The profit-driven model of pharmaceutical research and development (R&D) is not generating enough new and truly innovative medicines that address priority health needs. Unless a profitable market exists for a medicine, pharmaceutical companies will often not develop it. This has led to a lack of new antibiotics in clinical development, as well as limited treatments for malaria, multi-drug resistant tuberculosis and neglected tropical diseases. In their drive to seek markets that guarantee high prices and quick recovery of assumed investment, originator pharmaceutical companies have shifted focus from needs-driven to market-driven innovation—where aggressive pharmaceutical marketing, wide patenting, litigation against competitors and the development of ‘me too’ medicines earn the biggest profits.
In the rare event that truly innovative new medicines are developed, the current R&D system rewards pharmaceutical companies with extensive monopoly protection in the form of patents and data exclusivity. This prevents generic competition and allows companies to charge monopoly prices that many patients and healthcare systems cannot afford. As a result, millions of people around the world are currently going without needed treatment even though it exists.
To change this, Health Action International presses governments to adopt new models of pharmaceutical R&D that are not driven by excessive intellectual property protection and monopoly prices. We urge them to change the patent system as an incentive mechanism for biomedical R&D because it needs competition and should no longer be the only game in town. We lead the increasingly strong call for further exploration of competing innovation models that de-link the cost of R&D from the price of medicines, such as open knowledge innovation, patent pools and product development partnerships. These models would encourage needs-driven research, rational use of medicines and more affordable access to medicines.