Generic medicines—chemically equivalent to the patent-expired original brands-- continue to demonstrate they can sharply reduce healthcare costs and make medicines accessible to an increasing number of patients. In the nearly two decades since generics emerged as patents of block-buster originals began to expire, these low-cost medicines have demonstrated their efficacy and safety at par with the originals.
The generics are no longer simply copies of the originals; they are an independent and distinct brand: Accessible Medicines.
Aptly reflecting this evolution, the Generic Pharmaceutical Association, the
U.S. industry group, has changed its name this year (2017) to the
Association of Accessible Medicines.
It is important for healthcare professionals and government agencies to recognize this evolution, that low-cost generic medicines which are as effective as the originals and safe are helping reduce healthcare costs. And, more important, that their affordable costs make them increasingly accessible to patients who couldn’t afford them before.
In its latest report, the trade group estimates that accessible medicines
generated $253 billion in savings for patients and taxpayers in 2016. In the
last decade, the low-cost medicines have saved $1.67 trillion.
Reports from other sources show similar significant savings in the E.U. countries, and in Asia where the governments have mandated increasing use of generics, with Japan the latest country where it is being aggressively implemented.
The expanding markets for the affordable medicines has intensified competition within this segment of the industry, leading to continued price reductions. It is forcing companies like Paradigm to source lowest cost medicines without compromising on quality. The lower prices as a result are a boon for the patient and the healthcare systems.
The contribution of generics to healthcare systems cannot be captured simply in cost savings. Its impact is more telling in the stories of patients who couldn’t afford the medicines before, especially in poor nations of Asia and Africa. There stories abound of people who will tearfully tell you how their loved ones passed away because they couldn’t afford medicines as recently as ten years ago to treat what is now routinely prevented today, high blood pressure or cholesterol.
It is critical that regulators ensure that the patients’ access to medicines is not hampered. Several original companies are modifying their old off-patent formulas and registering them as new. These “new” formulations barely deliver any improved benefits over the older versions. Sometimes the “new” product is nothing but a combination of existing, patent-expired products. This should be a concern because, as history has shown, no matter how good the old drug it loses its standing against the newly patented product that provides little more benefit because the original manufacturers will invest heavily to change physicians’ prescribing habits. This is not all when it comes to threats to generic medicines.
Government agencies must see to it that original companies aren’t actively delaying or preventing generic companies from entering the market with tactics, though legal, that make it harder or less attractive to register and market generics. This is important for low-income countries in Asia and Africa where the local FDAs are reluctant to approve a generic drug that is not already widely marketed in the U.S.
At Paradigm, we believe in profiting by increasing patients’ access to our medicines with affordable prices, and we remain committed to this philosophy as we source quality medicines and balance our business objectives against our social responsibility that comes with being a pharmaceutical company.