RECORD OF DISCUSSIONS. CANADIAN ADVERTISING PRECLEARANCE AGENCIES and HEALTH CANADA

Transcription

1 RECORD OF DISCUSSIONS CANADIAN ADVERTISING PRECLEARANCE AGENCIES and HEALTH CANADA Jeanne Mance Building, 200 Eglantine Driveway, Ottawa, Rm 836 D Tuesday April 18, :00 a.m. 12:30 p.m. Discussins f Health Prduct Advertising Issues and Tpics f Mutual Interest t Canadian Advertising Preclearance Agencies and Health Canada N plicy decisins are made at these meetings. The fllwing is a summary f the discussins between participants. Canadian Advertising Preclearance Agencies Participants Advertising Standards Canada (ASC): Jani Yates, CEO & President Nicle Bellam, Vice-President, ASC Clearance Services Ruta Rzentals, Senir Analyst, ASC Clearance Services Extreme Reach Canada: Anna Haine, Directr, Clearance and Verificatin Services Pharmaceutical Advertising Advisry Bard (PAAB): Ray Chepesiuk, Cmmissiner Patrick Massad, Deputy Cmmissiner Dr. Walter Rsser, Chair f PAAB Bard Health Canada Participants Marketed Health Prducts Directrate (MHPD): Jhn Patrick Stewart, Directr General (Chair) Lisa Lange, Directr, Therapeutic Effectiveness and Plicy Bureau Alain Musende, Manager, Regulatry Advertising Sectin (RAS)

2 Christphe Ry, Senir Regulatry Plicy and Risk Management Advisr, RAS Rim Lejmi-Mrad, Senir Regulatry Plicy and Risk Management Advisr, RAS Arshia Bhatti, Regulatry Plicy and Risk Management Officer, RAS Natural and Nn-prescriptin Health Prducts Directrate (NNHPD): Mann Bmbardier, Directr General, NNHPD Matthew Bwn, Senir Analyst, CHPM, NNHPD Nana Bafi-Yeba, Manager, BPRA, NNHPD Regulatry Operatins and Regins Branch (RORB): Cllin Pint, Manager, RORB Stephanie Di Trapani, Manager, RORB Mimi Lin, Senir Crprate Regulatry Cmpliance & Enfrcement Advisr, RORB Kira Kaminsky, Crprate Regulatry Cmpliance & Enfrcement Advisr, RORB Office f Medical Cannabis (OMC): David Pellmann, Executive Directr, OMC Chris Rse, Directr, OMC Benit Seguin, Manager, Cmpliance and Enfrcement, OMC Sarah Wright-Gilbert, Stakehlder Relatins Liaisn, OMC Healthy Envirnments and Cnsumer Safety Branch (HECSB): Denis Chiniere, Directr, TPRO, HECSB 1. Opening Remarks & Self-Intrductins The Chair, Jhn Patrick Stewart intrduced himself and welcmed Health Canada members and the Advertising Preclearance Agencies (APAs). He infrmed the participants that the 2017 bilateral meeting wuld fllw a different frmat cmpared t previus years. The new frmat wuld fcus n sharing trends and issues f interests that Health Canada and the APAs have identified during the year. This year s meeting wuld als include data n all cmplaints received and handled by Health Canada and nt just MHPD. 2. Perfrmance Reprt and Key Advertising Issues Page 2 f 7

3 Issue: Health Canada and APAs presented n trends and issues f interests that they have identified during the year, in additin t statistical reprt f advertising cmplaints activities. Discussin Highlights: Health Canada: Health Canada discussed: Advertising cmplaints handled by Health Canada MHPD s vigilance & preventin activities Key advertising trends & issues f interest Cnsistency n regulatry advertising versight appraches acrss Health Canada s prduct types Advertising cmplaints handled by Health Canada: During its previus fiscal year, 63% f the cmplaints handled by Health Canada invlved natural health prducts while 32% were n prescriptin drugs, 3% n bilgics (including vaccines) and 2% n medical devices. Fr NHPs, cmplaints invlved Schedule A claims, unauthrized prducts, as well as authrized NHPs where APAs culd nt achieve wilful cmpliance. The majrity f cmplaints invlved advertising via Web sites and Scial Media. MHPD s vigilance & preventin activities: Review f Advertising Advisry Opinins remains the predminant activity carried ut by MHPD, accunting fr 54% f its actins pertaining t advertising issues. Key trends and issues f interest invlved: Advertising f Human Chrinic Gnadtrpin (hcg) fr weight lss use, which is an ff-label indicatin, by clinic Web sites acrss Canada. Health Canada issued an Infrmatin Update and a ntice in the Health Prduct InfWatch n this issue and infrmed prvincial and territrial clleges f physicians and surgens; as well as naturpaths and pharmacist assciatins Opiid Crisis Health Canada is explring the ptin f mandatry preclearance fr piid advertising materials directed t healthcare prfessinals. Impacted stakehlders will be cnsulted, shuld this initiative is t be implemented Advertising f bisimilars Health Canada has received cmplaints in relatin t advertising f bisimilars. This may be trend-setting as mre bisimilar prducts will be made available in the cming years. Onging discussins with APAs and ther stakehlders are nging t ensure clarity and cnsistency Medical Device (MD) Advertising Inclusin f MD guidelines in the Cnsumer Advertising Guidelines fr Marketed Health Prducts (CAG) in cllabratin with ASC. Health Canada and ASC carried ut 3 webinars t infrm stakehlders and clarify the scpe f the initiative (apprximately 1,000 stakehlders attended) Page 3 f 7

4 MHPD is leading cllabrative wrk with Health Canada partners t ensure cnsistency n the regulatry advertising versight between standard prduct types and new nes, such as Vaping Prducts (e-cigarettes) and Medical Cannabis Advertising Standards Canada: Administers the Canadian Cde f Advertising Standards and engages in advertising preclearance in 5 regulated areas. In 2016, ASC received a ttal f 1639 cmplaints with the majrity assciated with televisin advertisement. In terms f marketed health prducts: ASC received a ttal f 9 cmplaints The majrity invlved natural health prducts Eighty percent (80%) f cmplaints were reslved within 4-8 weeks Pharmaceutical Advertising Advisry Bard: The PAAB bard is cmprised f: Pharmaceutical trade assciatins Healthcare prfessinal rganizatins Patient grups Medical publishers Medical advertisers In 2016, PAAB carried ut: 7535 first preclearance reviews Average respnse time f 6.4 days The majrity f the ads is intended t healthcare prfessinals and invlved Paper- Detail Aid The PAAB handled a ttal f 4 stage II cmplaints (reassessment by PAAB Cmmissiner). Key upcming activities f the PAAB are training wrkshps in Mntreal and Trnt. Extreme Reach: Primary Service fferings include: Televisin & Radi Ad Delivery Bradcast Clearance Digital Ad Serving & Analytics Regulated categries include: NHPs Fd/Beverages Csmetics Alchl Page 4 f 7

5 Extreme Reach bserved an increased spending n NHP advertising vs ther categries. Actin: N/A 3. Mdernizing the Regulatin f Self-Care Prducts (SCPs) Issue: Self-care prducts are cmprised f csmetics, NHPs, and nn-prescriptin drugs. Althugh all SCPs are regulated under the Fd & Drugs Act, they are subject t: Different rules fr hw t bring prducts t market Different levels f evidence required fr health claims Different levels f pst-market mnitring and cmpliance enfrcement Discussin Highlights: Health Canada is prpsing: Self-care prducts t be regulated accrding t the level f risk they pse t cnsumers Prducts making similar claims wuld require similar evidence Health Canada t have apprpriate pwers t address safety cncerns and nncmpliance Health Canada believes this apprach wuld benefit cnsumers & industry in terms f: Cntinued access t a wide range f safe & effective SCPs Better infrmatin t supprt infrmed decisin-making Mre predictable and cnsistent rules fr bringing prducts t market Risk-based rules that d nt impse unnecessary regulatry burden Health Canada has scheduled a new series f cnsultatins with Canadians acrss the cuntry. Questins frm participants fcused n: Impact f this new framewrk n health prduct advertising Opprtunity fr external stakehlders t cmment n the framewrk. Sme APAs indicated that they have attended previus cnsultatins n this framewrk Actin: N/A 4. Medical Cannabis Framewrk Page 5 f 7

6 Issue: The purpse f the presentatin was t discuss access t cannabis fr medical purpses with APAs and Health Canada stakehlders. Discussin Highlights: The Access t Cannabis fr Medical Purpses Regulatins (ACMPR) were intrduced n August 24, 2016, t prvide Canadians with access t cannabis fr medical purpses with the authrizatin f their healthcare practitiner. Patients purchase quality-cntrlled cannabis frm a licensed prducer (LP), r register with Health Canada t prduce a limited amunt fr their wn medical purpses; r, designate smene t prduce it fr them. Bth dried Marijuana and Cannabis il are present in the Canadian market. Licensed prducers may be licensed t prduce and sell dried and fresh marijuana, cannabis il, and starting materials (seeds and plants) t registered patients. Frty tw prducers have been licensed and their list is n Health Canada s website 1. Cannabis is a cntrlled substance, narctic, and drug. As such, its advertising is regulated under the Fd and Drugs Act and the Narctic Cntrl Regulatins. Althugh the NCR prhibits any advertising fr cannabis t the public, Licensed Prducers are permitted t prvide t the public representatins f the brand name, prper r cmmn name f the strain, price, cannabinid cntent and cntact infrmatin as it assists patients in making an infrmed decisin. Hwever, therapeutic claims and prmtinal wrding have been detected in these ads. Cnsequently, Warning and Cmpliance prmtin letters are issued t LPs utlining advertising prhibitins. Actin: APAs will be kept infrmed n the prgress and will be cnsulted fr cmments and feedback. 5. Amendments t the Tbacc Act, Nn-Smkers Health Act, and ther Acts Issue: The purpse f the presentatin was t discuss a new legislative/regulatry framewrk t address the ptential benefits and risks f vaping prducts. Discussin Highlights: 1 Page 6 f 7

7 The discussin fcused n the fact that a new legislative framewrk was needed because the current federal legislative/regulatry framewrk did nt address all f the ptential benefits and risks f vaping prducts. The Gvernment cmmitted t intrducing legislatin that wuld include measures t prtect yuth frm nictine addictin and inducement t tbacc use while allwing adults t legally access vaping prducts as a likely less harmful alternative t tbacc; and prtect Canadians frm dangers t health r safety. The new Bill cntains a number f prvisins prhibiting certain types f prmtinal activities, including: Fr flavurs that culd be appealing t yung persns Lifestyle advertising and advertising appealing t yuth Spnsrship prmtin Endrsements Giveaways Pr-tbacc use prmtin (e.g., dn t quit just switch ) False and misleading prmtin Crss branding with tbacc prducts These restrictins wuld be similar, but nt as restrictive as thse fr tbacc prducts. Actin: N/A. 6. Clsing Remarks Health Canada thanked participants fr the valuable discussin and input. Participants were reminded that a recrd f discussins wuld be available fr cmment and the APAs were encuraged t share this dcument with their members since it is n lnger psted n Health Canada s Web site. Lisa Lange, Directr, Therapeutic Effectiveness and Plicy Bureau Marketed Health Prducts Directrate Page 7 f 7