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Presentation at the 1st International Symposium on Counterfeit Drugs held at the King Fahad Medical City Riyadh 8-9 April by Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics, Chairman of the Institutional Review Board, Chairman of the Human and Medical Ethics Committee, and Chairman of the Behavior Standards Committee at King Fahad Medical City Riyadh.
4 ETHICO-LEGAL PRINCIPLES
• Four ethico-legal principles guide our handling of counterfeit, fake, or substandard products.
• Intention (qasd)
• Certainty (yaqeen)
• Harm (dharar)
• Customary practice (‘aadat)
COUNTERFEIT: DEFINITION AND LEGAL PROCESSES
• The definition of counterfeit drugs is under 2 principles: intention (qasd) and certainty (yaqeen).
• There is an underlying intention to deceive or misrepresent/misdescribe the drug
• We must have certainty based on empirical standards that there is misrepresentation
• Legal proceedings against counterfeit drugs is under 2 principles: harm (dharar) and customary practice (‘aadat)
• A counterfeit is still illegal even if no specific harm is identified
• Common international conventions (aadat) are needed to combat a wide world problem
DEFINITION OF COUNTERFEIT: UNDERLYING INTENTION
• Origin/authenticity
• Effectiveness
• Concentration
• Diluent or vehicle
• Packaging and labeling
• Benefits/risks
• Purity from chemical and antimicrobial contaminants.
DEFINITION OF COUNTERFEIT: DECEPTION and MISREPRESENTATION
• The definition of counterfeit is more related to the deception and not the infringement of intellectual property.
• The Law distinguishes between misrepresentation with and without a deliberate intention to deceive and prescribes different penalties because many who handle these drugs lack awareness or knowledge
• Low-cost generic drugs or biosimilar formulations are not necessarily considered counterfeits if there is no misrepresentation.
• Falsification of clinical trial data should be treated as counterfeiting.
CERTAINTY IN DISTINGUISHING FAKE FROM REAL PRODUCTS
• Certainty in identifying counterfeit products is hampered by a lack of international consensus on the definition.
• Chromatographical and spectroscopical analyses distinguish counterfeit from standard or genuine products.
• Scientific analysis is relevant to regulate manufactured products and not for unregulated traditional or complementary products.
HARM OF COUNTERFEIT DRUGS
• The harm of counterfeit drugs is discussed under the principle of harm (dharar).
• The harm of counterfeit drugs to health far outweigh any imagined benefits.
• Consumer sovereignty and autonomy to decide what products to buy create problems because of lack of or despite awareness/knowledge of counterfeiting.
• Consumers believe in counterfeit products because of their lower cost, accessibility, and perceived effectiveness that may be a pure placebo effect or due to the small quantities of effective agents.
CONTROL OF COUNTERFEIT DRUGS - 1
• Counterfeiting can be controlled if common standards are adopted at national and international levels so that uniform practices can be enforced under the principle of common customary practice (‘aadat).
• Laws that prohibit and impose severe penalties for manufacturing, trafficking, or selling counterfeit products are difficult to enforce because of e-commerce, black-market, and online pharmacies.
CONTROL OF COUNTERFEIT DRUGS - 2
• Drug registration and licensing, WHO prequalification, and drug licensing are not effective.
• The enormous profits from dealing with counterfeit drugs encourage organized crime.
• Detailed legal maxims No 356-360 and 310-312 explain the handling of transactions involving misrepresentation.