Global Serum Alliance
Budget
€25 — €0
EP Access
0
accredited persons
Staff
3
0.85 FTE
EU Grants
None
Mission & Goals
From the Articles of ESPA a. study questions relating to and defending the interests of the European Serum Processing Industry; b. represent its Members with the Commission of the European Communities, with other European institutions and with other national and international organizations whether in the private or the public sector; c. promote the harmonization of regulations covering the trade and the use of animal serum, following international standards set by the World Animal Health Organization (WOAH) and the World Health Organization; d. promote the education of Members, regulatory authorities and the serum industry stakeholders in general; e. consolidate the confraternal ties between all of its Members; f. permit the exchange of professional and technical information within the industry itself but also with all economic and scientific sectors; g. ensuring that the market for serum products operates in compliance with the EU rules and with any international rules such as WOAH
EU Legislative Interests
Examples include but are not limited to: - Regulation on the import and marketing of animal byproducts in EU (e.g., EC1069/2009 and EC142/2011) - Revision of EU pharmaceutical legislation, to ensure that areas utilizing animal byproducts are revised to reflect current research (e.g., EMA/410/01 rev.3) to ensure future supply chain safety and resilience - Initiatives under "One Health", specifically aimed at ensuring awareness among decision-makers, that the products ESPA represents are vital to ensure end secure future research, development and production of both animal and human medicinal products/therapeutics - The European Green Deal, specifically activities related to animal welfare and to sustainability by improved utilization of animal byproducts
Communication Activities
- Letters addressed to individual members of the Commission as well as DG's (e.g., SANTE, TRADE and GROW) aimed at educating about the use of animal sera in academia, biotech, development and manufacture of pharmaceuticals etc. - Stakeholder involvement with EMA, e.g., aimed at the planned revision of EMA/410/01 rev.3 in 2025/2026 - Giving input and ensuring progress in EU market access to USA for serum products (as covered by 4(C) and 4(D) certificates in EC142/2011), e.g., following up with individual MS to provide guidance to questions forwarded by USDA-APHIS via SANTE - Trouble shooting in specific cases related to trade and marketing of animal sera, e.g. Import of blood products into the EU from Colombia as summarized in the document "SANTE.DDG2.D.3/JOV/es(2022)2751672"
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
No memberships, but close collaborations include but are not limited to: - World Organization for Animal Health (www.woah.org/en/home) - Animal Health Europe (animalhealtheurope.eu) - International Meat Secretariat (www.meat-ims.org/home) - MedTech Europe (www.medtecheurope.org) - Danish Agriculture and Food Council (www.lf.dk) - Danish Industry Confederation (www.di.dk) - Direct comminucation with competent authorities in 3rd countries e.g., USDA-APHIS in the US (https://www.aphis.usda.gov), Instituto Colombiano Agropecuario - ICA in Colombia (www.ica.gov.co/home?lang=en-us), Department of Agriculture and Water Resources in Australia (https://www.agriculture.gov.au/) - National veterinary and food authorities of MS (primarily Denmark, Germany, Belgium, Ireland, France, Spain) - Representations of 3rd countries (mainly in Brussels, e.g., US embassy)
Organisation Members
SECRETIAT c/o Bureau de Vries ESPA MEMBERS Biosera France S.A.S. Rue de la Caille Fr- 49340 Nuaillé France marc@biosera.com www.biosera.com BioNord Sera Ltd 11C Ard Gaoithe Business Park Cashel Road Clonmel Co. Tipperary E91 H012 Ireland www.bionordsera.com Biowest Rue du Vieux Bourg 49340 Nuaille France www.biowest.net Sera Scandia A/S Automatikvej 1 Regus Officespace 2860 Søborg Denmark www.serascandia.com MSE SAS France 15 Rue du Mans F - 49300 Cholet FRANCE https://mse-sas.com/ SERANA EUROPE GmbH Dorfstrasse 17 A 14641 Pessin Germany www.serana-europe.com Sigma-Aldrich Chemie GmbH (Merck) Riedstrasse 2 89555 Steinheim Germany www.milliporesigma.com Seratek Biologicals Pty Ltd. Tourist Info Centre, Cnr Market and Roos Streets Clarens, 9707 South Africa. JBS S/A Av. Marginal Direita do Tietê, 500 Vila Jaguara CEP- 05118-100 | São Paulo – SP Brasil www.jbs.com.br Eurobio Scientific 7 Avenue de Scandinavie Fr- 91953 Les Ulis France www.eurobio-scientific.com Proliant (Entera Health) 2425 SE Oak Tree Court Ankeny IA 50021 USA www.enterahealth.com Proliant (Entera Health) Proliant Health and Biologicals C/o - APC Europe SLU Av Sant Julia, 246-258 Pol.Ind. Congost, ES-08403 Granollers www.essentiaproteins.com Probiomont S.A. José Batlle y Ordoñez 4841 Montevideo Uruguay Panymex International S.A. Calle 64 Este y Calle 50, PH Varibe, Oficina 104, San Francisco Panamá ADESTE Rua Paes Leme 524, 6º andar cj 64 Pinheiros , CEP 05424 904 São Paulo – SP Brasil www.adeste.com.br Seratek Biologicals Pty Ltd. Tourist Info Centre, Cnr Market and Roos Streets Clarens, 9707 South Africa. ESPA ASSOCIATE MEMBER PathoQuest 11 rue Watt FR-75013 Paris www.pathoquest.com
Additional Information
Offices in NL and BE are shared with other organizations, as is the secretariat accounting for 0.1 FTE, thereby allowing ESPA minimize cost to the benefit of its members.
Commissioner Meetings
No recorded meetings with EU commissioners.