Medicines Evaluation Agency and introduced revised systems for approving pharmaceutical products, including blood products. There remains a need for comprehensive harmonized legislation covering plasma collection and screening, virus validation studies, and batch release.

Maternal serum alpha fetoprotein screening test in routine antenatal care : Is it cost effective in Cameroon?

Screening test for maternal serum alpha feoto-protein (MS-AFP) in routine antenatal care is compulsory in most developed countries to detect neural tube defect (NTD). With the cost of suck a programme; there was a need to evaluate its need in our environment. A high risk clinic was choosen for the recruitment of the subjects to maximize the risk. Incidence of NTD could be considered to be low in Cameroon compared to countries where screening for MS-AFP is compulsory. Coupled with the low socio-economic status of our population and the lack of infrastructures; we could conclude that this screening test on a routine basis is not cost-effective