On September 29, 2023, Johnson & Johnson (J&J) announced that it would not enforce patents in 134 low- and middle-income countries for Sirturo — its brand name for bedaquiline tuberculosis treatment. This change is an exciting step toward providing generic, affordable tuberculosis treatment to people who desperately need it.
Patents and Medication Prices
Patents can keep the cost of life-saving medications out of reach for many – especially those in poverty. So why do medications have patents? Pharmaceutical companies must undergo a rigorous testing process through the FDA to ensure the drugs are safe enough to go on the market. They obtain a patent to protect their research, which the FDA requires before approval. Once this patent is obtained, pharmaceutical companies must undergo a five-step process:
- Preclinical research.
- Clinical research.
- FDA review.
- Post-market safety monitoring.
More than 90% of drugs do not make the cut — most fail because they either do not adequately treat the condition or because they cause side effects that are too debilitating.
It takes about 10 years for a new drug to complete the five-step process toward FDA approval, costing an estimated $2.6 billion. Considering that 90% of medications are not approved, pharmaceutical companies try to recoup their investment by passing that cost onto consumers. Innovation of new medications used to be the goal of pharmaceutical companies, but with the increased costs of research and development, they shifted their focus from innovating new medications to capitalizing on existing medications. Over the past five years alone, the average cost of medications has increased by more than 71%.
Rising Costs of Medications
Patents prevent the development of generic alternatives to medications. When pharmaceutical companies shifted their focus toward capitalizing on existing medications, they started proactively renewing drug patents to ensure generic alternatives could not be developed. Without competition on patented medications and no federal oversight on drug prices, pharmaceutical companies can set the price of life-saving medications as they see fit.
This decision is particularly devastating for developing countries. Even when generic alternatives are available, research has found that developing and poverty-stricken countries often pay more than others.
“Developing countries are often paying far more for everyday drugs than they should be. Why do some poor countries pay 20 to 30 times as much as others for common medicines to relieve pain or treat hypertension? In large part, because of flawed drug buying practices and broken generic medicines markets,” said Amanda Glassman, the executive vice president at the Center for Global Development.
Without generic medications, affordable health care is out of reach for developing countries, and people are paying the price for their health. Even when generic medications are available, there is little regulation of prices.
Tuberculosis and Poverty
Poverty is a huge determinant of tuberculosis. Tuberculosis risk factors are rampant in the poorest communities: overcrowding, malnutrition, inadequate ventilation and limited general health and disease prevention knowledge.
Given the prevalence of tuberculosis risk factors in poverty-stricken communities, the need for generic tuberculosis medications is a lifeline most vulnerable communities need now more than ever. This need is why Johnson and Johnson’s announcement that they will not enforce patents on their patented TB medication is a step in the right direction. The hope is that this will pave the way for affordable tuberculosis treatment by allowing the development of generic, more affordable alternative drugs.
“The decision is intended to assure current and future generic manufacturers that they may manufacture and sell high-quality generic versions of Sirturo without a concern that the company will enforce its bedaquiline patents, provided the generic versions of Sirturo produced or supplied by generic manufacturers are of good quality, medically acceptable and are used only in the 134 low- and middle-income countries,” J&J said.
– Ann-Jinette Hess