Medicines on the net – risks and benefits

16 November 2009 - A Workshop on Security in Sharm el Sheikh, Egypt

Agenda

“Internet Governance – Creating Opportunities for all”

The topic of how to control the risks of advertising and offering for sale on the Internet counterfeit and other illegal medicines is at the core of the IGF mandate, paragraph 72 of the Tunis Agenda, in particular items 1,2,7, and 11 , and the 2009 conference programme paper, chapter II programme, paragraph 8, item 2,Security:

The workshop presents policy options related to key elements of Internet governance fostering internet security and helps to find solutions to the issues arising from misuse of the Internet which are of particular concern to everyday users.

• The global nature of the Internet makes it an excellent medium to promote health literacy but also to publish misleading information or to market harmful healthcare products, 
• Consumers perceive convenience in buying medicines and healthcare products via the Internet: low prices, discounts, early access to medicines, in remote areas, easier access and privacy, 
• There are countless illegal offers of medicines via the Internet, many of them counterfeit , 
• Often, Internet users are not aware of the risks posed by those illegal offers or do not know how to avoid risky offers of medicines on the web, 
• As a result of illegal offers, consumers may suffer serious damage to their health, financial loss and attacks of cybercrime,
• Quality and safety standards for mail order trade in medicines which promote patient safety and the quality of the delivered medicine are not harmonised at international level, 
• There is no harmonisation in international law, including adequate sanction of the offences relating to counterfeiting of medicinal products and similar crimes threatening public health. 

The workshop organisers, the Council of Europe European Directorate for the Quality of Medicines & HealthCare (EDQM) are bringing together workshop panellists with regulatory, law enforcement, industry (international pharmacy) background and a representative from an international patients’ association from Europe, Asia, North-America and Africa.

The Council of Europe promotes the fundamental right of citizens to have access to information on health issues, and contributes to combating the threat from counterfeit and illegal medicines and healthcare products offered on the web from different perspectives some of which are presented at the workshop: standards and practical measures promoting public health protection and health literacy, the quality of medicines and healthcare, and the co-operation of states in the criminal law sphere. 

The mission of the European Directorate for the Quality of Medicines & HealthCare (EDQM) is to contribute to the basic human right of access to good quality medicines and healthcare, and to promote and protect human and animal health 

The Council of Europe is preparing an international binding legal instrument against counterfeiting of medical products and similar crimes involving threats to public health, a Council of Europe convention, focusing on public health protection. Council of Europe conventions can have a worldwide impact, because they can in principle be joined by interested states. 



1. Council of Europe contribution to IGF

Overall objective 

“…By drafting treaties and setting standards on the internet, the Council of Europe seeks to secure peoples’ enjoyment of a maximum of rights and services, subject to a minimum of restrictions, while at the same time seeking to ensure the level of security that users are entitled to expect . The concrete and practical Council of Europe responses to internet governance issues mentioned later can significantly contribute to the development, sustainability, value, robustness and security of the internet …”

2. Workshop proposal

2.1 Concise formulation of the theme

The workshop deals with health protection of the internet user from counterfeit medicines and other illegal offers of pharmaceuticals via the internet through empowerment of the internet user, sharing of best practices and regulatory policies, and legal instruments for combating counterfeiting of medicinal products and similar crimes threatening public health , where necessary.

The quality of medical counselling and pharmaceutical products obtained via the internet cannot be taken for granted; they could entail considerable risks. Moreover, criminal activities concerning the production, distribution, and use of medicines and healthcare products (including counterfeit and illegal medicines and healthcare products) are widespread and the internet is frequently misused for these purposes. 

The Council of Europe aims at counteracting the advertising and selling of illegal medicines and healthcare via the internet through specific policies and legal instruments, improving patient information , the quality of healthcare that can be obtained online. 

The Council of Europe envisages preparing an international binding legal instrument against counterfeiting of medical products and similar crimes involving threats to public health, a Council of Europe convention . The current work is focused on protecting public health. Often, offences associated with counterfeiting of medicines, distribution of illegal medicines are committed with the help of the Internet. The current work is focused on protecting public health. The impact of the convention would be enforced by existing Council of Europe international treaties in the field, namely the conventions dealing with international co-operation against cybercrime and corruption. (Essential relevance of the theme, see Appendix) 

3. Organiser of the workshop

The EDQM, DBO, and the Criminal Law Division are organising the workshop in particular in co-operation with public health authorities, and organisations and associations active in the field such as: consumers’/patients’ associations, and international associations of the pharmaceutical production and distribution chain. . 

It is envisaged to consult with these partners as regards panellists’ interventions. 

Geographical, gender, multisectorial and multiprofessional representation of stakeholder groups and speakers will be ensured as far as feasible in the frame of a workshop.

4. Workshop concept
Duration: 90 minutes.
The moderator will introduce the workshop topics and moderate the discussions between the audience and the panellists. Panellists’ contributions will set the scene for the discussion.

Moderator: Mr Hugo K. BONAR, Irish Medicines Board. The moderator will also contribute to the topics (1) and (3). 

Topic (1): “Medicines on the net – risks and benefits” 

Panellists: Mr Paul ZICKLER, MD, CIPA (Canadian International Pharmacy Association); 
Mr Hugo K. BONAR, Irish Medicines Board

The panellists will highlight certain aspects of benefits and risks associated with buying medicines via the internet to fuel the discussion on whether and how the safety of medicines on the web can be guaranteed.

Topic (2): “Can consumers and patients benefit from medicines on the web”

Panellists: Mr Kin-ping TSANG, International Alliance of Patients Organizations (IAPO); 
Mr Griffith MOLEWA, National Department of Health, South Africa 

The panellists will outline the needs, expectations of consumers/patients as regards information about and supply of medicines via the internet. In addition, the experiences and approaches of a public health authority with public perception of medicines on the net, consumer education, information, and risk communication, will fuel the discussion. 

Topic (3):”Policies and legal instruments that support patient safety and cyber-security” 

Panellists: Dr Nico KIJLSTRA, Health Care Inspectorate Dutch Ministry of Health, Welfare and Sport; Mr Hugo K. BONAR, Irish Medicines Board

The panellists will present certain legal approaches, such as regulatory policies including safety and quality standards, and international legal instruments facilitating combating crime at international level: this will include Council of Europe legal instruments which are intended to support internet user’s freedom of choice by deterring cybercrime, counterfeiting of medical products and similar crimes threatening public health.


5. Previous experiences

The Council of Europe organised in the frame of the theme “Citizen security”, UN IGF 2007 Rio Conference, the presentation “Illegal vs. legal trade in medicines via the internet”, speaker Dr. Seeberg-Elverfeldt, Federal Ministry of Health, Germany. 

The presentation generated considerable interest. The submission of a workshop proposal for the 2008 Hyderabad IGF Conference was encouraged. 

The Council of Europe organised the international 2005 Seminar on counterfeit medicines and the 2006 conference “Europe against Counterfeit Medicines”. Both conferences were international and with multi-stakeholder participation. 

6. Relevance to the Tunis agenda

Medicines’ supply over the internet impacts strongly on health in general and on citizen security: the Tunis agenda mentions “health” in Action line C7, in paragraphs 23 f) and l), 90 g) and “security” in Action line C5 and in paragraphs 39, 42, 45, 57, 58, 68 and 72

The moderator, Mr Hugo BONAR, will introduce the workshop (WS) topics and moderate the discussions. Panellists’ introductory contributions will set the scene for the discussion. 

Workshop (WS) Moderator and Speaker of the WS topics (1) and (3):
Mr Hugo K. BONAR, Irish Medicines Board
Earlford Center, Earlsford Terrace
Dublin, 2 Ireland
He is the Enforcement Manager, Irish Medicines Board, since 2000, having been recruited to establish the enforcement facility for medicines and medical devices in Ireland. He has been involved with anti counterfeiting of medicines initiatives since then. In particular he is a former Co-Chair of the former Council of Europe’s Ad Hoc Group on Counterfeit Medicines (2005-2006), currently is an expert member of the Council of Europe Group of Specialists on Counterfeit Pharmaceutical Products and was the Chair of the Organising Committee of the Seminar “Counteract the Counterfeiters: Limiting the risks of counterfeit medicines to public health in Europe by adequate measures and mechanisms”, Strasbourg, September 2005. He is the Chair of the Heads of Medicines Agencies Working Group of Enforcement Officers in the European Union and is a member of the Management Committee of the Permanent Forum on International Pharmaceutical Crime (PFIPC), which advises WHO/IMPACT Enforcement on its enforcement nitiatives. He is a qualified lawyer and a former army officer. WS Topic (1): “Medicines on the Web – Risk or Benefit?” Mr Paul ZICKLER, MD, CIPA (Canadian International Pharmacy Association) #2001-1795-132nd Street
Surrey, BC Canada V3W 1J8
EDUCATION
University of Western Ontario, London, Ontario 1965-1972 B.A. and M.D.
Interned at the Royal Columbian Hospital, New Westminster, B.C. 1972-3
WORK EXPERIENCE
• Emergency Physician at the Royal Columbian Hospital for 18 years.
• General Practitioner, owner and manager of three walk-in clinics and two travel
medicine clinics for 12 years.
• Co-founder and owner of Doctorsolve Health Care Solutions since 2000 to present.
• Founding member of CIPA, the Canadian International Pharmacy Association
• President of CIPA 2008
RELATED EXPERIENCE
• Chief Emergency Physician from 1975-77
• Head of Professional programs for the Justice Institute of British Columbia
[ambulance training program] 1979-1986 and while there, developed the Advanced
Cardiac Life support and the Basic Cardio-pulmonary Resuscitation training
programs for the province. During this time served as the chair of the Canadian
Heart Foundation ACLS committee.
• Assisted in developing the Advanced Trauma Life Support training program and codeveloped
the Community Trauma Management Course.
• Our Emergency Physician group at the Royal Columbian Hospital was instrumental
in getting helmet and seat belt legislation passed in the province as well as
establishing Emergency Medicine as a specialty program in Canada.
While at the medical clinics – Peninsula, Glover and Crossroads Medical Clinics
was involved in many pharmaceutical clinical trials, including clinical trials with
vaccines, as both a principle and associate investigator.
• While at the clinic near the American border started seeing American patients to
obtain their medications in 1999 .As the public became more aware of the savings
and the demand stressed the management of the clinic, our group opened the first
office for Americans only in Canada. However, when 9/11 occurred and there was
no traffic across the border we seized the opportunity of the FDA using their
discretion in allowing medications to be mailed and our online presence overtook
the demand of our clinic.
• DoctorSolve Health Care Services in 2000 emerged and we have continued in this
business stressing safety above all else for our patients in obtaining affordable
medications.
MEMBERSHIPS
· Canadian Medical Association
· Canadian Medical Protective Association
· British Columbia Medical Association
· British Columbia College of Physicians and Surgeons
· British Columbia International Pharmacy Association
· Canadian International Pharmacy Association
WS Topic (2): “Can the consumer/patient benefit from medicines on the net?”
Mr Griffith MOLEWA, National Department of Health, South Africa
Manager Law Enforcement
Medicines Regulatory Affairs
Private Bag X828
Pretoria, 0001
South Africa
He is a pharmacist by profession having worked in industry for 30 years. His career span includes being an Analyst, Quality Assurance Supervisor, Production Pharmacist, Packing Managing (Smith Kline & French); Materials Manager (Pharmacia and Upjohn), Logistic Manager (Avon Cosmetics), Production Leader (Aspen Pharmacare) and law Enforcement Manager (Department of Health). He also has some short curse certificates on Financial Management, Production Management, and Quality Management. In his current position, he is overseeing the following projects: Counterfeit in Medicines, working closely with local and international law enforcement agencies. Monitoring the importation of psychotropics and narcotic drugs following INCB guidelines. Monitoring and controlling API’s that could be diverted to manufacturing of illicit drugs.
Formulating policies that will regulate cyber-pharmacies. Mr Kin-ping TSANG, International Alliance of Patients Organizations (IAPO) President
Retina Hong Kong
No. 101, G/F, Lai Huen House
Lai Kok Estate, Kowloon
Hong Kong
Mr. Kin-ping Tsang, a retired business executive, is affected by Retinitis Pigmentosa that brings him with severe visual impairment. He has founded Retina Hong Kong (RHK), a patients’ self-help organisation with fellow partners in March, 1995 and serving as President of RHK since then. He was elected Member of Executive Committee of the Alliance for Patients Mutual Help Organizations (APMHO) in Hong Kong in 2003 and was appointed as Secretary in 2005. His major tasks are helping the Alliance to consolidate its internal management and develop external networks. He retired from APMHO’s board in August, 2007 and has been appointed as Honorary Secretary to help the Alliance to take part in international affairs. Mr. Tsang has been elected to the Governing Board of International Alliance of Patients Organizations (IAPO) in February, 2008. He was Member of Management Committee of Retina International from 2000 to 2006. He has been serving the Board of AMD Alliance International since 2006. WS Topic (3): “Policies and legal instruments that support patient safety and cyber-security” Dr Nico KIJLSTRA, Health Care Inspectorate, Ministry of Health, Welfare and Sport, the Netherlands Pharm.D., Senior healthcare inspector Health Care Inspectorate Ministerie van VWS
P.O. Box 392
NL-8000 AJ ZWOLLE
He (1962) studied pharmacy and public administration. He has working experience in public and hospital pharmacy and was part-time assessor of applications for marketing authorisations for the Medicines Evaluation Board. In 1996 he joined the Health Care Inspectorate, a public supervisory service and enforcement agency in the Netherlands. There he had several assignments, such as head of the section for pharmaceutical care (2002). At present his main responsibilities are the co-ordination of supervisory activities regarding the use of medicines and the quality of pharmaceutical care, chairing the monthly meetings of the spectors involved. He is responsible for several projects in the field of medication safety and performance measurement in healthcare, all related to the safe and effective use of medicines. He has been involved in the subject of medicines and Internet since 2002, e.g. as a member of the Ad hoc working group on mail-order of medicines of de Council of Europe. He regularly inspects e-pharmacies. Currently he is Vice-chair of the European Committee on pharmaceuticals and Pharmaceutical Care, and Chair of the Committee of Experts on quality and safety standards in pharmaceutical practices and pharmaceutical care, under the egis of the European Directorate for the Quality of Medicines and Healthcare, Council of Europe, Strasbourg.