The large graphic accompanying your article (The cost of drugs, 9 April) has a major omission, one of the most important factors affecting medicine pricing and affordability. (There are others involving “international reference pricing” and “parallel trade” but that’s a separate debate.)
It charts the 13 years of rigorous clinical development required by regulators to ensure new drugs achieving regulatory approval are safe and effective. As the article states, all this R&D costs an absolute fortune.
The crucial missing piece is what happens next. Patent exclusivity is limited by regulations enabling other companies to make copies of the original licensed product (within a lot less than the 20 years referred to). Once these “generic” drugs are launched, the originators’ revenues can quickly diminish to next to nothing, meaning that the companies investing in the R&D have a relatively limited window to make their money. With such a relatively short duration to (more than) recoup the costs of investment, drug prices have to be higher than necessary. The issue is even more pronounced for medicines used to treat relatively rare conditions, where the cost per patient has to be necessarily high. If it wasn’t then, simply, fewer new medicines would be made.
I’ve often advocated that if patent exclusivity was extended for two to three years, lower prices would be possible and in everyone’s interest, except those generic companies who’d have to wait a little longer before they could begin sales with their copies, but surely all the risk is being taken by and all the clinical unmet need is being satisfied by the originator. Giving them a few years longer to make sales (at a lower price) seems a sensible compromise, but under the complexity of international regulatory rules, changing such policy is extremely unlikely to happen.
PPi Healthcare Consulting
• I read your article with interest. The World Health Organization and more recently, as you note, the UN, have been clear on the urgent need to improve access to essential medicines globally.
However, your article fails to mention innovative collaborative initiatives to increase supply of low-cost, quality-assured medicines in developing countries.
One such mechanism is the Geneva-based Medicines Patent Pool (MPP). The MPP has been successful in brokering licences with major pharmaceutical companies to allow generic manufacture of new HIV, hepatitis C and tuberculosis treatments for low- and middle-income countries (LMICs). In HIV, for example, the MPP is now working with more than a dozen suppliers to produce UK-based ViiV Healthcare’s dolutegravir. Affordable versions of this novel antiretroviral and new drug of choice in the United States could reach more than 100 developing countries over the coming years.
And as international experts and scientists meet at the International Liver Congress this week in Paris, the MPP will have good news to share with the hepatitis C community. Its licensed antiviral, Bristol-Myers Squibb’s daclatasvir, paired with sofosbuvir, will soon reach many LMICs.
As a result of generic competition, prices for hepatitis C drugs are dropping. Last October, Médecins Sans Frontières announced it had secured a price of $120 for a three-month course of DAC/SOF, a dramatic cut from the original price point for the treatment in 2015.
Chair of the governance board, Medicines Patent Pool
• Your article on the cost of drugs raised many important points, not least the sometime failure of Nice and drug manufacturers to reconcile value with profit. This seems particularly the case where the high cost of drug development is aligned with a relatively small and static client group. In such cases, surely a rich and mature society has a reasonable expectation of its government to set aside political and economic considerations in order to protect the interests of an acutely vulnerable minority. The current debate between NHS England, Nice and the manufacturer Vertex over the funding of Orkambi for sufferers of cystic fibrosis is a case in point. Is it not time for leaders and decision-makers to demonstrate their moral responsibility by acknowledging that one life is as valuable as another irrespective of the size of the client group to which it belongs?
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