45 microsoft powerpoint - generic vs brand
Generic name: the name of the main ingredient of a product. Often similar across a drug group (PIs, penicillins).
Brand name: name chosen by each company producing the product. Often more memorable and easier to say.
Under patent (~20 years from product registration)
Advantages: quality guarantee; encourages research and development of new products within same regulated system.
Disadvantages: expensive – need to recoup costs of years of development AND make a profit.
Health vs. business – a politically charged issue. WTO: access to medicines should be treated differently from other patent issues in order to protect public health interests.
FDA: A generic must have the same indications, strength, purity and quality as the original product. It must be prepared in the same formulation and be bioequivalent. A copycat…Advantages: competition! Encourages cheaper pricing and increases access.
Allows fixed dose combinations.
Disadvantages: resource poor countries may not have capacity to do prerequisite quality assurance. Risk of counterfeit products.
Addressed to some extent by the WHO…pre-qualification system
quality. Recent removal of generic products
as bioequivalence trials did not meet
standards of GCP.
Trade Related Intellectual Property (TRIPS)
consumption without permission of license holder (compulsory licensing / patent waiver). Used by Brazil, India.
2003: hotly contested statement allowing waiver of 2001 rule that generics must be for use in country of production only.
Now wide purchase allowed – parallel importation!
But: The US demanded that only the poorest should benefit…fears of re-importation to US.
Countries like Mexico, Hong Kong and South Korea promised to use this waiver of patent rule only in times of national emergency.
Balance of need vs. intellectual property
Dutch: recalled 35000 packages 3TC / combivir resold in EuropeDiflucan® siphoned from Ugandan clinics and resold…
So… change packaging; mark clearly “not for resale”.
Is there an option? $250 per annum for 1st line therapyReduction in cost and free medication results in increased access (SA >5 million, Kenya 2.2 million people need ART) and improves adherenceCombination tablets are convenient and efficacious
India (Narang et al, J Clin Pharmacol 2005): 24 HNV, randomised to d4T, 3TC and nevirapine as brand name or as triomune.
Kuramasamy et al, AIDS 2003. Same efficacy in India.
Cameroon (Laurent et al, Lancet 2005) showed good drug quality and same efficacy (80% VL <400 copies/ml at 24 weeks)
South Africa – Gugulethu (use a mix of generics –d4T, NVP - and brand – 3TC, EFV) 93 – 97% of cohort have VL < 400 copies/ml at all time points to 32 months.
Need to think laterally about new drug development.
Encourage post-marketing surveillance.
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