The 5000% increase in price in the US for an off-patent drug by a company with a monopoly license was widely reported yesterday.
This was based on a very good article on Monday 21 September in the New York Times. 
The least interesting aspect of the story however, is the company responsible for increasing the price and it’s noxious CEO. The real story is that the US has a system that allows this to be legal – and that the US is driving new trade agreements that threaten similar restrictions globally.
The story relates to a drug called pyrimethamine that has been off patent for decades. This is an important drug. It is used to treat toxoplasmosis which affects people with suppressed immune systems (transplant recipients, and HIV positive people) but also women during pregnancy (irrespective of HIV and immune status) and children who are infected with toxoplasmosis at birth.
However, most of the story is about US-access and is US-based. It relates to a regulatory and licensing system that allows any single manufacturer to have a license for a drug that is already off patent. The NYT article referred to other widely used off-patent medicines that have undergone similar monopoly-based investment pricing, including the antibiotics doxycycline (multiple use, including STIs) and cycloserine (for drug resistant TB). This is about a broken system that needs fixing.
It raises issues about:
- Monopoly licenses and importance of competition for drug pricing.
- How monopoly licenses can be granted for off-patent drugs.
- Monopoly licenses to drugs on the WHO list of Essential Medicines for citizens of all countries. Pyrimethamine is listed as an essential medicine for both adults and children to treat pneumocystosis, toxoplasmosis and malaria. 
- Use of online pharmacies to import generic medicines for personal use. This is perfectly legal in many high income countries, including the UK, if this for personal use, irrespective of drug patent. 
- Lack of any regulation between drug approval and drug pricing. For any drug, in-patent or off-patent, the manufacturer can set any price that the market will pay.
For people in the US, the option to access import generic medicines for personal use should also be available. US citizens widely use Canadian and other online pharmacies, although this may complicate reimbursement costs for those on insurance-based care. But while access to online suppliers might overcome the short-term cost issue for individuals, this probably excludes health providers who will be stung by monopoly price increases. A challenge to the license should therefore be an advocacy issue strengthened by the option for public health providers to also be able to do this for their patients.
From the 1970s, the Indian generic manufacturer Cipla led generic access to medicines for 90% of the worlds population living in low and middle income countries. As with other generic companies, Cipla are a for-profit commercial company and they list pyrimethamine as one of their current products. Based on the cost of co-forumated pyrimethamine plus sulfadiazine at less than $0.45 a tablet from online suppliers, the earlier US price of $13.50 a tablet seems steep even prior to the hike to $750. [4, 5]
This story highlights the risk for monopoly licenses for medicines in any situation. It especially highlights the risk for medicines that are off-patent, without linking this to a requirement for pricing. The move to further strengthen and restrict global patents for medicines has been an ongoing concern for at least the last decade.
For people outside the US, this news story on pyrimethamine might appear to have little direct impact – so long as generic manufacturers continue to manufacture pyrimethamine, including as a separate drug. Most use for pyrimethamine however is in a two-drug coformulation of pyrimethamine plus sulfadiazine in a single tablet, which is still widely available from many generic manufacturers. 
But the continued access to generic medicines outside the US, including in the EU, is directly threatened by proposed changes to EU legislation - the Transatlantic Trade and Investment Partnership (TTIP) - that would extend and strengthen patent rights globally for all medicines. [7, 8, 9, 10]
Given that 65-85% of all prescribed medicines in the UK are generic, fighting to retain access right to medications is an issue that does and will affect us all.
Check out the links below to the MSF Essential Medicines campaign. This is an issue for people in the UK.
Late on Tuesday, Martin Shkreli, founder and head of the small opportunistic Turing Pharmaceuticals, and personally linked to the PR mess that generated his widespread vilification, announced that the price would be lowered.
This does not reduce the future vulnerability of people to similar practices in the US.
BOX: Pyrimethamine use to treat toxoplasmosis in the UK 
- Active toxoplasmosis in HIV positive people is treated with a few months of pyrimethamine and sulfadiazine dual treatment – which generic suppliers currently list at $0.45 for a 25mg/500 mg tablet, or $55 including shipping for 100 tablets. This is likely to mostly affect people who are diagnosed very late when the CD4 count is less than 100 cells/mm3.
- Pyrimethamine and sulfadiazine are also used during pregnancy in women who become infected with toxoplasmosis during their pregnancy, if the infection is likely to have reached the baby.
- Congenital toxoplasmosis in new born babies is treated with pyrimethamine and sulfadiazine for at least a year.
This article was updated on 23 September with a postscript on the decision to change the price, and for light proof editing.
References and links
- Pollack A. Drug goes from $13.50 a tablet to $750 overnight. New York Times. (21 September 2015).
WHO list of Essential Medicines (2013).
- i-Base Q&A. Where can I buy PrEP or HCV meds online and is it legal in the UK? (15 September 2015).
Cipla Limited. Current product list. Accessed 22 September 2015.
Pharmacychecker.com. Pyrimethamine/sulfadoxine 25 mg/500 mg. Accessed 22 September 2015.
- NHS. Toxoplasmosis treatment: Pyrimethamine/sulfadoxine 25 mg/500 mg. Accessed 22 September 2015.
- Médecins Sans Frontières access campaign. TRIPS. TRIPS Plus and Doha. (July 2011).
- Médecins Sans Frontières access campaign.
- MSF statement on RCEP Ministerial in Kuala Lumpur. (24 August 2015)
- MSF to TPP Trade Ministers: Don’t create new monopolies for biologic medicines at the “final’ TPP negotiations in Hawaii. (28 July 2015).