donors and collecting blood and plasma in for-profit or a not for profit environment

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1 Remunerated versus non-remunerated donors and collecting blood and plasma in for-profit or a not for profit environment ISBT Amsterdam, June 4, 2013 Jan M. Bult President PPTA

3 PATIENT CENTEREDNESS IT IS ALL ABOUT HOW TO PROVIDE PATIENTS WITH THERAPIES THEY NEED

4 Drivers for plasma collection Albumin Factor VIII Immuneglobulins

5 GLOBAL IVIG SALES FROM 1984 TO 2010 (Metric Tons) IVIG + SCIG +10.3% per year since % per year since S

6 IG Distribution in USA and Europe 60,000 US Immune Globulin li Europe: IG (iv + sc) 50,000 40, ,000 20,000 10,

7 PPTA Collection centers Source Plasma Collection Centers, May 2013 North America Europe Fractionator owned Centers Independent Centers Total

Collections in USA and Europe US Collections: Source Plasma 2002 2012* Europe Source Plasma

10,000,000000 000 8,000,000 6,000,000 4,000,000 2,000,000 0 13,824,54 45 12,644,462 2 10,317,674

8 Collections in USA and Europe US Collections: Source Plasma * Europe Source Plasma Collections ,000,000 22,000,000 20,000,000 18,000,000 16,000,000 14,000,000 12,000,000 10,000, ,000,000 6,000,000 4,000,000 2,000, ,824, ,644, ,317,674 10,368,480 12,442,214,821 15, ,817,869 22,028,860 19,807,473 23,573,445 12,442,002 *2012 through June

9 5,000 4,000 3,000 2,000 1,000 - TYPE OF PLASMA PROCESSED IN EUROPE FROM 1993 TO 2010 NON-PROFIT ORGANIZATIONS (Thousand Liters) 3,294 3,550 3,772 12,000 10,000 8,000 TYPE OF PLASMA PROCESSED IN EUROPE FROM 1993 TO 2010 COMMERCIAL COMPANIES (Thousand Liters) 10,677 6,000 4,801 5,424 1, , ,229 1,069 1,192 3,827 3,658 5,271 5,846 4,000 4,072 4,066 3,754 3,723 2,000 1, ,586 1, Source 1996 Plasma 1999 Recovered Plasma Source 1996 Plasma Recovered 2004 Plasma ,000 12,000 10,000 8,000 6,000 4,000 2,000 - TYPE OF PLASMA PROCESSED IN EUROPE FROM 1993 TO 2010 COMMERCIAL COMPANIES & NON-PROFIT ORGANIZATIONS (Thousand Liters) 6,358 5,449 4,425 4,855 5,136 5,560 5,844 3,940 11,746 5,859 6,654 5,176 4,983 4, Source 1996 Plasma Recovered 2004Plasma

10 500 TYPE OF PLASMA PROCESSED IN NORTH AMERICA FROM 1993 TO 2010 NON-PROFIT ORGANIZATIONS (Thousand Liters) 10,000 TYPE OF PLASMA PROCESSED IN NORTH AMERICA FROM 1993 TO 2010 COMMERCIAL COMPANIES (Thousand Liters) (100) Source Plasma Recovered Plasma 8,000 6,000 4,000 2,000-6,345 7, ,173 7,631 1, ,308 5,925 8,396 1,490 1,190 1, Source Plasma Recovered Plasma 10,000 8,000 6,000 4,000 2,000 - TYPE OF PLASMA PROCESSED IN NORTH AMERICA FROM 1993 TO 2010 COMMERCIAL COMPANIES & NON-PROFIT ORGANIZATIONS (Thousand Liters) 6,473 8,097 8,396 7,273 7,731 5,925 5,308 1, ,120 1,050 1,590 1,190 1, Source Plasma Recovered Plasma

11 There eeis nothing wrong in compensating / recognizing a donor for the time and effort made when it is done in a well regulated environment.

12 Ethics Underlying principle: DO NO HARM Plasma derived medicinal therapies are the long term life source for many patients with a variety of diseases. Without adequate plasma supplies the medical needs of many patients cannot be met. Compensating donors does not harm donors or recipients. Recognize the difference in donation frequency between the whole blood donor and a plasma donor.

plasma derived medicinal products A requirement for non-remunerated donors would

concern that information from donor may not be as reliable if financial

13 CPMP Position Statement 2002.BothB h non-remunerated and Remunerated donors contribute to the supply with safe plasma derived medicinal products A requirement for non-remunerated donors would create major supply problems.concern that information from donor may not be as reliable if financial compensation is used as an incentive although HIV infection also occurred in countries with non-remunerated donors. Now the risk factors have been identified and such donors are discouraged rigorous screening with state of the art techniques.safety of plasma derived-medicinal products is ensured by the application of a large number of complimentary measures

14 CPMP Position Statement 2002.validated production processes for plasmapheresis donors, including those who are remunerated, there are additional voluntary industry standards to ensure that plasma originates from a low risk donor population. These include qualified donor programs and inventory hold of donations.there is no evidence from clinical studies and pharmacovigilance that donor remuneration increases the risk of viral transmission via plasma derived medicinal products, which have been subject to proper screening at donation and a validated virus inactivation/removal step.volume of plasma obtained from non-remunerated donors is quite insufficient to satisfy demand.a requirement for unpaid or non-remunerated donors would create major supply problems and product shortages without any justification on grounds of safety..an exclusion of US-sourced Plasma for Fractionation for the reason that donors are remunerated would result in the exclusion of a population which is recognized as being at low-risk of exposure to BSE and therefore is at low risk of developing vcjd

inactivation / removal steps Finished product From the general public

15 PPTA Standards Donor population Donor selection Testing donations Relative e risk NAT testing Inventory Hold Dilution by pooling Virus inactivation / removal steps Finished product From the general public to the patient Both in addition to compliance with regulatory requirements

16 Residual Risk of Viral Agent Entering the Manufacturing Pool The presence of certain viruses in asymptomatic donors who are negative on the screening tests (window period donations) constitutes the major risk of viruses entering the fractionation process. The Residual Risk (RR) is the estimated probability of a potentially infectious plasma unit entering the manufacturing pool. Used to assess the impact of industry safety initiatives. The main viruses of concern are: HCV, HIV, and HBV.

17 Residual Risk HBV, HCV and HIV HIV and HCV Residual Risk 35 HBV Residual Risk Residual Risk / 10 6 Donations Residual Risk / 10 6 Donations HIV HCV

18 Round Table Discussion Round Table Discussion on Payment of Plasma Donors in Canada April 20, 2013 Dr. Graham Sher Chief Executive Officer

19 Summary PPPs from paid plasma equally safe to those from non-remunerated donors Without paid plasma donors, 70% of Ig for Canadian patients could be unavailable as well as other niche 600,000 incremental liters plasma for fractionation required to close the gap operationally and economically unfeasible in a volunteer non-remunerated model 19

20 Primum non nocere ( first do no harm ) Conclusion Patient access to safe and effective therapies dependent on paid plasma industry Safety of paid plasma industry is proven This is not a decision about safety Policy of payment or non-payment for plasma does not hinge on safety of finished product.

Source Plasma Safety

Source Plasma Safety Plasma May 15-19, 2017 George Schreiber, ScD, PPTA Director, Epidemiology Three components: Plasma Product Safety Donor Quality Manufacturing Pool Quality Fractionation Process Safe