ASOP Global Illegal Online Drug Sales Research Symposium
Washington, D.C., USA
November 14, 2018 – Save the Date
October 18, 2018
Join us for our advocacy day in Ottawa on October 18th! Plan for a day involving a breakfast briefing session with MPs followed by meetings around Ottawa with elected officials, bureaucrats and staff. A briefing call will be scheduled in late September, more information to follow.
Seoul, Republic of Korea
August 28 – 30, 2018
Program for the upcoming 2018 APEC Harmonizing Center Global Supply Chain Integrity Training in Seoul, Republic of Korea.
June 26, 2018
The manufacture and distribution of fake medicines is an enormous and growing public health risk with an untold cost to lives. Vast profits are made by organized criminal gangs who will use the proceeds to support other criminal activities. Evidence shows that consumers and patients are becoming increasingly reliant on, and trusting of, the Internet, which also provides the channel to buy illegally distributed fake medicines, in the majority of cases by an unaware public.
On 26 June 2018, EU policymakers and stakeholders met in the European Parliament to raise awareness on Internet sales of medicines and help enhance patient safety. The event, titled “How safe are your medicines? Raising public awareness is critical to Internet patient safety”, was jointly organised by the Alliance for Safe Online Pharmacy in the EU (ASOP EU) and MEP José Inácio Faria (EPP, Portugal).
As shown in a recent ASOP EU research study, up to 65% of people going online to buy a medicine do so without prior knowledge of the fact that 96% of websites selling medicines are operating illegally. This market is a global one with the Internet allowing a rapid and seamless buying of a medicine. Education is a key success factor in solving this patient safety problem, emphasised Professor Mario Frota, President of the Associação Portuguesa de Direito do Consumo – the Portuguese Association of Consumer Law (APDC) said “We are far from a situation where consumers are adequately informed, and therefore, comprehensive information campaigns are necessary as ignorance is the biggest threat to public health.”
“The Falsified Medicines Directive (FMD) is an important instrument to protect European citizens from falsified medicines; it covers a range of measures aimed at preventing falsified medicines entering the supply chain, including obligatory safety features on the packs, improved inspections and better controls of intermediate steps in the supply chain. In addition, the FMD requires that any website selling a medicine must be registered and display a Common EU-wide Logo. This is a very positive step but at the same time the public needs to know about the Common Logo’s purpose and be informed about the risks of buying medicines online from illegal sources”, stated Ms Ilaria Passarani, Secretary General of the Pharmaceutical Group of the European Union (PGEU).
Article 85C and 85D of the FMD legally obliges the European Commission and each Member State to actively publicise the meaning of the Common Logo and that of a falsified medicine. The meeting was designed to focus on this fact and to find how Member States and the Commission should address this. At this moment, these articles are being implemented with variable consistency across Europe, as MEP Faria pointed out in his initial remarks.
There are up to 35,000 illegally operating websites that target consumers and patients across Europe. Fake medicines may have too much, too little or a different active ingredient, may contain poisons, paint thinners and other potential harmful or deadly ingredients. They can also be made in unsanitary or non-sterile environments with unsafe conditions.
MEP Marisa Matias (GUE/NGL, Portugal), rapporteur of the Falsified Medicines Directive, gave her full support to the issue of the safe distribution of medicines and highlighted how cooperation between different parliamentary groups has been critical to put in place the FMD and thus enhance the security around the traditional routes of medicines supply. MEP Matias also stressed the need to exert further pressure and act more forcefully to make people and all authorities more committed and sensitive to the problem of falsified medicines.
Mr Paulo Morais, President of Frente Civica, pointed out that Portugal ranks highly among EU Member States for counterfeit goods and therefore greater transparency needs to be applied and involve all stakeholders. This along with public facing campaigns and capacity building will be critical success factors in solving this worldwide problem.
The debate was also enriched by the contribution of Mr Tamás Király, Policy Officer for international aspects of intellectual property rights at the Directorate General for Trade of the Commission, who outlined the main elements of a new Watch List initiative, aimed to identify the marketplaces outside the EU where counterfeiting, piracy or other forms of intellectual property abuse are common practice. Its main priority is to protect EU business and consumers (including the fight against online sales of counterfeit/falsified medicines which cause patient harm) and also aims to urge Internet companies (including all Intermediaries such as registries, registrars, Internet Service Providers, search engines and platforms, etc.) to address this criminal activity.
Yuliya Morenets, Executive Director of Together against Cybercrime International (TaC), explained how a new initiative designed to educate the youth of today about falsified medicines was being developed. ASOP EU having signed an MoU with TaC will work together to achieve this.
Delivering training and capacity building to young people and engaging with them to promote their active participation will mean that young people who are active on the Internet can learn about online patient safety and disseminate this through their social media networks.
In conclusion, Mike Isles, ASOP EU Director, said that “We applaud our partners’ commitment to raising awareness about the dangers of buying medicines online. However, much more needs to be done and more activity by the Commission and Member States with their own campaigns is needed to build on the many initiatives across the EU to combat this growing threat to public health”.
It is therefore decisive to develop an integrated, comprehensive approach and strengthen coordination with EU and national competent authorities to spread the problem and share best practices, ensuring citizens the safety of care they deserve.
Denver, CO, USA
May 5, 2018
The Alliance for Safe Online Pharmacies (ASOP Global and ASOP Canada), together with the National Association of Boards of Pharmacy (NABP) and Canada’s National Association of Pharmacy Regulatory Authorities (NAPRA) organized an International Pharmacy Regulator Roundtable at the NABP’s Annual Conference, Denver Colorado on May 5, 2018.
The Roundtable served as a follow up to ASOP-NABP roundtable meetings in 2017. Representatives from ASOP, ASOP Canada, NABP and NAPRA were represented, along with provincial registrars, state Board of Pharmacy representatives, and the U.S. Food and Drug Administration.
provided a forum for participants to share updates regarding their respective activities and discuss ideas for greater international collaboration to address illegal online drug sellers. Roundtable participants identified opportunities for further collaboration, including: developing strategies in response to the findings from ASOP Canada’s consumer research survey; profiling policy and enforcement gaps and solutions at international, federal and regional levels; international pharmacy regulator coordination; and building ASOP Canada membership and stakeholder engagement.
April 17, 2018
According to the Alliance of Safe Online Pharmacy in the EU (ASOP EU) the illegal manufacturing and distribution of fake medicines is an enormous and growing public health risk with an untold cost to lives. Organised criminal gangs make vast profits from these illegal sales and often use the proceeds to support other sinister criminal activities.
The Internet provides the ideal channel to buy illegally distributed fake medicines. Price, convenience and secrecy as well as ignorance to the dangers are driving consumer demand, creating the perfect environment for over 35,000 illegally operating websites.
“The only really effective way to stop the criminals is by educating the public about buying medicines online. Our study shows that the vast majority of people just do not understand that most websites are selling medicines illegally. So if we can educate and stop the demand that is the more than half the battle won, ” said Mike Isles, Executive Director of ASOP EU.
Announced at the European Union Intellectual Property Office (EUIPO) Observatory meeting in Brussels, ASOP EU and Together against Cybercrime International (TaC) have teamed up to educate the youth of today about fake medicines by developing the Youth IGF Movement.
What is the Youth IGF Movement?
The Youth Internet Governance Forum (IGF) is a global movement that operates as a multi-stakeholder platform. It allows young people ages 15-29 years old to discuss and take a lead on issues related to Internet governance in the format of local, national or regional debates. These debates are organised by the young on a volunteer basis. The Youth IGF is based on the principles of the United Nations IGF.
The main objective of the initiative is to allow the voice of young people to be heard by Information Society leaders on issues related to internet governance and to help young people to take an active part in the decision-making processes.
Specific objectives include; promoting informal education on questions related to Internet governance and cybersecurity, raise awareness on Internet-related issues, safe and responsible use of the Internet and to promote the multi-stakeholder model among youngsters/ Promote entrepreneurship
“The phenomenon of fake medicines has massive consequences for the youth of today. With a growing expectation that the Internet enables you to buy literally anything online, then fake, falsified or substandard medicines causes real patient safety issues. Already we have cases of young girls buying slimming pills and overdosing and dying, which is a real tragedy. This collaboration can help educate the youth around the globe of today to ensure they have a safe future tomorrow,” said Yuliya Morenets, Founder of TaC.
Together against Cybercrime International (Tac) is a nonprofit civil society anti-cybercrime organisation established in France and working at local, national, European and international levels. TaC International works in the field of cybercrime/cybersecurity and child online protection and advises different entities on cybersecurity strategies. TaC is also actively involved in Internet governance issues by stimulating discussion on the use of information and communication technologies (ICTs) by vulnerable people and initiating debate in the format of youth and teenager dialogue. Website Facebook
March 8, 2018
ASOP EU recently convened an “All-Hands” Meeting with Members to discuss its 2018 objectives and share highlights of patient safety activities.
Of particular significance was the collaboration shown by key Members, notably Becton Dickinson, Clinigen, Fight the Fakes, FMEDS, GS1, MHRA and Sanofi, who took the opportunity to give details of their own initiatives against falsified medicines as well as endorsing the ASOP EU 2018 goals.
The key ASOP EU 2018 goals are:
December 4-8, 2017
ASOP Global completed a highly successful trip to China during the week of December 4, 2017. This trip was a follow-up to an October 2016 China trip – ASOP Global’s first activity in the country – that included a symposium organized by ASOP Global and local China partners titled “International Symposium on Drug Chain Security & Combating Counterfeit Drugs.”
The December 2017 follow-up trip provided an opportunity for ASOP Global to continue to build support in China for ASOP Global and patient safety regarding online sales of medicines. The ASOP Global Delegation included the following ASOP Global Board, member and observer organization representatives:
During the delegation trip, ASOP Global met with 11 organizations, listed below. These meetings included an excellent exchange of information and best practices with strong support expressed for ASOP Global’s efforts.
The delegation trip was very successful and ASOP Global is now viewed as a valuable partner as China moves forward with the sale of medicines online. China FDA is very interested in future coordination with ASOP Global, as well as Alibaba Health having viewed the organization as a valuable partner.
ASOP Global looks forward to continuing an open dialogue and cooperative efforts with organizations and other key China stakeholders in 2018 and beyond.
Below are pictures of the ASOP Global delegation meeting with China partners, China FDA and industry associations based in China.
November 21, 2017
The official membership signing took place during the First European Medical Association Annual Conference.
Mike Isles was invited to attend the General Assembly of the European Medical Association (EMA) by the President Vincenzo Costigliola. Mike was also given the opportunity to present the aims and objectives of the two organisations to the audience present.
The General Assembly took place within the Acute and General Medicine Congress which hosted the first European Medical Association Annual Conference.
The European Medical Association was created in 1990 by doctors from 12 member states, and was established as an “international foundation pursuing a scientific aim” according to the Belgian law dating 25/10/1919. It is a unique, independent non-profit organisation, which offers every European Community doctor the opportunity to: join a European network of doctors, add a European dimension to their professional and social life and actively influence the development of European healthcare.
In terms of collaboration with ASOP EU and the EAASM, plans are under way. As an example, an educational leaflet for patients informing them about the dangers associated with falsified medicines is being progressed. This has the potential to be effective in raising awareness across the EMA network and thus enhance patient safety greatly. In addition, EMA website visitors can click on an icon which routes through to an education website in 5 languages about falsified medicines. This website mirrors those that are currently part of the extensive Google AdWord campaigns running in France, Germany, Italy, Spain and the UK.
ASOP Global Delegation to China
December 4, 2017
As a follow-up to ASOP Global’s “International Symposium on Drug Supply Chain Security and Combatting Counterfeit Drugs” in October 2016, a delegation of ASOP Global Members returned to China on Monday, December 4. Led by Board Member Jeff Gren, the delegation began a slate of meetings with several key stakeholders in Beijing. The delegation, which includes representatives from the Pharmaceutical Security Institute, USP, UK Medicines & Healthcare products Regulatory Agency (MHRA), Takeda Pharmaceuticals, Rx-360 China, and Eli Lilly, met with representatives from PhIRDA, the U.S. Embassy, and the U.S. Food & Drug Administration China Office. Additional meetings are to be held over the next week – ten in total – with other key local and international partners in support of ASOP Global’s efforts to ensure patient safety and security online.
November 18, 2017
ASOP attended the 10th European Antibiotic Awareness Day organized by the European Centre for Disease Prevention and Control (ECDC). Mike Isles took the opportunity to meet the European Commissioner for Health, Dr. Vytenis Andriukaitis, who gave the keynote address, to inform him that consumers/patients who were buying antibiotics from illegally operating websites were potentially contributing to antimicrobial resistance (AMR).
Organizations were invited to say how they were contributing to the collaborative effort to combat AMR. ASOP explained how they were doing this with an intervention, as follows:
“The Alliance for Safe Online Pharmacy in the EU (ASOP EU) and its partner ASOP Global and these organizations are making the public aware of illegally operating online pharmacy websites. A recent report issued in March 2017 by the National Association of Boards of Pharmacy (a non-profit organization comprised of state pharmacy regulators in the US, Canada, Australia, New Zealand and other countries) revealed that two-thirds of organic search engine results for antibiotics, yielded rogue websites that sell these medications without the need for a prescription, operating in opposition to national and local laws and relevant pharmacy practice standards. Purchasing antibiotics from these websites means consumers are taking these powerful medications without oversight from a licensed health care provider and potentially contributing to antibiotic resistance.”
This is of major public health concern and highlights the need to educate patients and caregivers about how the overuse of antibiotics from illegal online pharmacies is leading to antibiotic resistance. ASOP has a number of initiatives to raise awareness, namely:
Combined resistance to multiple antibiotics: a growing problem in the EU
It is an alarming fact that AMR presents a serious social and economic burden. It is estimated to be responsible for 25,000 deaths per year in Europe and 700,000 deaths per year globally. AMR also pushes up the cost of treatment and diminishes productivity due to illness. In the EU alone, it is estimated that it cost EUR 1.5 billion annually. AMR threatens the achievement of several of the United Nation’s Sustainable Development Goals, particularly for the targets for good health and well-being.
In the ECDC policy-briefing, note their headline is telling and of great concern “Last-line antibiotics are failing: options to address this urgent threat to patients and healthcare systems.
Summary of the latest data on antibiotic resistance in the European Union makes for interesting reading and highlights the various areas of Europe being affected by AMR. It highlights that prudent antimicrobial use and comprehensive infection prevention and control strategies targeting all healthcare sectors are the cornerstones of effective intervention to prevent the selection and transmission of bacteria resistant to antimicrobial agents.
Read the press release here: Combined resistance to multiple antibiotics: a growing problem in the EU
Fight the Fakes International Meeting
October 23-25, 2017
ASOP Global’s Mike Isles was among the Fight the Fakes partners representing healthcare professionals, academia, NGOs, the generic and research-based pharmaceutical industry, healthcare distributors, and consumer protection organizations who met in Brussels to work on their future plans to raise awareness of the widespread sale and use of falsified medicines across the world and the dangers associated with these fake products.
October 11, 2017
ASOP Global’s Executive Director, Libby Baney, presented the 2017 Global Patient Safety Champion Awards to the Honorable Michael C. Burgess, MD (R-TX-26), Chairman, House Energy and Commerce Subcommittee on Health; the Honorable Eugene Green (D-TX-29), Ranking Member, House Energy and Commerce Subcommittee on Health and the National Association of Boards of Pharmacy (NABP) at a Capitol Hill reception in Washington, DC.
Libby Baney and the Honorable Eugene Green
Libby Baney and Marty Allain, NABP
Libby Baney and the Honorable Michael C. Burgess, MD (R-TX-26)
June 29, 2017
The Alliance for Safe Online Pharmacies (ASOP Global) and the Alliance for Safe Online Pharmacy (ASOP EU) hosted the fifth Best Practice Sharing Workshop in Paris, France on June 29. ASOP Global’s Executive Director, Libby Baney, ASOP EU’s Mike Isles and Klaus Gritschneder, and NABP’s Policy and Communications Director, Melissa Madigan were joined by 20 EU member states and not-for-profit organizations where they discussed the need for more public awareness programs about falsified medicines like those previously conducted by ASOP Global in the U.S. and ASOP EU, as well as the “Common Logo”, which must appear on every online pharmacy selling medicine in Europe, and the latest progress relating to NABP’s .pharmacy top level domain (TLD) initiative.
Left to Right –
Hanne Hanken (Norway); Quentin Duteil (Fondation Chirac); Monika Macisowicz (Poland); Marion Barreau (IRACM); Klaus Gritschneder (ASOP EU); Mike Isles (ASOP EU); Lynda Scammell (UK); Sammy Kohli (Denmark); Sasa Polovic (Croatia); Melissa Madigan (NABP); Alain Denis (Belgium); Philippe de Buck (Belgium); Libby Baney (ASOP Global); Felicia Vaz (Fight the Fakes); Paul Brewer (UK); Aline Plancon (FMEDs Programme)
2017 European Association of Clinical Pharmacology and Therapeutics Congress (EACPT)
June 26, 2017
Prague, Czech Republic
Mike Isles, executive director of ASOP EU, and other international experts led the Global Health/Access to Safe Medicines Session during the 2017 European Association of Clinical Pharmacology and Therapeutics (EACPT) Congress, which was held in Prague from June 24-27. Watch the panel discussion featuring the experts listed below.
Pavle Zelic, Medicines and Medical Devices Agency, Serbia
Josez Glasa, Slovak Medical University, Slovakia
Mike Isles, ASOP EU and EAASM
Prof. Donald Singer, Clinical Pharmacologist, EACPT
and President, Fellowship of Postgraduate Medicine
June 5, 2017
Quebec City, Canada
May 20, 2017
ASOP Global’s Executive Director, Libby Baney, and NABP’s Policy and Communications Director, Melissa Madigan and Ronald F.Guse, an NABP .pharmacy Canadian consultant, member of the board of the Canadian Patient Safety Institute and former Manitoba Provincial Regulator were the speakers at the first Canadian Internet Drug Sales Roundtable, which was held during NABP’s 113th annual conference in Orlando, FL.
April 28, 2017
ASOP Global and The Pew Charitable Trusts held a briefing on Capitol Hill to discuss illegal online pharmacies; protections provided by the Drug Supply Chain Security Act; risks associated with legalizing importation of prescription medicines from Canada and other countries; and consequences for patients who are exposed to unsafe products.
March 28-31, 2017
ASOP Global’s Libby Baney and experts from the U.S. FDA, USP and University of Maryland were among the speakers at the APEC RHSC Regulatory Science Center of Excellence for Product Quality and Supply Chain Pilot Program held March 28-31, 2017.
March 22-24, 2017
Mike Isles, Executive Director of the EAASM and ASOP EU presented at the symposium entitled “Access to Unlicensed Medicines; Right Medicine, Right Patient, Right Time.”
March 11-16, 2017
ASOP Global’s Matt Rubin and ASOP EU’s Mike Isles presented ASOP Global’s inaugural Internet Pharmacy Safety E-Commerce Leadership Award to Rightside and Realtime Register during the Generic Names Supporting Organization (GNSO) Joint Meeting of the Registries and Registrars Stakeholder Groups at ICANN58 in Copenhagen.
March 1-2, 2017
New Delhi, India
ASOP Global’s Libby Baney and Jeff Gren were joined by 160 representatives from the Government of India (Gol), Partnership for Safe Medicines (PSM) India Initiative, International Alliance of Patients’ Organizations (IAPO), Indian Pharmacopeia Commission (IPC), U.S. Pharmacopeial Convention (USP) and other international organizations for this two-day event.