TIN:
SCHEDULE O
(Form 990)
Department of the Treasury
Internal Revenue Service
(Form 990)
Department of the Treasury
Internal Revenue Service
Supplemental Information to Form 990 or 990-EZ
Complete to provide information for responses to specific questions on
Form 990 or 990-EZ or to provide any additional information.
Attach to Form 990 or 990-EZ.
Go to www.irs.gov/Form990 for the latest information.
OMB No. 1545-0047
2021
Open to Public
Inspection
Inspection
Name of the organization
PLASMA PROTEIN THERAPEUTICS ASSOC
Employer identification number
52-1800187
52-1800187
| Return Reference | Explanation |
|---|---|
| FORM 990 | FORM 990, PART I, DOING BUSINESS AS: PPTA |
| FORM 990, PART III | LINE 4A, PROGRAM SERVICE ACCOMPLISHMENTS: INITIATIVES. PLASMA COLLECTION: PLASMAPHERESIS IS ONE OF THE MAIN WAYS TO OBTAIN PLASMA, ANOTHER TYPE OF PLASMA IS "RECOVERED PLASMA." THROUGH PLASMAPHERESIS, ONLY THE PLASMA IS COLLECTED AND THE BLOOD CELLS REMAIN IN THE DONOR. BLOOD DONORS LOSE PART OF THE OXYGEN-CARRYING CAPACITY OF THE BLOOD, WHICH IS RESTORED RELATIVELY SLOWLY. PLASMA DONORS ONLY LOSE THE PROTEINS IN PLASMA AND RETAIN THEIR CAPACITY FOR OXYGEN TRANSPORT. SINCE PLASMA PROTEINS ARE SYNTHESIZED MORE RAPIDLY THAN BLOOD CELLS, IT IS POSSIBLE TO COLLECT A LARGER VOLUME ON EACH OCCASION AND COLLECT FROM A DONOR MORE OFTEN. IN MOST CASES, BLOOD ESTABLISHMENTS HAVE ACQUIRED PLASMAPHERESIS EQUIPMENT AND DELIVER SOURCE PLASMA (APHERESIS PLASMA) DIRECTLY TO FRACTIONATORS. PLASMA COLLECTION CENTERS ARE REGULATED BY THE COUNTRY IN WHICH THEY ARE LOCATED, AS WELL AS THE COUNTRIES TO WHICH THEY MAY SUPPLY PLASMA FOR FURTHER MANUFACTURE. PLASMA COLLECTION IN THE US: MOST PLASMA CENTERS ARE LOCATED IN THE UNITED STATES AND THEREFORE, ARE LICENSED AND REGULATED BY THE FOOD & DRUG ADMINISTRATION (FDA). THESE PLASMA CENTERS ARE INSPECTED ON AN UNANNOUNCED BASIS AND MUST COMPLY WITH STRICT FDA REGULATIONS FOR DONOR SAFETY AND PRODUCT QUALITY. THEY MUST ALSO COMPLY WITH LABORATORY TESTING REGULATIONS UNDER THE US CLINICAL LABORATORY IMPROVEMENT ACT (CLIA) AND WORKER SAFETY REGULATIONS UNDER THE OCCUPATIONAL SAFETY AND HEALTH ACT (OSHA). VOLUNTARY STANDARDS: IN ADDITION TO GOVERNMENT-MANDATED REGULATIONS, THE PLASMA INDUSTRY ADHERES TO VOLUNTARY STANDARDS SET BY INDUSTRY, THE PPTA INTERNATIONAL QUALITY PLASMA PROGRAM (IQPP). THIS PROGRAM WAS ESTABLISHED BY PPTA SOURCE (FORMERLY ABRA) IN 1991. IQPP CERTIFICATION REFLECTS THE QUALITY OF A FACILITY'S DONORS AND THE PLASMA COLLECTED, THE PROFESSIONAL/MEDICAL OPERATION OF THE FACILITY AND A WELL-TRAINED STAFF. PPTA SOURCE ALSO DEVELOPED THE NATIONAL DONOR DEFERRAL REGISTRY (NDDR) AND THE CROSS DONATION CHECK SYSTEM (CDCS) IN THE U.S. THE NDDR IS DESIGNED TO BE USED BY PLASMA CENTERS TO CHECK DONORS AGAINST A COMPUTERIZED LIST OF PERMANENTLY DEFERRED DONORS. THIS SYSTEM SERVES TO FURTHER ASSURE THE SAFETY OF PLASMA AND PLASMA PRODUCTS. THE CDCS IS USED TO RECORD AND TRACK THE DATES OF A DONOR'S MOST RECENT DONATIONS TO ENSURE THAT THE INDIVIDUAL IS NOT DONATING MORE FREQUENTLY THAN IS PERMITTED BY FDA REGULATIONS. THIS SYSTEM SERVES TO FUTHER ASSURE THE SAFETY OF THE DONOR. PLASMA FRACTIONATION: ONCE THE SOURCE PLASMA IS COLLECTED, PPTA MEMBERS USE THE PLASMA TO PRODUCE LIFE-SAVING THERAPIES. THERAPIES INCLUDE ALBUMIN, USED IN EMERGENCY ROOM SITUATIONS AND TO TREAT CIRRHOISIS OF THE LIVER; COAGULATION THERAPEUTICS, USED IN THE TREATMENT OF VARIOUS BLEEDING DISORDERS; IMMUNE GLOBULIN THERAPEUTICS, USED TO TREAT A BROAD SPECTRUM ON IMMUNOLOGICAL AND NEUROLOGICAL CONDITIONS, AND ALPHA-1 PROTEINASE INHIBITOR, USED IN THE TREATMENT OF ALPHA-1 ANTITRYPSIN DEFICIENCY. THE ENVIRONMENTS IN WHICH THESE THERAPIES ARE MADE ARE TIGHTLY REGULATED. INTERNATIONALLY, THE EUROPEAN COMMISSION, THE COUNCIL OF EUROPE, THE WORLD HEALTH ORGANIZATION AND HEALTH AUTHORITIES WITHIN INDIVIDUAL NATIONS THROUGHOUT EUROPE AND THE PACIFIC RIM PARTICIPATE IN THE REGULATION OF THE INTERNATIONAL PLASMA DERIVATIVES INDUSTRY. IN THE UNITED STATES, THE FOOD AND DRUG ADMINISTRATION, THE NATIONAL INSTITUTES OF HEALTH, THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC), OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA), THE DEPARTMENT OF TRANSPORTATION, AND CONGRESS ALL MAINTAIN AND PRACTICE REGULATORY OVERSIGHT. IN ADDITION TO GOVERNMENT MANDATED REGULATIONS, PPTA MEMBERS ADHERE TO THE PPTA-DEVELOPED QUALITY, SAFETY, EXCELLENCE, ASSURANCE AND LEADERSHIP (QSEAL) PROGRAM. THIS PROGRAM, INITIATED IN 2000, COMPRISES A SET OF VOLUNTARY STANDARDS APPLICABLE TO MANUFACTURING FACILITIES. THE PROGRAM REQUIRES THE USE OF SOURCE PLASMA FROM QUALIFIED DONORS FROM CENTERS ADHERING TO PPTA'S VIRAL MARKER STANDARD, NUCLEIC ACID AMPLIFICATION TECHNOLOGY (NAT) TESTING FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV), HEPATITIS B (HBV), AND HEPATITIS C (HCV), PARVOVIRUS B19 NAT TESTING AND A 60-DAY INVENTORY HOLD(REDUCED TO 45 DAYS IN RESPONSE TO THE COVID-19 TRIGGERED PUBLIC HEALTH EMERGENCY). THE INVENTORY HOLD SERVES TO REDUCE THE PROBABILITY OF ANY WINDOW PERIOD DONATIONS FROM ENTERING THE MANUFACTURING POOL. HOLDING EACH DONATION FOR A PERIOD OF60 DAYS PRIOR TO POOLING ALLOWS MANUFACTURERS TO PREVENT SPECIFIC UNITS FROM BEING POOLED IN CASES WHERE A DONOR SUBSEQUENTLY TESTS POSITIVE FOR A VIRAL MARKER DURING THE 60-DAY PERIOD. THESE STANDARDS, IN CONJUNCTION WITH STATE-OF-THE-ART TESTING TECHNOLOGIES AND VALIDATED VIRAL INACTIVATION METHODS, HAVE HAD A POSITIVE IMPACT ON THE SAFETY OF PLASMA THERAPEUTICS. TOGETHER, THE VOLUNTARY STANDARDS PROGRAMS FURTHER ENHANCE THE QUALITY AND SAFETY OF PLASMA THERAPEUTICS. PPTA EUROPE WORKS CLOSELY WITH PPTA NORTH AMERICA TO BRING TOGETHER INDUSTRY EXPERTS FROM AROUND THE WORLD TO FOCUS ON IMPORTANT ISSUES RELATING TO THE QUALITY, SAFETY AND EFFICACY OF PLASMA THERAPEUTICS. FORM 990, PART III, LINE 4C, PROGRAM SERVICE ACCOMPLISHMENTS: CONSUMERS IN CANADA. IN EUROPE, IT IS THE RESPONSIBILITY OF THE NATIONAL GOVERNMENTS TO INFORM CONSUMERS ABOUT PRODUCT WITHDRAWAL AND RECALL INFORMATION. ON THIS BASIS PPTA EUROPE DOES NOT HAVE A PATIENT NOTIFICATION SYSTEM IN OPERATION. ENSURING CONFIDENTIALITY: MAINTAINING PATIENT CONFIDENTIALITY WAS ONE OF THE PRIMARY CONSIDERATIONS IN DEVELOPING THE SYSTEM. AN ADVISORY PANEL MADE UP OF REPRESENTATIVES FROM CONSUMER GROUPS HELPED DESIGN THE SYSTEM TO SAFEGUARD SENSITIVE PATIENT INFORMATION. TO ENSURE CONFIDENTIALITY, THE PATIENT NOTIFICATION SYSTEM IS OPERATED BY SEDGEWICK, AN INDEPENDENT ORGANIZATION THAT SPECIALIZES IN PHARMACEUTICAL NOTIFICATIONS. ALL PATIENT INFORMATION WILL BE HELD IN STRICT CONFIDENCE BY THE NATIONAL NOTIFICATION CENTER. FREE TO CONSUMERS: THERE IS NO FEE TO PARTICIPATE IN THE PATIENT NOTIFICATION SYSTEM. THE SYSTEM IS FUNDED BY THE PRODUCERS AND DISTRIBUTORS OF PLASMA-DERIVED AND RECOMBINANT PRODUCTS AND IS FREE TO CONSUMERS AND HEALTH CARE PROVIDERS. COOPERATIVE EFFORT BETWEEN INDUSTRY AND CONSUMERS: KEY CONSUMER GROUPS, INCLUDING ALPHA 1 ASSOCIATION, ALPHA ONE FOUNDATION, COMMITTEE OF TEN THOUSAND, HEMOPHILIA FEDERATION OF AMERICA, IMMUNE DEFICIENCY FOUNDATION AND NATIONAL HEMOPHILIA FOUNDATION, WORKED CLOSELY WITH THE PLASMA PROTEIN THERAPEUTICS INDUSTRY IN DESIGNING THE PATIENT NOTIFICATION SYSTEM. THE SYSTEM IS ADMINISTERED BY PPTA AND IS SUPPORTED AND FUNDED BY ALL MAJOR PLASMA-DERIVED AND RECOMBINANT MANUFACTURERS. A WORKING GROUP MADE UP OF STAKEHOLDERS AND INDUSTRY REPRESENTATIVES HAS BEEN FORMED TO PROVIDE INPUT ON THE SYSTEM AND MAKE ADDITIONAL RECOMMENDATIONS FOR FUTURE ENHANCEMENTS. HOW THE SYSTEM WORKS: FIRST, ANYONE INTERESTED IN PARTICIPATING REGISTERS WITH THE PATIENT NOTIFICATION SYSTEM AND PROVIDES GENERAL CONTACT INFORMATION, INCLUDING THEIR PREFERRED METHOD OF NOTIFICATION. PARTICIPANTS HAVE THE OPTION OF BEING NOTIFIED BY TELEPHONE, E-MAIL, OR TEXT, WHICHEVER IS MOST CONVENIENT FOR THEM. IF A PRODUCT IS WITHDRAWN OR RECALLED,THE COMPANY INVOLVED IMMEDIATELY CONTACTS SEDGEWICK WHO THEN NOTIFIES THE ENROLLED REGISTRANT DIRECTLY. EVERY EFFORT WILL BE MADE TO NOTIFY REGISTRANTS WITHIN 24 HOURS. IN ADDITION, CONSUMERS CAN CALL A 24-HOUR, TOLL-FREE NUMBER (1-888-UPDATE- U) FOR CURRENT INFORMATION ON PRODUCT RECALLS OR WITHDRAWALS. TO MAXIMIZE THE USEFULNESS OF THE SYSTEM, IT IS IMPORTANT FOR CONSUMERS TO KEEP ACCURATE INFUSION LOGS AND RECORD THE LOT NUMBER, PRODUCT NAME AND MANUFACTURER FOR ALL PLASMA PRODUCTS USED. HOW TO REGISTER: PARTICIPANTS CAN REGISTER ON LINE AT: WWW.PATIENTNOTIFICATIONSYSTEM.ORG OR BY CALLING 1-888-UPDATE-U. WORKING GROUP CONSUMER GROUPS: ALPHA 1 FOUNDATION COMMITTEE OF TEN THOUSAND FOOD AND DRUG ADMINISTRATION (FDA) GBS/CIDP FOUNDATION INTERNATIONAL HEMOPHILIA FEDERATION OF AMERICA HEREDITARY ANGLOEDEMA ASSOCIATION IMMUNE DEFICIENCY FOUNDATION JEFFREY MODELL FOUNDATION NATIONAL HEMOPHILIA FOUNDATION PLATELET DISORDER PLASMA PRODUCT PRODUCERS AND DISTRIBUTORS: BAYER HEALTHCARE LLC BIOGEN INC. BIO PRODUCTS LABORATORY LTD. BIOTEST PHARMACEUTICALS CORPORATION CSL BEHRING CANADA EMERGENT BIOSOLUTIONS GRIFOLS USA LLC KEDRION BIOPHARMACEUTICALS NOVO NORDISK, INC. OCTAPHARMA USA, INC. OCTAPHARMA CANADA, INC. PFIZER INC TAKEDA SYSTEM ADMINISTRATOR: PLASMA PROTEIN THERAPEUTICS ASSOCIATION 147 OLD SOLOMON'S ISLAND RD., STE. 100 ANNAPOLIS MD 21401 PHONE: (202) 789-3100 FAX: (410) 263-2298 WWW.PPTAGLOBAL.ORG SYSTEM OPERATOR: SEDGEWICK 2670 EXECUTIVE DRIVE INDIANAPOLIS, IN 46241 PHONE: 1-888-UPDATE-U 1-888-873-2838 WWW.PATIENTNOTIFICATIONSYSTEM.ORG |
| FORM 990, PAGE 2, PART III, LINE 4A | PPTA REPRESENTS THE INTERESTS OF THE PLASMA COLLECTION AND FRACTIONATION INDUSTRY WITH REGARD TO REGULATORY, LEGISLATIVE AND OTHER PUBLIC POLICY ISSUES. PPTA STAFF WORKS COOPERATIVELY WITH GOVERNMENTAL INSTITUTIONS AND REGULATORY AGENCIES THROUGHOUT THE WORLD. PPTA STAFF MONITOR REGULATORY AND POLICY ACTIVITIES (UNITED STATES CONGRESS, THE EUROPEAN COMMISSION, THE WORLD HEALTH ORGANIZATION, FDA, EMEA AND VARIOUS OTHER INTERNATIONAL AND NATIONAL REGULATORY AGENCIES AND COMMITTEES), COORDINATE INDUSTRY POSITIONS ON EXISTING, NEW AND EMERGING ISSUES, AND DEFINE AND DEVELOP STRATEGIC INITIATIVES THAT ENHANCE THE INDUSTRY'S REGULATORY ENVIRONMENT. PPTA SPEAKS WITH ONE VOICE ON ASSOCIATION AND MEMBER PROGRAMS. FOUNDED IN 1994, PPTA EUROPE, FORMERLY THE EUROPEAN ASSOCIATION OF THE PLASMA PRODUCTS INDUSTRY (EAPPI), IS THE PRIMARY ADVOCATE FOR THE LEADING PRODUCERS OF PLASMA-BASED AND RELATED RECOMBINANT BIOLOGICAL THERAPEUTICS. THE ASSOCIATION, THROUGH ITS WORKING GROUPS, DEVELOPS INDUSTRY-WIDE CONSENSUS POSITIONS AND INITIATIVES. PPTA EUROPE ACTS AS THE PRINCIPAL INTERLOCUTOR WITH REGULATORY AUTHORITIESON A NATIONAL AND EUROPEAN LEVEL AND WITH NATIONAL GOVERNMENTS. PPTA EUROPE IS COMMITTED TO BEING INVOLVED IN ALL DISCUSSIONS DIRECTLY RELEVANT TO THE PLASMA THERAPEUTICS INDUSTRY AND THE PATIENTS WHO DEPEND ON THE MEDICINES PRODUCED BY OUR MEMBERS. PATIENT NOTIFICATION SYSTEM: THE PATIENT NOTIFICATION SYSTEM IS A FREE, CONFIDENTIAL, 24-HOUR COMMUNICATION SYSTEM PROVIDING INFORMATION ON PLASMA-DERIVED AND RECOMBINANT PRODUCT WITHDRAWALS AND RECALLS IN NORTH AMERICA. THE SYSTEM WAS CREATED TO PROVIDE CONSUMERS WITH A SINGLE, CONVENIENT AND CONFIDENTIAL SOURCE FOR UP-TO-DATE PRODUCT WITHDRAWAL AND RECALL INFORMATION. LED BY THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION (PPTA), THE PATIENT NOTIFICATION SYSTEM WAS DEVELOPED BY THE PRODUCERS AND DISTRIBUTORS OF PLASMA PRODUCTS WITH DIRECT INPUT FROM CONSUMERS. ORIGINALLY AVAILABLE IN THE US, IN 2002, THE SYSTEM EXTENDED TO PPTA REPRESENTS THE INTERESTS OF THE PLASMA COLLECTION AND FRACTIONATION INDUSTRY WITH REGARD TO REGULATORY, LEGISLATIVE AND OTHER PUBLIC POLICY ISSUES. PPTA STAFF WORKS COOPERATIVELY WITH GOVERNMENTAL INSTITUTIONS AND REGULATORY AGENCIES THROUGHOUT THE WORLD. PPTA STAFF MONITOR REGULATORY AND POLICY ACTIVITIES (UNITED STATES CONGRESS, THE EUROPEAN COMMISSION, THE WORLD HEALTH ORGANIZATION, FDA, EMEA AND VARIOUS OTHER INTERNATIONAL AND NATIONAL REGULATORY AGENCIES AND COMMITTEES), COORDINATE INDUSTRY POSITIONS ON EXISTING, NEW AND EMERGING ISSUES, AND DEFINE AND DEVELOP STRATEGIC INITIATIVES THAT ENHANCE THE INDUSTRY'S REGULATORY ENVIRONMENT. PPTA SPEAKS WITH ONE VOICE ON ASSOCIATION AND MEMBER PROGRAMS. |
| FORM 990, PART VI | FORM 990, PART VI, SECTION A, LINE 6: MEMBERSHIP IN THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION SHALL CONSIST OF ORGANIZATIONS AND GROUPS OF ORGANIZATIONS WHOSE INTERESTS SUPPORT THE OBJECTIVES OF THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION AND MEET SPECIFIC CRITERIA SET FORTH BY THE ASSOCIATION'S BYLAWS AND ENFORCED BY THE GLOBAL BOARD OF DIRECTORS. MEMBERSHIP CLASSES SHALL INCLUDE: 1.GLOBAL MEMBERSHIP 2.REGIONAL MEMBERSHIP 3.COLLECTOR MEMBERSHIP 4.ASSOCIATE MEMBERSHIP FORM 990, PART VI, SECTION A, LINE 7A: EACH MEMBER SHALL BE INTERESTED IN SUPPORTING THE OBJECTIVES OF THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION AND SHALL BE ELECTED TO MEMBERSHIP AS PROVIDED IN THE BY-LAWS. MEMBERSHIP CLASSES SHALL INCLUDE: 1.GLOBAL MEMBERSHIP 2.REGIONAL MEMBERSHIP 3.COLLECTOR MEMBERSHIP 4.ASSOCIATE MEMBERSHIP ALL APPLICATIONS FOR MEMBERSHIP IN THE ASSOCIATION MUST BE MADE IN WRITING TO THE GLOBAL BOARD OF DIRECTORS (GBD) AND MUST BE APPROVED BY THE GBD. THE MEMBERSHIP APPLICATION MUST CONTAIN SUFFICIENT INFORMATION TO DEMONSTRATE COMPLIANCE WITH THE APPROPRIATE ELIGIBILITY REQUIREMENTS AND IN THE CASE OF APPLICANTS FOR GLOBAL MEMBERSHIP MUST INCLUDE TWO LETTERS OF ERECOMMENDATION FROM MEMBERS OF THE GBD SUPPORTIVE OF THE APPLICANT'S ETHICAL AND BUSINESS GOOD STANDING IN THE PLASMA PRODUCTS INDUSTRY. MEMBERSHIP APPROVAL REQUIRES THE AFFIRMATIVE VOTE OF AT LEAST TWO-THIRDS OF THE GBD. FORM 990, PART VI, SECTION B, LINE 11B: MANAGEMENT REVIEWED THE FORM 990 PRIOR TO FILING. FORM 990, PART VI, SECTION B, LINE 12C: ON AN ANNUAL BASIS, ALL OFFICERS, DIRECTORS, KEY EMPLOYEES, AND HIGHEST COMPENSATED EMPLOYEES ARE PROVIDED A COPY OF THE ASSOCIATION'S WRITTEN CONFLICT OF INTEREST POLICY, AND ARE ASKED TO REVIEW IT AS A REMINDER THAT ALL CONFLICTS OF INTEREST ARE TO BE REPORTED TO AN OFFICER OF THE ASSOCIATION AS SOON AS POSSIBLE AFTER THE DISCOVERY OF A POTENTIAL CONFLICT OF INTEREST SO THAT SAFEGUARDS CAN BE ESTABLISHED TO PROTECT ALL PARTIES. FORM 990, PART VI, SECTION B, LINE 15: THE PROCESS FOR DETERMINING THE COMPENSATION FOR THE CEO & PRESIDENT IS DURING AN EXECUTIVE SESSION OF THE BOARD OF DIRECTORS, THE BOARD DISCUSSED THE GENERAL SALARY AND BENEFIT LEVELS OF PEOPLE IN SIMILAR POSITIONS. SURVEYS AND GENERAL PERSONAL EXPERIENCE OF THE BOARD WERE USED IN DECIDING THE COMPENSATION PACKAGE OF THE CEO & PRESIDENT. FOR THE TOP MANAGEMENT STAFF, GENE STROSHANE, PPTA VP FINANCE & OPERATIONS, REVIEWS A REPORT OF THE COMPENSATION, INCLUDING BONUSES, WITH THE COMPENSATION COMMITTEE OF THE BOARD (CHAIRMAN AND TREASURER). THEY DISCUSS THE SALARY LEVELS OF THE STAFF AND REVIEW FOR REASONABLENESS BASED ON EXPERIENCE WITH THE FUNCTIONS WITHIN THEIR OWN ORGANIZATION AS WELL AS PERSONAL EXPERIENCE IN OTHER NON-PROFIT BOARDS THAT THEY ARE A PART OF. FORM 990, PART VI, SECTION C, LINE 19: PPTA MAKES ITS FORM 990 AVAILABLE TO THOSE WHO REQUEST. THE GOVERNING DOCUMENTS AND AUDITED FINANCIAL STATEMENTS ARE NOT GENERALLY MADE AVAILABLE TO THE GENERAL PUBLIC, BUT IF REQUESTS FOR COPIES OF THESE DOCUMENTS WERE TO BE RECEIVED, THE ORGANIZATION WOULD CONSIDER MAKING THEM AVAILABLE TO THE REQUESTOR. |
| FORM 990, PAGE 6, PART VI, LINE 6 | MEMBERSHIP IN THE PLASMA THERAPEUTICS ASSOCIATION SHALL CONSIST OF ORGANIZATIONS AND GROUPS OF ORGANIZATIONS WHOSE INTERESTS SUPPORT THE OBJECTIVES OF THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION AND MEET SPECIFIC CRITERIA SET FORTH BY THE ASSOCIATION'S BYLAWS AND ENFORCED BY THE GLOBAL BOARD OF DIRECTORS. MEMBERSHIP CLASSES SHALL INCLUDE: 1. GLOBAL MEMBERSHIP 2. REGIONAL MEMBERSHIP 3. COLLECTOR MEMBERSHIP 4. ASSOCIATE MEMBERSHIP |
| FORM 990, PAGE 6, PART VI, LINE 7A | EACH MEMBER SHALL BE INTERESTED IN SUPPORTING THE OBJECTIVES OF THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION AND SHALL BE ELECTED TO MEMBERSHIP AS PROVIDED IN THE BY-LAWS. MEMBERSHIP CLASSES SHALL INCLUDE: 1. GLOBAL MEMBERSHIP 2. REGIONAL MEMBERSHIP 3. COLLECTOR MEMBERSHIP 4. ASSOCIATE MEMBERSHIP ALL APPLICATIONS FOR MEMBERSHIP IN THE ASSOCIATION MUST BE MADE IN WRITING TO THE GLOBAL BOARD OF DIRECTORS (GBD) AND MUST BE APPROVED BY THE GBD. THE MEMBERSHIP APPLICATION MUST CONTAIN SUFFICIENT INFORMATION TO DEMONSTRATE COMPLIANCE WITH THE APPROPRIATE ELIGIBILITY REQUIREMENTS AND IN THE CASE OF APPLICANTS FOR GLOBAL MEMBERSHIP MUST INCLUDE TWO LETTERS OF RECOMMENDATION FROM MEMBERS OF THE GBD SUPPORTIVE OF THE APPLICANT'S ETHICAL AND BUSINESS GOOD STANDING IN THE PLASMA PRODUCTS INDUSTRY. MEMBERSHIP APPROVAL REQUIRES THE AFFIRMATIVE VOTE OF AT LEAST TWO-THIRDS OF THE GBD. |
| FORM 990, PAGE 6, PART VI, LINE 11B | NO REVIEW WAS OR WILL BE CONDUCTED. |
| FORM 990, PAGE 6, PART VI, LINE 12C | ON AN ANNUAL BASIS, ALL OFFICERS, DIRECTORS, KEY EMPLOYEES, AND HIGHEST COMPENSATED EMPLOYEES ARE PROVIDED A COPY OF THE ASSOCIATION'S WRITTEN CONFLICT OF INTEREST POLICY, AND ARE ASKED TO REVIEW IT AS A REMINDER THAT ALL CONFLICTS OF INTEREST ARE TO BE REPORTED TO AN OFFICER OF THE ASSOCIATION AS SOON AS POSSIBLE AFTER THE DISCOVERY OF A POTENTIAL CONFLICT OF INTEREST SO THAT SAFEGUARDS CAN BE ESTABLISHED TO PROTECT ALL PARTIES. |
| FORM 990, PAGE 6, PART VI, LINE 19 | NO DOCUMENTS AVAILABLE TO THE PUBLIC |
| FORM 990, PART VII | FORM 990, PART III, LINE 4D, OTHER PROGRAM SERVICES: SYSTEM FOR REPORTING MONTHLY SUPPLY AND AVAIABILITY DATA. IN RESPONSE TO PUBLIC HEALTH-RELATED CONCERNS REGARDING PRODUCT SHORTAGES, PPTA NORTH AMERICA BEGAN COLLECTING AND PUBLISHING DATA ON THE DISTRIBUTION OF IMMUNE GLOBULIN, HIGH PURITY FACTOR VIII, RECOMBINANT FACTOR VIII, AND ALBUMIN. THIS INFORMATION HAS BEEN PUBLISHED ON A MONTHLY BASIS SINCE 1998, IN COMPLIANCE WITH THE SPECIFIC RECOMMENDATION OF THE ADVISORY COMMITTEE ON BLOOD SAFETY AND AVAILABILITY, AS WELL AS THE EXPECTATIONS OF FDA, HHS, PATIENTS, PHYSICIANS, AND OTHER STAKEHOLDERS. QUALITY & SAFETY THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION AND THE INDUSTRY IT REPRESENTS, TAKE VERY SERIOUSLY THE QUALITY AND SAFETY OF THE PRODUCTS AND THE HEALTH OF THE PEOPLE WHO USE THESE LIFESAVING THERAPIES. AS A STANDARD-BEARER FOR THE INDUSTRY, PPTA HAS ESTABLISHED SEVERAL DIFFERENT QUALITY PROGRAMS TO PROMOTE QUALITY PRACTICES FROM VEIN TO VEIN, FROM DONOR TO PATIENT. THESE TWO PROGRAMS, THE INTERNATIONAL QUALITY PLASMA PROGRAM (IQPP) AND QSEAL (QUALITY STANDARDS OF EXCELLENCE, ASSURANCE AND LEADERSHIP) HAVE PROPELLED MEMBERS OF PPTA TO THE TOP OF THE BIOPHARMACEUTICAL INDUSTRY. THE STANDARDS WITHIN THESE TWO PROGRAMS COVER ALL AREAS THAT INFLUENCE THE QUALITY AND SAFETY OF SOURCE PLASMA - FROM COLLECTION TO TRANSPORTATION AND FROM STORAGE TO MANUFACTURING. THESE QUALITY PROGRAMS ARE DESIGNED TO SHAPE FUTURE NEEDS AND REQUIREMENTS AND TO ANTICIPATE THE RESOURCES NECESSARY TO ACCOMMODATE THEM. NEW VOLUNTARY STANDARD FOR INTERMEDIATES: PPTA HAS FINALIZED THE VOLUNTARY STANDARD FOR INTERMEDIATES. THE PURPOSE OF THIS STANDARD IS TO HAVE A COMMON UNDERSTANDING ABOUT THE ACCEPTANCE OF INTERMEDIATES IN THE MANUFACTURE OF PLASMA DERIVED THERAPIES. THIS STANDARD WILL CONTRIBUTE TO THE COMMITMENT OF PPTA MEMBERS TO PROVIDE THERAPIES OF THE HIGHEST QUALITY. THE STANDARD WAS REVISED TO ADDRESS IMPLEMENTATION DATES FOR INTERMEDIATES MADE FROM RECOVERED PLASMA. THE IMPLEMENTATION DATE FOR THE INTERMEDIATES STANDARD FOR INTERMEDIATES MADE FROM SOURCE PLASMA IS JULY 1, 2003. TECHNICAL CONSIDERATIONS FOR THE PERFORMANCE OF NUCLEIC ACID AMPLIFICATION TECHNOLOGY: THIS GUIDANCE HAS BEEN INCORPORATED INTO THE QSEAL AUDIT FOR ADHERENCE TO PPTA'S VOLUNTARY INDUSTRY STANDARD OF NAT TESTING FOR HIV, HBV, HCV AND PARVOVIRUS B19. QSEAL: PEOPLE AROUND THE WORLD DEPEND ON THERAPEUTICS DERIVED FROM HUMAN PLASMA TO TREAT CONDITIONS SUCH AS HEMOPHILIA, IMMUNE DISORDERS, AND OTHER DISEASES OR INJURIES. SAFETY OF PLASMA THERAPEUTICS IS THE TOP PRIORITY OF THE PLASMA FRACTIONATION INDUSTRY. THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION (PPTA), ON BEHALF OF ITS INDUSTRY MEMBERS, SUPPORTS EFFORTS BY REGULATORY BODIES TO ESTABLISH MINIMUM REQUIREMENTS TO ENSURE THE SAFETY OF THESE PRODUCTS. IN 1996, PPTA ADOPTED FOUR VOLUNTARY STANDARDS WHICH GO BEYOND REGULATORY REQUIREMENTS AND HELP DEFINE THE REGULATIONS AS THEY APPLY TO FRACTIONATION OF PLASMA FOR PLASMA THERAPEUTICS. THESE VOLUNTARY STANDARDS RELATE TO COLLECTING, PROCESSING, AND TESTING OF SOURCE PLASMA BY MEMBER FRACTIONATORS. IN 2000, PPTA ESTABLISHED THE QSEAL CERTIFICATION PROGRAM TO PROVIDE INDEPENDENT CERTIFICATION OF ADHERENCE BY FRACTIONATORS TO THE VOLUNTARY STANDARDS. IN 2001, THE FIRST FIVE PPTA MEMBERS TO RECEIVE THEIR CERTIFICATION WERE RECOGNIZED: ALPHA THERAPEUTIC BAYER BAXTER BIOSCIENCE BIOTEST AVENTIS BEHRING |
| FORM 990, PART XII | FORM 990, PART XII, LINE 2C THE AUDIT OVERSIGHT PROCESS HAS REMAINED UNCHANGED FROM THE PRIOR YEAR |
For Paperwork Reduction Act Notice, see the Instructions for Form 990 or 990-EZ.
Cat. No. 51056K
Schedule O (Form 990) 2021
Additional Data
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