| 00:00:01 | THANKS. |
| 00:00:02 | >>> THANK YOU, BRIAN, FOR YOUR INTRODUCTION, AND THANK YOU TO THE PARTNERSHIP FOR SAFE MEDICINES FOR INVITING ME TO JOIN YOU TODAY. |
| 00:00:10 | I HAVE TO SAY IT'S BEEN A GREAT DAY. |
| 00:00:13 | A DAY IN WHICH IT'S BEEN REALLY HEARTENING TO SEE THE LEVEL OF COOPERATION THAT THERE IS BETWEEN REGULATORS, LAW ENFORCERS, INDUSTRY, PATIENT GROUPS, AND SO ON. |
| 00:00:26 | FOR ME, ITS'S BEEN A PARTICULAR DELIGHT AND I WANT TO THANK AGAIN THE PARTNERSHIP FOR SAFE MEDICINE FOR AWARDING THE MHRA THE GUARDIAN AWARD FOR THE COMMITMENT THAT WE HAVE IN THE MHRA TO FIGHT COUNTERFEITS. |
| 00:00:42 | A COMMITMENT, OF COURSE, WHICH WE SHARE WITH ALL OF YOU HERE. |
| 00:00:51 | FOR THOSE OF YOU WHO DON'T KNOW, THE MHRA IS THE UK'S REGULATORY AGENCY FOR MEDICAL DEVICES AND FOR BLOOD. |
| 00:01:02 | NOW, OBJECTIVE IS REALLY SIMPLE. |
| 00:01:05 | THE MEDICINES AND MEDICAL DEVICES SHOULD WORK AND BE ACCEPTABLY SAFE, AND IT'S NO SURPRISE TO ANY OF YOU THAT THAT PRODUCT UNDERMINED THE CONFIDENCE PATIENTS HAVE IN THEIR MEDICINES. |
| 00:01:24 | WHAT I WANT TO DO REALLY BRIEFLY IS TO FOCUS ON WHAT THE THREAT IS GLOBALLY AND IN THE UK, AND THEN TO GO ON TO SAY SOMETHING VERY BRIEFLY ABOUT WHAT WE'RE DOING TO ADDRESS THAT THREAT. |
| 00:01:49 | THIS MAP OF THE WORLD IS BASED UPON A VERY BRIEF SURVEY OF THE FIRST FOUR MONTHS OF THIS YEAR. |
| 00:01:56 | AND PRESS REPORTS EASILY ACCESSIBLE PRESS REPORTS OF KNOWN COUNTERFEIT CASES. |
| 00:02:03 | SINCE I SUBMITTED THIS PRESENTATION, I HAVE UPDATED THIS AND YOU WOULD NEED TO ADD TO THIS MAP CANADA, INDIA, SOUTH AFRICA, AND EGYPT AND SOME 40 OR SO REPORTS FROM AROUND THE WORLD. |
| 00:02:17 | THIS, OUR GUESS IS, THE TIP OF THE ICEBERG. |
| 00:02:20 | AND IT'S CLEAR THAT FOR EVERY COUNTRY IN EVERY CONTINENT IN EVERY PART OF THIS WORLD IS SUBJECT TO THIS SAME THREAT OF COUNTERFEIT MEDICINES. |
| 00:02:32 | AND I'LL SKIP THE NEXT SLIDE WHICH GIVES SOME OF THE DETAIL. |
| 00:02:37 | THE UK EXPERIENCE THEN IS, AS WE HAVE SEEN SO MUCH TODAY ALREADY, THE VAST MAJORITY OF COUNTERFEITS ARE SUPPLIED THROUGH THE ILLEGITIMATE INTERNET SUPPLY CHAIN. |
| 00:02:49 | WE HAVE SEEN IN THE UK SOME TEN CASES IN EIGHT YEARS OF KNOWN COUNTERFEITS WITHIN THE LEGITIMATE SUPPLY CHAIN THAT HAVE REACHED PHARMACISTS AND THEREFORE POTENTIALLY REACHED PATIENTS. |
| 00:03:05 | BUT THAT'S IN THE CONTEXT OF APPROACHING 900 MILLION PRESCRIPTIONS THAT ARE WRITTEN EVERY YEAR IN THE UK. |
| 00:03:12 | SO THE CONCLUSION HAS TO BE THAT IT'S INCREDIBLY RARE WITHIN THE LEGITIMATE SUPPLY CHAIN IN THE UK TO FIND A COUNTERFEIT PRODUCT. |
| 00:03:22 | BUT NONETHELESS, IT'S STILL A THREAT, AND IT'S STILL ENTIRELY UNACCEPTABLE. |
| 00:03:27 | THE MAJOR RISKS WHICH AS I SAY WE'RE ALL AWARE OF, IS UNREGULATED SOURCES. |
| 00:03:34 | AND I THOUGHT SALLY GREENBERG, IS SHE STILL HERE? |
| 00:03:38 | SHE'S GONE. I THOUGHT HER ADVICE WHICH SHE TELLS ME IS TAKEN FROM HER WEBSITE ON HOW TO DEAL WITH INTERNET ONLINE PURCHASES WAS PROBABLY THE MOST CLEAR AND SUCCINCT ADVICE ON THAT SUBJECT I HAVE HEARD. |
| 00:03:57 | THIS SHOWS, THE RED BARS SHOW THE TEN CASES I REFERRED TO. |
| 00:04:02 | SHOWS THE NUMBER OF CASES THAT WE HAVE IDENTIFIED. |
| 00:04:05 | NOW, INTERESTINGLY ENOUGH, AND I HOPE THERE'S NO CORRELATION, THIS SURGE IN CASES COINCIDED WITH MY ARRIVAL AT THE MHRA AT THE BEGINNING OF 2005. |
| 00:04:17 | I DON'T THINK THERE'S ANY CORRELATION, BUT IN 2007, IT LED US TO PUBLISH OUR FIRST STRATEGY AS AN AGENCY. |
| 00:04:30 | WHAT I WOULD POINT OUT ON THIS SLIDE IS THAT THE COUNTERFEIT ARE NOT CONFINED TO LIFESTYLE PRODUCTS. |
| 00:04:38 | A NUMBER OF THESE COUNTERFEITS ARE LIFE-SAVING PRODUCTS. |
| 00:04:43 | USED FOR SERIOUS LIFE THREATENING CONDITIONS. |
| 00:04:49 | I THINK IT'S CLEAR TO ALL OF US THAT THERE IS NO SUCH THING AS A SAFE COUNTERFEIT. |
| 00:04:56 | AT EVERY STAGE, THE MANUFACTURE IS ALMOST CERTAINLY GOING TO BE OF POOR QUALITY. |
| 00:05:03 | THERE'S LIKELY TO BE CROSS CONTAMINATION OF THE PRODUCT. |
| 00:05:05 | THE INGREDIENTS WILL HAVE BEEN OBTAINED FROM THE WRONG SOURCES. |
| 00:05:09 | THEY MAY BE THE WRONG IDENTITY AND THEY'LL CERTAINLY BE THE WRONG QUANTITY. |
| 00:05:15 | IN CASES WHERE WE HAVE SEEN WHERE PATIENTS HAVE BEEN TREATED WITH UNDERPOTENT DRUGS FOR CANCER, UNDERPOTENT DRUGS FOR PSYCHOSIS, YOU CAN ONLY BEGIN TO IMAGINE THE CONSEQUENCE THAT MIGHT HAVE HAD, WHICH WOULD GO UNDETECTED, BY THE WAY, IN BOTH OF THOSE EXAMPLES, MOST PROBABLY. |
| 00:05:35 | CLEARLY, THERE WILL BE INPURITIES IN SUCH PRODUCTS. |
| 00:05:38 | THE CONSUMERS DESERVE TO BE CONFIDENT IN THEIR PRODUCTS THAT THEY'RE BUYING. |
| 00:05:44 | BUT NOT ONLY IS THAT A DIRECT RESULT OF A DAMAGE TO THE PUBLIC HEALTH, THERE'S ALSO DAMAGE TO INDUSTRY. |
| 00:05:52 | AND I THINK RALPH AND JOHN PROBABLY REFERRED TO THIS IN WHAT THEY SAID. |
| 00:05:58 | ONE OF THE CLEAREST ASSETS WHICH INDUSTRY HAS IS ITS REPUTATION. |
| 00:06:05 | AND THE PRESENCE OF EVEN SMALL AMOUNTS OF COUNTERFEIT PRODUCTS IN THE MARKET THREATENS TO DAMAGE THAT REPUTATION BECAUSE ALMOST CERTAINLY, YOU HAVE TO RECALL THE AUTHENTIC PRODUCTS THAT ARE INDISTINGUISHABLE FROM THE COUNTERFEITS AT THE SAME TIME, AND THEREFORE DAMAGES AN INDUSTRY'S REPUTATION. |
| 00:06:24 | WHAT IS BEING DONE? |
| 00:06:26 | IN EUROPE, WE HAVE NOW ENACTED A FALSIFIED MEDICINES DIRECTIVE, AND THAT'S IN THE PROCESS OF THE NEXT YEAR OR SO OF BEING IMPLEMENTED. |
| 00:06:36 | MAJOR INITIATIVE, AND A LOT OF ITS CONTENT WAS ACTUALLY INFLUENCED BY THE REVIEW THAT THE UK UNDERTOOK IN ITS KNOWN CASES OF COUNTERFEITS. |
| 00:06:48 | BRIEFLY TO INTRODUCE YOU TO THIS IF YOU'RE NOT FAMILIAR WITH IT, FOUR MAIN COMPONENTS, SAFETY FEATURES IS THE FIRST COMPONENT. |
| 00:06:55 | AND THIS IS WHAT IS CALLED IN EUROPEAN LAW, A DELEGATED ACT WHICH MEANS THAT THE PRECISE DETAILS AND EVEN THE TIMING IS YET TO BE DETERMINED. |
| 00:07:04 | BUT IT CLEARLY HAS TWO COMPONENTS. |
| 00:07:06 | THE FIRST IS THAT OF TAMPER EVIDENT FEATURES AND THE OTHER IS OF PACK AND SPECIFIC IDENTIFICATION. |
| 00:07:17 | AND THE EXTICATEENT OF BOTH OF THESE COMPONENTS IS YET TO BE DETERMINED. |
| 00:07:23 | WILL IT BE SOME PRODUCTS OR ALL PRODUCTS AND WHAT WILL BE THE NATURE OF THE SECURITY FEATURES? |
| 00:07:29 | MOVING ON, OTHER FACTORS IN THE SUPPLY CHAIN, UNTIL NOW, BROKERS, THESE FOLKS WHO ACTUALLY MANAGED THE DEALS BUT NEVER ACTUALLY PHYSICALLY HANDLED THE PRODUCTS, HAVE BEEN OUTSIDE OF REGULATION. |
| 00:07:40 | THEY WILL BE BROUGHT WITHIN REGULATION. |
| 00:07:43 | AND ALSO, THOSE PEOPLE WHO WE HAVE ALREADY REFERRED TO IT TODAY, IMPORT A PRODUCT INTO A COUNTRY, NOT TO MARKET IT WITHIN THAT COUNTRY, BUT ACTUALLY TO SHIP IT ON TO ANOTHER COUNTRY. |
| 00:07:54 | AND OFTEN ADD SOME LEVEL OF LEGITIMACY TO THEIR PRODUCT BY DOING THAT. |
| 00:07:59 | THEY, TOO, WILL COME WITHIN LEGISLATION. |
| 00:08:02 | AND I SHOW THIS SLIDE. |
| 00:08:04 | WE HAVE REFERRED TO THIS. |
| 00:08:05 | THIS WAS A CASE IN POINT WHERE OUR PRODUCT WAS ROOTED THROUGH THE UK WITH A FUTURE GOING ON TO THE U. |
| 00:08:15 | S. THE THIRD COMPONENT IS A MOVE TO FIND A WAY OF -- AND AGAIN, THIS IS YET TO BE DETERMINED HOW, TO FIND A WAY OF BETTER RECOGNIZING LEGITIMATE PHARMACIES THAT OPERATE ON THE INTERNET, AND THE FINAL COMPONENT CONCERNS ACTIVE PHARMACEUTICAL INGREDIENTS. |
| 00:08:35 | CLEARLY, THIS WAS A LARGELY DRIVEN BY THE TRAGIC INCIDENT SURROUNDING HEPARIN, AND IT PROVIDES SAFE GUARDS AND ASSURANCES REGARDING THE QUALITY OF THE API. |
| 00:08:51 | MOVING ON TO ANOTHER INITIATIVE WITHIN EUROPE, THIS IS ACTUALLY A COUNCIL OF EUROPE MISHINITIATIVE. |
| 00:09:02 | THE EUROPEAN UNION HAS 27 MEMBER STATES. |
| 00:09:05 | THE COUNCIL OF EUROPE HAS 47 MEMBER STATES. |
| 00:09:08 | AND MUCH BROADER, INCLUDES SUCH PLACES AS RUSSIA WITHIN ITS NUMBER. |
| 00:09:15 | AND THE COUNCIL OF EUROPE PUT TOGETHER A MEDI CRIME CONVENTION WHICH HAS A NUMBER OF KEY COMPONENTS. |
| 00:09:24 | FIRSTLY, TO MAKE SURE THAT COUNTERFEITING IS PROPERLY CRIMINALIZED, TO SEEK TO PROTECT VICTIMS, AND TO PROMOTE COOPERATION BETWEEN THE 47 NATIONS. |
| 00:09:36 | IT REQUIRES CERTAIN LAWS TO BE IN PLACE. |
| 00:09:39 | IT REQUIRES THE EXCHANGE OF INFORMATION AND COOPERATION. |
| 00:09:43 | AND IT ALSO REQUIRES TRAINING. |
| 00:09:46 | THE UK HOSTED JUST EARLIER THIS YEAR TRAINING FOR POLICE, CUSTOMS, AND REGULATORS FROM A NUMBER OF EASTERN EUROPEAN COUNTRIES IN LONDON. |
| 00:09:57 | A VERY SUCCESSFUL TRAINING WEEK DRIVEN BY THIS PARTICULAR CONVENTION. |
| 00:10:04 | WITHIN THE UK, I MENTIONED WE HAD OUR FIRST STRATEGY FOR COUNTERFEIT MEDICINES BACK IN 2007. |
| 00:10:12 | WE HAVE JUST REFRESHED THAT AND A NEW STRATEGY HAS BEEN ISSUED THIS YEAR. |
| 00:10:16 | I WOULD COMMEND IT TO YOU IF YOU HAVE TIME TO LOOK ON OUR WEBSITE. |
| 00:10:22 | THE KEY OBJECTIVES OF THAT STRATEGY ARE STRAIGHTFORWARD. |
| 00:10:26 | ONE IS TO REDUCE THE RISK TO PATIENTS AND CONSUMERS FROM COUNTERFEIT PRODUCTS AND PERHAPS EQUALLY IMPORTANT, THE OBJECTIVE OF INCREASING THE RISK FOR THOSE WHO ENGAGE IN THIS CRIMINAL ACTIVITY. |
| 00:10:42 | BECAUSE OF TIME, I'LL MOVE ON VERY QUICKLY, BUT THERE ARE THREE MAIN COMPONENTS, THAT OF PROTECTION AND KEY AMONGST PROTECTION IS PUBLIC AWARENESS. |
| 00:10:53 | THAT'S FROM THE BIGGEST PANEL OF SPEECHES. |
| 00:10:56 | WE HAVE WORKED HARD IN A NUMBER OF WAYS. |
| 00:11:00 | A VERY SUCCESSFUL CAMPAIGN WITH A NUMBER OF FOLKS HERE WITH FISA, AND A PRESCRIPTION CAMPAIGN. |
| 00:11:10 | SOME OF YOU WILL HAVE SEEN IT. |
| 00:11:12 | IF YOU HAVEN'T, I GUESS IF YOU PROBABLY LOOK IT UP IN YOUTUBE, IT WILL APPEAR. |
| 00:11:18 | A VERY SUCCESSFUL CAMPAIGN REACHED MILLIONS OF FOLK WITHIN THE UK. |
| 00:11:25 | WE ALSO WITH OUR PHARMACEUTICAL SOCIETY, PLACED ATTRACTIVE LEAFLETS WITHIN PRESCRIPTIONS. |
| 00:11:31 | A NUMBER OF OTHER AREAS, COLLABORATION WITH STAKEHOLDERS WHICH HAS ENABLED US TO ACTUALLY COME UP WITH A CLEAR WATCH LIST OF PRODUCTS THAT SHOULD BE SUBJECT TO SURVEILLANCE AND TESTING. |
| 00:11:45 | THE SECOND ITEM IS INCIDENT MANAGEMENT. |
| 00:11:47 | THE KEY PRIORITY IS TO REMOVE DANGEROUS PRODUCTS FROM THE MARKET, TO QUARANTINE OR SEIZE THOSE PRODUCTS. |
| 00:11:55 | HAVING DONE THAT, TO SET UP A TEAM WHICH IS CHAIRED AT A SENIOR LEVEL IN THE AGENCY, WHICH DRIVES THE TESTING, THE RECALL, THE MEDIA ALERTS AND SO ON. |
| 00:12:09 | AND FINALLY, INVESTIGATION AND PROSECUTION OF THE COUNTERFEITERS. |
| 00:12:15 | LOOKING FOR CUSTODIAL SENTENCES WHERE THERE IS CRIME THAT HAS BEEN PROVED. |
| 00:12:22 | SEEKING TO GAIN FINANCIAL RECOVERY OF ILL-GOTTEN GAINS FROM THESE CRIMINALS. |
| 00:12:31 | WE HAVE MENTIONED PANGAEA AND THE INTERNET CAMPAIGN. |
| 00:12:35 | THIS YEAR, IT WILL HAVE INVOLVED OVER 90 DIFFERENT NATIONS WORLDWIDE. |
| 00:12:46 | I WON'T GO INTO ANY DETAIL, BUT WE SEEK TO USE ALL OF THE MEANS POSSIBLE TO ACTUALLY INCREASE AWARENESS AMONGST THE PUBLIC. |
| 00:12:58 | WE HAVE HAD SOME GRATIFYING SUCCESS. |
| 00:13:03 | CONVICTIONS, SEIZURES OF PROCEEDS AND SO ON. |
| 00:13:07 | IN CONCLUSION, AND FINALLY, WE CAN'T BE COMPLACENT. |
| 00:13:11 | NO SUPPLY CHAIN IS IMPENETRABLE. |
| 00:13:15 | AND THE SECRET OF SUCCESS HAS TO BE -- THE SECRET OF SUCCESS HAS TO BE COOPERATION. |
| 00:13:23 | WE HEARD MORE ABOUT THAT WITH THE OVERARCHING AIM THAT WE ALL SHARE TO MAKE SURE THAT OUR PUBLIC IS SAFE. |
| 00:13:30 | AND OUR CITIZENS ARE SAFE FROM FALSIFIED AND POTENTIALLY DANGEROUS MEDICINES. |
| 00:13:36 | SO THANK YOU FOR YOUR ATTENTION. |
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