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Events

PRESS RELEASE: Member States obliged to inform the public about falsified medicines and the Common Logo – new report reveals the need for greater collaboration

In collaboration with the European Association of E-Pharmacies (EAEP) and the Alliance for Safe Online Pharmacy in the EU (ASOP EU), a survey was constructed to better understand Member State’s legal obligation to inform the public about falsified medicines and the Common Logo*.

ASOP EU and the EAEP firmly believe that given the rising scourge of falsified medicines (where criminals have stepped up their illegal activities especially during COVID and since), it is essential that the public is made more aware of websites that sell medicines illegally as well as understanding how they can access authentic medicines via the Internet.

The survey carried out with 12 Member States revealed the following key points:

All respondents regarded that it was a high or medium priority to publicise the meaning of the Common Logo and falsified medicines
Many MSs had now reverted to static website pages as part of the agency website and so there was little evidence of impactful contemporary active outreach campaigns
MSs were keen to collaborate and run campaigns collectively.

Based on the survey results, the following recommendations were made in the report (click here to read the report):

Recommendation 1: Design a collective outreach “generic” campaign by Member States
Recommendation 2: Set up a workshop with EAEP and ASOP EU with stakeholders to examine the success of such a campaign among customers/patients
Recommendation 3: Create a community of interested parties to enable further Member State collaboration on the important topic of falsified medicines and educational approaches.

*Falsified Medicines Directive: The Falsified Medicines Directive aims to prevent falsified medicines entering the legal supply chain and reaching patients. It introduces harmonised safety and strengthened control measures across Europe by applying new measures, such as the EU Common Logo for online pharmacies.

*EU Common Logo: The common logo for legally operating online pharmacies/retailers in EU countries was first introduced by Directive 2011/62/EU (Falsified Medicines Directive) as one of the measures to fight against falsified medicines. Article 85D of the Directive, legally obliges each Member State to provide information campaigns to inform the public about the meaning of a falsified medicine as well the EU Common Logo.

The logo consists of a national flag in the middle left side of the logo which corresponds to the EU country where the pharmacy or retailer is registered or authorised. Only national flags of EU countries or those of Norway, Iceland and Liechtenstein feature.

ABOUT EAEP
The European Association of E-Pharmacies (EAEP) represents the voice of e-pharmacies on the European continent. The EAEP promotes its interests mainly with political stakeholders, regional and business actors, with the ultimate aim to improve the health of Europe’s citizens and strengthen the European healthcare system.

Press Contacts
EAEP: martino.canonico@eaep.com

ABOUT ASOP EU
The Alliance for Safe Online Pharmacy in the EU (ASOP EU) is a not for profit Community Interest Company and represents a multi-sectorial coalition of organisations and individuals, dedicated to creating an environment that enables patients to buy their medicines online safely (where it is legal to do so).

Press Contacts
ASOP EU: mike.isles@asop.eu

Video and event summary of event of 12th February 2024 “The EU Pharmaceuticals – why should online access to prescription medicines be allowed?”

February 20, 2024

On 12 February 2024, the European Association of E-Pharmacies (EAEP) and the Alliance for Safe Online Pharmacy in the EU (ASOP EU) co-hosted an event in Brussels to discuss patients’ access to prescription medicines online in the European Union, particularly in light of the ongoing reform of the EU General Pharmaceutical Legislation, which presents an opportunity to enhance existing frameworks across the 27 EU Member States. The event aimed to facilitate a dynamic conversation on the benefits, challenges, and future trajectory of online access to prescription medicines. It targeted a diverse audience, including EU policymakers and major influencers in the EU health policy space with the goal of promoting the harmonisation of the EU’s approach to online pharmacies.

A key highlight of the event was the official launch of the recently published Copenhagen Economics report, “Unlocking the Benefits of Online Access to Prescription Medicines Across the EU”, commissioned by ASOP EU. Bruno Basalisco, Director of Copenhagen Economics, presented the findings of the report, which examines the benefits – or potential benefits – for patients of access to prescription medicines online, in Spain, France, Italy, Germany, and Sweden, unequivocally emphasising the urgent need for enhanced digital accessibility to, especially for individuals in rural areas and those managing chronic illnesses.

Click here to read the full event summary.

PRESS RELEASE: Unlock potential of online prescription medicines in Europe – new report calls for more widespread access

BRUSSELS, 7 FEBRUARY 2024 – Access to prescription medicines online is a crucial tool in enhancing healthcare, but it remains unequal across Europe, a report has found. The report, released by Copenhagen Economics and commissioned by the Alliance for Safe Online Pharmacy in the EU (ASOP EU), says the chronically ill and those in remote areas would benefit the most if more Member States allowed online access through registered pharmacies.

Key findings:

Convenience and flexibility: Patients value the convenience and enhanced flexibility offered by online access and home delivery of prescription medicines through registered pharmacies.
Better health outcomes: Chronically ill patients cite medicine unavailability, forgetting refills, and time constraints as major contributors to non-adherence.

In light of the report findings, a set of policy recommendations is put forward:

Improve the availability of medicines online by encouraging Member States to take the necessary steps towards allowing online access to prescription medicines by updating the General Pharmaceutical law under revision and reassess national restrictions.
Strengthen the accessibility of medicines online by improving the awareness of existing secure supply chain safeguards whether operating offline or online.
Facilitate digital expansion of pharmacy operations by removing existing regulatory restrictions.

Commenting on the report, Michael Isles, Executive Director, Alliance for Safe Online Pharmacy in the EU said: “This report will be instrumental in highlighting how all EU citizens should have the same rights to access their prescription medicines as in other Member States. Digital pharmacy services are rapidly developing and are a crucial tool to enhance healthcare across the EU and beyond. In addition, the sooner the public is knowledgeable about where to obtain their medicines safely online the sooner the battle against falsified medicines will be won.”.

“Our analysis shows the potential for increased adherence to prescribed medication if online access is permitted and this would help to ensure better health outcomes for European patients.” added Dr Bruno Basalisco, Director, Copenhagen Economics. “Patients all over Europe are today more proficient digital users and value the convenience of online access. We believe these data reflect widespread unserved consumer demand for online services from registered pharmacies, which will be instrumental to help enhance the existing EU and national frameworks that regulate the sale of medicinal products at a distance.”.

At these unprecedented times for EU pharmaceutical regulation, policymakers in Europe could consider the opportunities related to enhancing patient access to prescription medicines in a digitised world.

Background:

Over the past decade, online purchasing from authorised pharmacies has become an accepted practice across many EU Member States. Despite the legal framework provided by the EU pharmaceutical legislation, online access to prescription medicines remains restricted in most Member States: eight EU Member States have been operating online services safely and efficiently for many years now. The regulations in respect of dispensing medicines, apply equally to offline physical pharmacies as to online pharmacies. The medicines dispensed in all Member States have the safety features prescribed by the Falsified Medicines Directive¹, incorporated in the General Pharmaceutical Law (unique identifier and tamper evident seal). However, patients in the remaining Member Sates face restrictions, as national laws dictate that prescription medicines can only be dispensed at physical pharmacies.

The report focuses on France, Germany, Italy, Spain and Sweden, providing valuable insights into patients’ perspectives and offering clear policy recommendations.

For media enquiries, please contact:
Acumen Public Affairs
media@acumenpa.com

1. DIRECTIVE 2011/62/EU of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.

FIP Digital Event – Falsified Medicine and Misinformation on the Internet: Public Risk and Solutions

On July 12, 2022 the Alliance for Safe Online Pharmacies (ASOP Global), ASOP EU, and the National Association of Boards of Pharmacy (NABP) teamed up to present the FIP worldwide educational event Falsified Medicine and Misinformation on the Internet: Public Risk and Solutions.

Consumers throughout the world are increasingly looking to the internet to purchase their drugs. The worldwide pandemic has caused many consumers who had not done so previously to look to the internet for healthcare, healthcare information, and medicinal products. However, at any given time, 95% of the roughly 35,000 online drug sellers worldwide operate illegally, in violation of laws and placing consumers at risk.

Regulators throughout the world are monitoring the level of nefarious drug sellers and “medical clinics” on the internet. Regulatory solutions to combat and remove the presence of these harmful vendors and sites have not been widely implemented. Raising public awareness among consumers, healthcare providers, lawmakers, and social media platforms is an important step toward addressing the dangers of illegal online drug sellers and protecting patients.

Ronald Guse, chair of FIP Regulators Forum, moderated the discussion with panelists Senior Advisor to ASOP Global and Partner, Faegre Drinker LLP Libby Baney, Director of ASOP EU Mike Isles, and NABP Digital Health Senior Manager Justin Macy. Together they explored the impact of illegal online drug sellers and bogus medical clinics on the internet on the unsuspecting public and identified programs and initiatives currently in place to combat misinformation and enhance internet consumer safety.

You can watch the event and learn more here.

HIV Prevention and Treatment – The Threats of Illegal Online Drug Sellers to Public Health and Patient Safety Webinar

On Monday, June 28, 2021 ASOP Global Foundation hosted a free healthcare provider webinar: HIV Prevention and Treatment – The Threats of Illegal Online Drug Sellers to Public Health and Patient Safety. The discussion examined strategies healthcare professionals can use to educate people living with HIV and people at risk for HIV about the dangers of buying antiretroviral therapies (ART) and pre-exposure prophylaxis (PrEP) medications through illegal online sources as well as ways to access safe, legitimate medicines.

Expert panelists weighed in on recent trends on consumer use of the internet for healthcare products, and how this will shape the patient provider relationship in the future.

Expert panelists included:

Libby Baney, JD, ASOP Global Foundation Senior Advisor
John Hertig, PharmD, MS, CPPS, FASHP, ASOP Global Board President
Arash Debastani, PharmD, MHA, FASHP, FABC, Dean, Long Island University School of Pharmacy
Rebecca Kavanagh, PharmD, BCACP, AAHIVP, Director, Co-Curriculum and Developmental Portfolios, Touro College of Pharmacy
Michael Liu, PharmD, BCCCP, BCNSP, BCPS, Assistant Dean of Clinical and Professional Affairs, Touro College of Pharmacy

Click here to view a video recording of the webinar and here for the presentation slides.

To access ASOP Global Foundation’s toolkit to educate patients, providers, and community organizations about the dangers of purchasing medications online, click here.

Coming Soon: Dangers of Fake Medicines Online

December 8, 2020

Join us for a webinar to learn about fake medicines online from experts in the field! Register to attend here.

Information about Speakers

Youth IGF Movement Form Alliance With French Healthcare Companies, ASOP EU To Launch A Global Education Programme To Combat COVID-19 Scams And Fake Medicines

June 10, 2020

The Youth IGF Movement, created by Yuliya Morenets, has teamed up with the Alliance for Safe Online Pharmacy (ASOP EU) supported by three French global healthcare companies Ipsen, Sanofi and Servier to educate the youth about buying fake medicines online, in particular COVID-19 scams. Announced in a press release, the campaign is called “We rely on you. We rely on youth”. All of the different country event timings will be posted on Facebook here. Please do join the events on Facebook, Instagram, Twitter and TikTok via @globalyouthigf and @ASOP_Europe, and follow the conversation on #RelyOnYouth

Learn more about fake medicines online and how you can stay safe, please see explanatory leaflets below:

For further information, please see below:

ASOP Canada and The Globe and Mail Webinar “Tackling Health Fraud”

May 20, 2020

In partnership with The Globe and Mail, ASOP Canada hosted a webinar to educate viewers about health fraud on the internet. Health care experts and law enforcement officials in the U.S. and Canada joined to discuss the rise in fraudulent medical products related to COVID-19 sold on the internet. This ranges from substandard PPE to so called “cures” for the disease. The panel discussed ways consumers can stay safe online and ideas for how law enforcement and domain registration companies can work together.

Speakers included Steve Francis, director of the National Intellectual Property Rights Coordination Center, Sandra Hanna, CEO of the Neighbourhood Pharmacy Association of Canada, April Miller, Assistant Attache with Homeland Security Investigations with the U.S. Consulate General in Toronto and Jeffrey Thomas, senior RCMP intelligence analyst with the Canadian Anti-Fraud Centre.

OECD TF-CIT Worldwide webinar “Illicit Trade at the time of the COVID-19 Crisis”

April 23, 2020

The goal of the April 23rd webinar Illicit Trade at the time of the COVID-19 Crisis, hosted by the Organisation for Economic Co-operation and Development (OECD), was to determine the implication of the current COVID-19 pandemic on global illicit trade.

The webinar raised debate on the following topics:

What changes in illicit trade flows do we see today?
What changes, impacts and evolutions can we expect in the nearest future? How will governments adjust their governance actions?
What are the challenges for effective international co-operation to react to these changes?

ASOP EU gave a practical solutions-oriented overview that focused on a comprehensive policy solution to fraud, misinformation and consumer harms online: freeing up the WHOIS database and ensuring a robust Domain Name Accountability system. This attracted interest from a number of participants and ASOP EU is now following up to effect concrete policy discussion and change across the EU institutions.

ASOP Global Participates in WHOIS Briefing on Capitol Hill

Washington, D.C.
October 17, 2019

The Alliance for Safe Online Pharmacies (ASOP Global) participated in the Coalition for a Secure and Transparent Internet (CSTI) Capitol Hill briefing: What is WHOIS: Understanding One of Our Most Critical Cyber Assets.

CSTI convened law enforcement officials from the Department of Justice and Drug Enforcement Administration, along with representatives from the National Association of Boards of Pharmacy, Motion Picture Association of America and Kroll to discuss with policymakers how restricted access to WHOIS data impacts their investigations and ultimately public safety.

Online, at this moment, there are tens of thousands of websites offering illegal pharmaceutical drugs to Americans sourced from clandestine supply chains. Most sites selling drugs illegally online do not post any address, and nearly half have their domain names registered anonymously.[1] These illegal and dangerous – sometimes deadly, drug sellers operate with reckless regard for patient health and public safety. This is especially true now, during the opioid epidemic.

As the U.S. Food and Drug Administration (FDA) reports[2], public information about the owner of a domain name, known as “whois” data, is now often impossible to access with the implementation of the European General Data Protection Regulation (GDPR). Unlike FDA,

manufacturers of illicit prescription drugs do not need to consider legal treaties, jurisdictions, or conflicting legal frameworks.[3] This critical briefing affirmed the vital role internet transparency plays in protecting patient safety and stressed the urgent need for timely solutions.

Photo Captions:

Photo One: (L-R) Jae Chung, Assistant Special Agent in Charge, Pharmaceutical, Chemical & Internet Investigations Section, Special Operations Division, U.S. Drug Enforcement Administration and Jason Gull, Senior Counsel, Computer Crime and Intellectual Property Section (CCIPS), U.S. Department of Justice

Photo Two: (L-R) Neil Fried Senior Vice President of Federal Advocacy and Regulatory Affairs, Motion Picture Association of America, GG Levine, Digital Health Manager, National Association of Boards of Pharmacy and Alan Brill, Senior Managing Director, Kroll

[1] National Association of Boards of Pharmacy, August 2017 Internet Drug Outlet Report: https://nabp.pharmacy/wp-content/uploads/2016/08/Internet-Drug-Outlet-Report-August-2017.pdf

[2] U.S. FDA Testimony Before the Caucus On International Narcotics Control, U.S. Senate. October 2, 2018 https://www.drugcaucus.senate.gov/sites/default/files/FDA%20Testimony%20on%20Fentanyl%20final.pdf

[3] Ibid.

2019 ASOP Global and ASOP Global Foundation All-Hands Strategy Session

Washington, DC
September 11-12, 2019

ASOP Global and ASOP Global Foundation convened their annual All-Hands Strategy Session in Washington, DC. Members and observers gathered to discuss initiatives for keeping patients safe when buying medicine online, and furthered the conversation surrounding hot topics including opioids, drug importation and the role of internet intermediaries. The two-day session was jam-packed with compelling presentations and speakers, including guests from the FDA and WHO.

Day one of the meeting provided stakeholders with a comprehensive update on ASOP’s 2019 accomplishments while cultivating a robust dialogue around the organization’s strategic plan for the year to come.

Day two included a visit to Capitol Hill, where ASOP Global presented Representative David. B. McKinley with its 2019 Patient Safety Champion Award. Rep. McKinley, who has been instrumental in tackling the opioid epidemic, was recognized for his unwavering leadership and dedication to patient safety.

Photo captions:

Annual All-Hands Meeting for ASOP Members and Observers;

Katherine Bond, ASOP Global Board President;

ASOP Global Team and Patient Safety Champion Rep. David. B. McKinley

2019 ASOP Global Trip to Brazil

Sao Paulo and Brasilia, Brazil
August 2019

After a successful initial trip to Latin America in September 2018, ASOP Global coordinated a second delegation trip to Sao Paulo and Brasilia on August 12-16, 2019. Following the collaborative meeting series, the ASOP Global team identified several opportunities for future trips and work in Brazil to expand cooperation with the local government and private sector partners. This ongoing collaboration will focus on promoting private sector self-regulatory actions to combat online internet drug sales, implementing a series of training programs and workshops, and expanding the usage of .pharmacy in Brazil.

The ASOP Global Brazil delegation included Jeffrey Gren (ASOP Global Board Member); Luciana Takara (USP Brazil Office); and Danielle Talita Cantóia Campos (Lilly Brazil Office), and was supported by John Hertig (representing FIP) and Ron Guse (NABP) via remote connection.

ASOP Global Facilitates Panel at USP-APEC Center of Excellence Dialogue and Training

Santiago, Chile
June 12, 2019

ASOP Global participated in the three-day USP-APEC Minimizing Quality Risks in the Upstream and Downstream Supply Chain Conference at the Center of Excellence in Santiago, Chile from June 11-13. Libby Baney, Senior Advisor to ASOP Global, delivered a keynote on Global Internet Pharmacy Best Practices and facilitated a panel on Opportunities for Collaboration and Implementation of Best Practices. ASOP EU Executive Director Mike Isles provided a European perspective at the international session and ASOP Director Matt Rubin led a plenary session discussion. To view the full agenda, click here.

ASOP Global to Participate in USPTO Forum on Brand Protection and Anti-Counterfeiting Strategies

Alexandria, VA
June 6, 2019

On June 6 ASOP Global will participate in the upcoming Forum on Brand Protection and Anti-Counterfeiting Strategies at the United States Patent and Trademark Office (USPTO). Policymakers, practitioners, and anti-counterfeiting experts will convene and examine policies and strategies on topics including fighting counterfeits in a global market, utilizing new technologies, consumer protection and more. Libby Baney, Senior Advisor to ASOP Global, will be a panelist in the Public Messaging as a Strategy in the Consumer Protection and Counterfeits session.

Coming Soon: ASOP EU Will Be a Supporting Partner for International Conference on Illicit Trade and Falsified Medicines

Zurich, Switzerland
June 18 – 20, 2019

This June, ASOP EU will participate in an important international conference where industry, healthcare and patient safety experts will exchange information on the rising tide of falsified medicines and how leading edge supply chain security solutions can combat this. Presenter Mike Isles, Executive Director of ASOP EU, will offer an examination of the growing digitalization of product supply, and offer insights on the threats posed by online pharmacies and how education can help protect patients.

Law Enforcement in Portland Use ASOP Resources to Raise Awareness About Patient Safety

Portland, OR
April 27, 2019

The Portland Police Bureau (PPB), the Office of Community & Civic Life Crime Prevention section and the Better Business Bureau hosted their annual Shred/Rx Turn-In Day on April 27.

The community event attracted more than 700 participants who brought their unused or unwanted drugs, along with unwanted documents, to be safely disposed.

PPB White Collar Crime Division Detective Cheryl Waddell, who helped coordinate the annual event, shared copies of ASOP Global’s Ways to Stay Safe and Save brochures.

“We’re here to help the community [by] making sure unused or unwanted drugs are safely disposed, and don’t find their way into the hands of youngsters who might want to experiment – or ‘dumpster divers’ looking for narcotics,” said Det. Waddell.

To read more, click here.

ASOP Global Engages International Health Regulators at APEC

Santiago, Chile
February 28 – March 3, 2019

On March 2^nd, representatives from ASOP Global had the opportunity to brief members of the Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum around ongoing efforts to encourage international collaboration to combat the illegal advertisement and sale of prescription drugs online.

As the host economy, Chile and representatives from the Institute of Public Health – under the Ministry of Health – expressed significant interest in this issue, placing it as a priority topic for the meeting and future engagements.

ASOP Global shared with the 15 economies present a general overview of the threats posed by illegal online drug sellers and existing efforts to promote international collaboration, building upon a comprehensive introduction by representatives from the Chilean health authorities.

Additional efforts are underway to further advance dialogue and collaboration between ASOP Global and the participating economies to develop best practices and encourage coordination on efforts to improve patient safety and public health online.

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EU Parliament – Falsified Medicines Directive Meeting

Brussels, Belgium
February 19, 2019

There has been much talk about the difficulties of implementing a robust process-driven verification system of prescription packs within the hospital settings across Europe. Depending on which hospital pharmacist you talk to, you will still get a rainbow of opinions. This in despite of the legal implication, that as of 9th February 2019 all pharmacists should be ready to fulfill the final stage of the Falsified Medicines Directive’s (FMD) safety features that will help ensure the patient is protected from falsified medicines. Opinions range from “We have implemented the Directive and can see great halo benefits” to those that feel “It adds no value, only extra work and cost”.

The EU Parliament meeting on 19th February titled “Improving patient safety with the FMD in the hospital pharmacy, status of implementation – are we ready?” was initiated by the European Alliance for Access to Safe Medicines (EAASM) in collaboration with MEP José Inácio Faria to support the final elements of the FMD. The programme was designed to dispel some of these myths and establish a firmer base for the sharing of best practices by bringing together a team of experts to offer their advice and expertise.

From the technical perspective, the head of the IT solution whose repository captures all of the bar-coding data, Andreas Walter (General Manager – European Medicines Verification Organisation) stated the system had been built in all 28 Member States and that there is the need for a period of stabilisation and inspection measures. This is the largest verification system initiative in the world which is further complicated by the commitment for each Member State to construct a compatible subsidiary nationally based IT architecture.

The example of a very successful implementation was presented by Maija Gohlke kokkonen, General Manager of the Finnish Medicines Verification Organisation. Despite 83% of transactions which have been successful, there are still challenges faced by hospital pharmacies and four in-country views by experts as well, as the European Association of Hospital Pharmacists (EAHP) presented their practical solutions to the implementation of the FMD.

Challenges such as procurement of new IT systems, volume of packs, complexity of distribution pathways within the hospital, slow decommissioning, staffing resource issues, planning procedures for in-bound stock, identifying who can perform the decommissioning and the need for a standing buffer were all cited.

Critical success factors were identified as:

Support from national bodies to ensure alignment and financial support where possible across the national health system;
Communication between stakeholders (from hospital to hospital and allied services; ambulance services etc.) to standardise the processes to ensure that the technology platforms are compatible and fully integrated into existing workflow;
The relationship with third-party automation providers and their understanding and cooperation to work out the final optimal approach
Definition and handling of false alerts
A clear and understandable language within the system read outs
The use of technology to overcome the manual burden placed on hospitals was required with robotics as a way to facilitate the implementation process.

The final presentation by Agnès Mathieu Mendes of the Directorate-General for Health and Food Safety of the European Commission forcefully reminded the audience that falsified medicines are a serious public health concern. They harm patients and affect every region in the world. Between 2013 and 2017, the Commission received 400 notifications of falsification in the EU and in 2017 around 7 million euros worth of counterfeit medicines were seized at the EU border.

10 days after the implementation date of the FMD, the European Hub functions properly and no major issues have been identified so far. All databases are connected and connection to end-users is in progress. The Commission is an observer who tries to facilitate the discussion between stakeholders as the level of awareness is still not sufficient and so there is a need for more outreach to actors. DG SANTE had set up a sub group of Member States to investigate possibilities of having a system of data files with suppliers instead of aggregation where they can ensure decommission under certain safety checks.

While it is clear there is a need for a period of stabilization, European policymakers will continue to help and dialogue with EU Member States; hence it will be critical to work together at a local, national and European level to overcome existing challenges and protect patient safety, ensuring a controlled application of the NMVS as well as an uninterrupted medicines supply.

Read the full report.

More information on the event are available here.

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ASOP EU Presents at Upcoming G2 Risk Summit Series

Riga, Latvia and London, England
January 31, 2019 and February 6, 2019

On both occasions, Director Mike Isles and the Secretariat run by Laura Cigolot will be addressing the rising tide of falsified medicines in Europe and related legislation, with a major focus on Article 85d of the Falsified Medicines Directive and the EU Common Logo. They will be presenting ASOP EU activities to enhance Internet patient safety and raise awareness about falsified medicines, including Parliamentary meetings, the educational campaign in five EU countries and the latest report which highlights what gaps still exist in consumer/patient education, and calls upon relevant authorities to continue to build on the many initiatives that raise public awareness which in turn will help to combat this growing threat to public health. They will share the topic with other like-minded organisations such as NABP, whose top-level domain initiative of .pharmacy is another important step to enable patients to go to a secure place to buy medicines. In addition, ASOP Global Board Member John Hertig, PharmD, MS, CPPS Associate Professor at Butler University Indianapolis, Indiana, USA will add his expert knowledge to this important topic.

ASOP EU addresses The British Medical Journal and Royal College of Physicians Annual Global Conference

London, England
December 3, 2018

Mike Isles, Executive Director of ASOP EU and the EAASM, addressed doctors at the Global Health Horizons – “Learning from the past, looking in to the future” symposium held at the Royal College of Physicians, in London. Mike expressed his deep concern that the public and therefore patients were not being made aware of the rising tide of falsified medicines – the title of his talk.

He emphasised the need for all stakeholder engagement and stressed the role that doctors could play to help educate the public. Mike stated that most patients will have explored their health issues by searching the Internet. Doctors, community or hospital, have a clear duty of care to ascertain, as much as they can, if their patients have bought medicines from the Internet. With 35,000 illicit websites aimed at the European citizen and an estimated 130 million people in Europe buying medicines online, this underlines the importance of doctors taking a pro-active stance.

Mike also took the opportunity to reveal ground breaking evidence collected from the ASOP EU/EAASM educational website. With over 2300 survey responses from would-be buyers of medicines online, the respondents revealed an overwhelming desire to change their behaviour and find a safe, genuine place to buy their medicines, once they understood that 96% of websites visible from the Internet in Europe are illegal.

Mike Isles, Executive Director ASOP EU/EAASM

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ASOP Global Foundation 2018 Research Symposium

Washington, DC
November 14, 2018

The growing threat of illegal online pharmacies coupled with the ongoing opioid crisis makes robust research and education more critical than ever for health professionals, law enforcement, and policymakers as they work to help patients stay safe online.

On November 14 at the National Press Club, the Alliance for Safe Online Pharmacies Foundation convened its inaugural Research Symposium. The event featured leading academic research presentations and thoughtful dialogue on timely topics, including patient safety and medication quality online, internet intermediary responsibility, law enforcement best practices, and consumer behavior online.

The Food and Drug Administration’s Office of Compliance Director Donald Ashley and Office of Pharmaceutical Quality Director Michael Kopcha delivered the Symposium’s keynote addresses about the role the FDA plays in combatting illegal online pharmacies. Caitlin Owens, healthcare reporter at Axios, moderated the Symposium’s closing roundtable discussion about emerging research questions and strategies for leveraging research to guide policy, educate stakeholders, and improve patient care.

ASOP Global Foundation and its members will use learnings from the Symposium to develop a new research agenda to inform future efforts aimed at protecting patients online.

To view speaker presentations from the Symposium, please click here. The full Symposium agenda, speaker bios and discussion takeaways can be found here.

Photo captions:

Sally Greenberg, National Consumers League;

L-R: Mike Isles, Louise Shelley, Tim Mackey, Marty Allain, John Hertig, Beena Patel, Libby Baney, and Matthew Rubin;

L-R: Caitlin Owens, John Hertig, Tim Mackey, Louise Shelley, and Anne Snowdon;

Michael Kopcha, Food and Drug Administration

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ASOP EU and the Youth Internet Governance Forum Movement Collaborates to Raise Awareness About Fake Medicines

Paris, France
November 12, 2018

On 12^th November 2018, the Alliance for Safe Online Pharmacy in the EU (ASOP EU) held the first meeting with the Youth Internet Governance Forum Movement (Youth IGFM) at the worldwide Internet Governance Forum (IGF) Paris 2018 co-hosted with UNESCO. President of France Emmanuel Macron sent a clear message for a strengthened IGF which should provide concrete policy outputs, as it serves as a multi-stakeholder forum open to all to share ideas and advance discussions on Internet governance issues.

ASOP EU and TaC-Together Against Cybercrime International, coordinator of the Youth IGF two non-profit organisations committed to work together to support the Youth IGF Movement (IGFM). The Movement was conceived during the First French Youth and Teenagers Internet governance Forum in France in 2011 at the Council of Europe to inspire young people across the world to discuss and take a lead on Internet-governance related issues.

Youth IGFM Ambassadors from six different countries, Indonesia, Haiti, Lebanon, Portugal, UK and Ukraine, met to learn about the rising tide of fake online medicines. 35,000 websites advertise and sell prescription and OTC medicines on any given day around the world and with 96% operating illegally the seriousness of the situation was underlined. Furthermore, medicines bought online may contain too much, too little or no active ingredients at all. Some even have dangerous or deadly substances like paint thinner, rat poison or fentanyl endangering life and health.

They also learnt that consumers risk economic, personal data or cybercrime when purchasing drugs from an illegal online pharmacy.

The young ambassadors collectively brainstormed and shared thoughts on how best to educate and raise awareness amongst young citizens in their respective countries. The possibility of a unified worldwide annual awareness day to speak out against fake medicines which is killing one million people per year, was one of the concrete actionable ideas to come out of the meeting.

To learn more about the Youth IGF, please go to the website www.youthigf.com

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ASOP Global Delegation India Trip

Delhi, India
October 30 – November 1, 2018

The Alliance for Safe Online Pharmacies (ASOP Global) completed a delegation trip to Delhi, India (October 30 – November 1, 2018). During this trip the delegation had meetings with the following organizations – WHO SEARO, the Office of the Drug Controller General of India, the Pharmacy Council of India, PHD Chamber of Commerce and Industry, AmCham India, NITI Aayog, Patient Safety and Access Initiative of India, the Quality Council of India and Digital Health Platform. The ASOP Global India delegation included Jeffrey Gren (ASOP Global Board Member), Bejon Misra (ASOP Global India Chapter), Alastair Jeffrey (Great Britain MHRA), Chaitanya Kumar Koduri (USP India Office), Aaron Graham (Boehringer Ingelheim), Ron Guse (Consultant National Association of Boards of Pharmacy) and Jim Fries (Rx-360).

ASOP Global received strong support during these meetings and discussed possible assistance to the Government of India in the implementation of draft India regulations on the registration of India on-line pharmacies. ASOP Global has also discussed the possibility of providing the Government of India assistance, once the new regulations are in effect. ASOP Global is a nonprofit organization that works to protect patients through public awareness and promotes safe ways for consumers and patients to purchase on-line medicines. More information can be found on ASOP Global’s website – www.BuySafeRx.Pharmacy, or by contacting Bejon Misra, the Strategic Advisor for the ASOP Global India Chapter at BejonMisra@gmail.com. Below are several pictures from the India meetings.

Photo captions (L-R): ASOP Global meeting with WHO SEARO; Meeting with the Office of the Drug Controller General of India, ASOP Global Delegation members and India Stakeholders; ASOP Global meeting with the Quality Council of India; ASOP Global meeting with the AmCham India, US Commercial Service and USPTO staff based in Delhi

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ASOP Global’s Annual Internet Pharmacy Safety Award Presented to .DK Hostmaster

Barcelona, Spain
October 22, 2018

The Alliance for Safe Online Pharmacies (ASOP Global) presented its annual Internet Pharmacy Safety E-Commerce Leadership Award to .DK Hostmaster at the 2018 ICANN63 on October 22, 2018.

The domain name administrator for Denmark, DK Hostmaster, was selected for the award based on their commitment to ensuring citizen safety by maintaining transparent WHOIS data, proactively enforcing identity accuracy policies to increase consumer trust and safety online.

Women in Government Healthcare Summit

Washington, DC
October 5, 2018

ASOP Global advisor Libby Baney participated in an Ensuring Safe Medicines panel discussion at the 9th Annual Women in Government Healthcare Summit in Washington, DC on October 5, 2018. The session was moderated by Karin Bolte, Senior Director of Health Policy for the National Consumers League. The discussion focused on illegal online pharmacies, counterfeit medicines and patient safety. Other panelists included Elizabeth Jungman, Director of Public Health Programs for The Pew Charitable Trusts and Michael Cummins, Special Agent at the FDA Office of Criminal Investigations.

ASOP Global Trip to Brazil

Sao Paulo and Brasília, Brazil
September 2018

The Alliance for Safe Online Pharmacies (ASOP Global) began a Latin America initiative during 2018. We completed a successful series of meetings in Mexico City September 4 – 8, and during the week of September 10 the ASOP Global delegation had significant meetings in Sao Paulo and Brasília, Brazil. The ASOP Global Brazil delegation included Jeffrey Gren (ASOP Global Board Member), J. J. Saul (ASOP Global Consultant) and Luciana Shimizu Takara (USP Brazil Office).

Brasilia meetings included Brazil ANVISA, U.S. Embassy staff (Commercial Service and Department of Health and Human Services) and FCC (Brazilian Federal Council of Pharmacy). São Paulo meetings included the US Commercial Service, AmCham Brazil, Mercado Libre, FNCP (National Forum Against Piracy), Sindusfarma, Interfarma and the USP Brazil Office. Jeff, J. J. and Luciana gained great insight into the current status of drug safety and online sales of medicines in Brazil. This information will be used as ASOP Global continues to work with Brazil partners and organizes the 2019 ASOP Global delegation trip to Brazil. Below are several pictures from the Brazil meetings.

ASOP Global is a nonprofit organization that works to protect patients though public awareness, promoting safe ways for consumers to buy medicines online and cooperative activities with regulators, customs and law enforcement officials to protect patients by taking down unsafe websites selling substandard or falsified medicines.

ASOP Global will back in Brazil during 2019 with a delegation for further collaboration with Brazil partners. There are significant opportunities in Brazil for following-up activities in partnership with the Brazil organizations we met with. More information can be found on ASOP Global’s website – www.BuySafeRx.Pharmacy.

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ASOP Global Trip to Mexico City

Mexico City, Mexico
September 4 – 8, 2018

The Alliance for Safe Online Pharmacies (ASOP Global) began a Latin America initiative during 2018. Jeff Gren and J. J. Saul completed a September 4 – 8 trip to Mexico City to meet with partner organizations in advance of a 2019 ASOP Global delegation trip to Mexico. Jeffrey Gren is an ASOP Global Board Member and J. J. Saul serves as a consultant to ASOP Global.

During the trip to Mexico, Jeff and J. J. met with Mexico COFEPRIS, Mexico pharmaceutical industry associations, the U.S. Food and Drug Administration – Mexico City Office, U.S. Commercial Service staff and the Mexico City Mercado Libre office. ASOP Global made additional Mexico contacts by attending the September 6 Mexico Health Summit.

ASOP Global received strong support during these meetings and below are several pictures. Industry associations ASOP Global met with includes: AMIIF, CANIFARMA, ANAFAM and the México National Association of Pharmacies.

Jeff and J. J. gained great insight into the current status of drug safety in Mexico and online sales of medicines in Mexico. This information will be used as ASOP Global continues to work with Mexico partners and plans the 2019 ASOP Global delegation trip to Mexico. The ASOP Global delegation trip to Mexico will be timed to take place after new Mexico government officials are in place with the new President of Mexico.

During the 2019 ASOP Global delegation visit to Mexico an educational seminar program is anticipated, as well as meetings with COFEPRIS and other Mexico government units, Mexico pharmaceutical and pharmacy industry associations and U.S. Government representatives. ASOP Global’s goals for Mexico include patient safety, public awareness and cooperation with partners to combat substandard and falsified medicines.

ASOP Global is a nonprofit organization that works to protect patients though public awareness, promoting safe ways for consumers to buy medicines on line, and work with regulators and law enforcement to protect patients by taking down unsafe websites selling substandard or falsified medicines. In addition to the Latin America initiative, ASOP Global also has activities in the United States, Europe, Canada, China, India and Asia Pacific Economic Cooperation (APEC).

ASOP Global will come back to Mexico during 2019 with a delegation trip for further collaboration with Mexico partners. More information can be found about ASOP Global on our website –www.BuySafeRx.Pharmacy.

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2018 AHC Global Supply Chain Integrity Training

Seoul, Korea
August 28 – 30

ASOP Global’s Libby Baney and Katie Neckers from the U.S. Food and Drug Administration hosted a session on Internet Sales at the 2018 APEC Harmonization Center’s Global Supply Chain Integrity Training in Seoul, Korea.

ASOP Global and the U.S. Food and Drug Administration at the 2018 APEC Harmonization Center’s Global Supply Chain event

ASOP Global Illegal Online Drug Sales Research Symposium

Washington, D.C., USA
November 14, 2018 – Save the Date

With the growing threat of illegal online pharmacies, coupled with the current opioid crisis, robust research and education is necessary to assist health professionals, law enforcement, and policy-makers as they help patients stay safe online.

Registration

ASOP Global Annual All-Hands Strategy Session and Hill Day

Washington, D.C., USA
November 15, 2018 – Save the Date

ASOP Canada Advocacy Day

Ottawa, Canada
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.

2018 APEC Harmonizing Center Global Supply Chain Integrity Training

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.

European Parliament Event – Raising Public Awareness About Patient Safety on the Internet

Brussels, Belgium
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.

Programme

Speakers List

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International Pharmacy Regulator Roundtable

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.

The meeting

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.

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ASOP EU and Together against Cybercrime International create the Youth IGF movement to educate young people about fake medicines

Brussels, Belgium
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.

ABOUT 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

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ASOP EU “All Hands” Meeting: Ambitious 2018 Objectives and Patient Safety Highlights

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:

SupportEU Commission DG Digital Single Market on strengthening measures against illegal content.
Explore putting in place a specific public relations campaign at Member State level to gain governmental support to carry out Article 85d (see page 26 of MS report). Opinion is being canvassed as part of the feedback.
Contribute to the Committee of Parties of the MEDICRIME Convention, if invited.
Continue to develop close liaison with Member States’ implementers of the Common Logo and hold further sharing best practice meetings. Publish a follow up report by Q4 2018.
Continue to develop the five country (France, Germany, Italy, Spain and UK) Google AdWord campaign.
Engage stakeholders to enable Principles of Participation, which is a voluntary code of practice for Internet intermediaries namely: Advertising Service Providers, Registries/Registrars, Shipping Companies, Payment System Operators.
Become active in ICANN policy discussions on several issues; EU General Data Protection Regulation (GDPR), WHOIS transparency, new generic Top-Level Domains
Continue the publication of the ASOP EU and EAASM newsletters.

ASOP EU “All Hands” Meeting

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China Delegation Trip Report to Promote Patient Safety and Access to Safe Online Pharmacies in China

Beijing, China
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:

Martin Blair, Asia Director, Pharmaceutical Security Institute;
Connie Feng (US Pharamcopeial Convention, Associate Director, China Office);
Jeffrey Gren (ASOP Global Board Member);
Alastair Jeffrey, Head of Enforcement, Medicines & Healthcare products Regulatory Agency (MHRA) United Kingdom; and
Sumin Zhang, Representing ASOP Global Board and Associate Government Affairs Director, Lilly).

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.

Alibaba Health;
China FDA, Department of Drug and Cosmetic Supervision;
China Pharmaceutical Innovation and Research Development Association (PhIRDA);
Chinese Pharmaceutical Association for Plant Engineering (CPAPE);
European Chamber of Commerce in China;
Partnership for Safe Medicines (PSM) Foundation;
QBPC (Quality Brand Protection Committee) Pharmaceutical and Medical Device IWG;
Research and Development Pharmaceutical Association of China (RDPAC);
United States Embassy;
US Food & Drug Administration China Office; and
US-China Healthcare Cooperation Program.

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.

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European Medical Association officially joins ASOP EU and EAASM

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.

Mike Isles and Vincenzo Costigliola

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ASOP Global Delegation to China

Beijing, 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.

ASOP Global Delegation

Global Patient Safety Champions Reception European Antibiotic Awareness Day: “Keeping Antibiotics Working”

Brussels, Belgium

November 18, 2017

ASOP attended the 10^th 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).

Dr. Vytenis Andriukaitis and Mike Isles

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:

A Google educational AdWord grant to raise public awareness in 5 major countries in the EU. With over 30,000 first page impressions per day and a higher than average click through rate there is growing evidence of the campaigns effectiveness. A survey attached to the website has received over 1100 responses which reveal behaviors ARE being changed.
Encouraging Member States and the Commission to share best practice on the implementation of the Common Logo and which obliges all Member States to allow “sales of medicines at a distance” – ergo over the Internet – and so a seller of a medicine must register with their local regulatory authority. The Directive also states that it is a legal obligation for both the Member States and the Commission to publicize the meaning of a Common Logo and a falsified medicine.
ASOP Global also has several public awareness-raising initiatives as well as being highly active in policy discussions with United States Congressional staff and the White House on Canadian online pharmacies and importation. They conducted the largest consumer survey to date in May 2017 (with accompanying report) to understand consumer perception and behavior around online pharmacies. ASOP Global also actively engages with US Government offices on issues relating to buying medicines via the Internet. In addition, ASOP Global has a full program to support Internet medicines governance issues around the world, including the Asia-Pacific region providing a supply chain tool and various specific activities in India and China.

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

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Fight the Fakes International Meeting

Brussels, Belgium
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.

2017 Global Patient Safety Champions Reception

Washington, DC
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
(D-TX-29)

Libby Baney and Marty Allain, NABP

Libby Baney and the Honorable Michael C. Burgess, MD (R-TX-26)

Best Practice Sharing Workshop

Paris, France
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.

Read the News Release

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)

Global Health: Access to Safe Medicines Panel

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

Canadian Online Pharmacies Forum

June 5, 2017
Quebec City, Canada

ASOP Global’s Executive Director, Libby Baney, NABP Senior Program Director, Marty Allain, NABP .pharmacy Canadian Consultant, Ronald F. Guse, and Perry Eisenschmid, CEO of the Canadian Pharmacists Association (CPhA) hosted the Canadian Online Pharmacies Forum during the 2017 Canadian Pharmacists Conference, which was co-sponsored by CPhA and the Association of Faculties of Pharmacy of Canada (AFPC) from June 2-5 in Quebec City. More than 700 pharmacists and pharmacy stakeholders attended the conference where they discussed key issues facing Canada’s healthcare system, including the opioid crisis, mental healthcare and antimicrobial stewardship.

ASOP Global Logo

ASOP Global/NABP Canadian Internet Sales Roundtable

May 20, 2017
Orlando, FL

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.

ASOP Global Logo

The Security of the Drug Supply Chain, Patient Safety and Drug Importation

April 28, 2017
Washington, D.C.

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.

Left to right: Ali Schroer, LCSW (a patient harmed by medicine she bought online); Libby Baney, JD (ASOP Global);

John Horton, JD (LegitScript); Elizabeth Jungman, JD, MPH (Pew); John Hertig, PharmD (Purdue College of Pharmacy)

APEC RHSC Regulatory Science Center of Excellence (CoE) for Product Quality & Supply Chain Pilot Program

March 28-31, 2017
Rockville, MD

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.

22nd Congress of the European Association of Hospital Pharmacists

March 22-24, 2017
Cannes, France

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.“

ICANN58

March 11-16, 2017
Copenhagen, Denmark

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.

Read the News Release

International Forum on Patient Safety and Access to Safe Online Pharmacies

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.