Access to medicines 24, 28 Flashcards
Which medicines can be mass produced at low costs?
Hepatitis B medicines - Sofosbuvir/entecavir
HIV drugs - TDF/3TC/EFV
TB drugs
Hepatitis C drugs
How can medicines be cheaply produced?
Cost of Active pharmaceutical ingredient (API) + Formulation + packaging + 13% profit margin + tax
Prices of drugs is much higher than generic cost due to upmarket of pharmaceutical companies
How can patent laws prevent access to medicine?
A patent gives drug companies the right to exclude others from making, using, selling + importing a drug for a limited period of time, usually 20 years therefore can make it extremely expensive.
When patents expire, generic drugs should be available worldwide as close to production costs but few national health services know these costs
Patents are temporary, government-granted incentive for innovation
What are the tools that enable increased access to drugs after patency?
Standard prices - $90 $90 $90 in 2017 - to treat HIV, hep B/C, TB
Pricing transparency (WHO Panel) - EML has costs
Government legislation e.g. ‘All you can Treat’ for Hepatitis C
Compulsory licenses
Buyers clubs
Windfall taxes on tax avoidance
Explain the concept of ‘Buyers Clubs’
A club organised to pool members’ collective buying power, enabling them to make purchases at lower prices than generally available e.g. AIDS buyers clubs obtained meds that were not FDA approved yet; FixHepC buyers club in Australie to obtain generic versions of sofosbuvir, daclatasvir
What should be done to improve access to drugs?
Importation of generics for personal use should be legal across Europe
Generic drug production should be better coordinated across Europe
Is access to medicines a human right?
Yes
Protected by numerous legal obligations
What are the core human rights laws that pertain to ‘access to medicines’? (x5)
Right to life - ICCPR, Art 6
Health is a fundamental human right indispensable for the exercise of other human rights; access to healthcare - ICESCR, Art 12
Access to health care - UDHR, Art 3
The prevention, treatment and control of epidemic, endemic, occupational + other diseases - International Covenant on Economic, Social + Cultural Rights: Art12
To provide essential drugs, as defined under WHO Action Programme on Essential Drugs - ICESCR, GC12
What are the conflicting ideas between pharma research + access to medicines?
Consequence of not being able to access medicine is different to other consumable goods
Access to medicine conflict with trade laws + pressures that limit government action
Give 2 examples of drugs where the NHS refused patient treatment due to high cost
PrEP - TDF/FTC
Cancer Drugs Fund
What are the limits of tiered pricing?
Discounts not steep enough + not as effective as generic competition
No solution to patent barriers for innovation
What are the limits of ‘voluntary’ licenses?
Restrictions limit full effect of generic competition e.g. trade in API, export
Rare + often response to threats of legal action
Give an example whereby a national government tried to overcome patents
India
Patents not granted for new uses or new forms of existing medicines unless demonstrating significant increase in efficacy
Possibility of pre- and post-grant opposition by public interest groups e.g. patients
Why do pharmaceuticals have patents?
Constitute a temporary monopoly but in the end society benefits
What is the monopoly model?
Monopoly model - anti-competitive + no accountability on price setting - HIGH PRICES