Medicines for 25 by 25:legal issues

Professor Amir AttaranInstitute of Population Health

Faculty of Law and Faculty of Medicine

• Medicine price:– Is it patented? Patent law– Is it the purchasing method sensible? Public procurement law

• Medicine quality:– Is it substandard or fake? Criminal and drug regulatory law

• Health-seeking behavior:– Is care universal? Health insurance law

• Prescribing:– Are there sufficient doctors, nurses or other workers? Health professions law– Are the clinical guidelines sensible? Health Technology Assessment law

Four basic issues – all amenable to law reform

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Selection of Essential Medicines First edition 1977

Revised every two years

In 2013 contains 462 medicines including children's medicines

Uses HTA approaches

Patent status NOT considered in selection

Over time has contained 5% to 10% patent protected medicines

• There are 319 WHO Essential Medicines, of which only 17 are patentable:– Antiparasitics: Lariam, Coartem– Antifungals: Diflucan– Antibacterials: Cipro; Zithromax– Antiretrovirals: AZT, 3TC, ddI, d4T, ABC, IND, EFV, NEV, RTV, SQV, NFV, LPV+RTV

• Scope of analysis: 65 countries, all middle and lower income.

• Patent coverage overall is 1.4%. Where patentability existed, inventors used it 31% of the time, but passed on it 69% of the time.

• Patents are found more often in large than small countries, and middle income than low income countries (p < 0.05). A bigger market begets more patents.

• These are descriptive statistics of a general nature. Note specific countries and specific medicines can have much higher patent burdens.

WHO Essential Medicines: patent situation (2003)

Source: Amir Attaran, Health Affairs (2004)

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Fixed-dose combinations and patent landscapes• Simplified therapies are a public health necessity. Nonadherence can increase death

risk by 250%. – Stavudine (BMS) - very few patents– Lamivudine (GSK) - many patents– Nevirapine (Boehringer Ingelheim) - many patents

d4T + 3TC + NVP (patented in 46 or 65 countries)

• But there can be patents on coformulation technologies and trademarks too.

or++

Sanz 2011; DOI: 10.1007/s12170-010-0135-3

Ratios Of Compulsory Licensing (CL) To International Procurement Prices For Antiretroviral Drugs.

Reed F. Beall et al. Health Aff 2015;34:493-501

©2015 by Project HOPE - The People-to-People Health Foundation, Inc.

Fake ARVs bought by Medecins Sans Frontieres: Nairobi, Kenya

Bad quality antimalarials

NLA.13 Abstract (Atorvastatin Generics Study) Publishedin the Journal of Clinical Lipidology, 2013

R.P. Mason, et al., J. Clin. Lipidol., 2013; 7(3):287.

Convention on International Civil Aviation (Chicago Convention)Convention for the Suppression of Unlawful Acts Against the Safety of Civil AviationConvention for the Suppression of Unlawful Seizure of Aircraft (Hague Convention)

TRIPSPatent Cooperation Treaty

Various Free Trade agreements

Unlawful Interference Compensation ConventionConvention on the Marking of Plastic ExplosivesTokyo ConventionWarsaw ConventionParis ConventionParis AgreementHague ProtocolBeijing ProtocolCape Town Convention

Convention on International Civil Aviation (Chicago Convention)Convention for the Suppression of Unlawful Acts Against the Safety of Civil AviationConvention for the Suppression of Unlawful Seizure of Aircraft (Hague Convention)

Unlawful Interference Compensation ConventionConvention on the Marking of Plastic ExplosivesTokyo ConventionWarsaw ConventionParis ConventionParis AgreementHague ProtocolBeijing ProtocolCape Town Convention

TRIPSPatent Cooperation Treaty

Various Free Trade agreements

Guess which is safer?

Law can facilitate, or obstruct.

The law can always be made to fit.

aattaran@uottawa.ca