Data exclusivity protects drug manufacturers from generic competitors using their clinical trial results to sell drugs. It adds another layer of regulation to patents and trademarks, but can hinder medicine affordability. Pharmaceutical companies argue it’s necessary to recoup expenses, while generic manufacturers believe it keeps drug prices high.
Data exclusivity is a form of protection available to manufacturers of prescription drugs, preventing generic competitors from using the results of clinical trials performed by the drug developer in their applications to regulatory agencies requesting permission to sell drugs. This protection lasts for a limited time, with the length of time depending on the country. Companies with drugs in development argue that people shouldn’t be allowed to use their study data without paying for it when asking for permission to sell competing generic formulations. Generic manufacturers believe that data exclusivity keeps drug prices high, making it harder for low-income people to access drugs.
Clinical trials are expensive and can take a long time. Companies invest a lot of time and money into these studies to determine if a drug is safe and to find out what conditions it can treat. Pharmaceutical companies may treat this data as proprietary, because it pertains to the brand-name drugs they manufacture, and they want to reclaim the drug discovery and research process.
Companies can already obtain patents to protect sales of their drug for a specific period of time. Data exclusivity adds another layer of regulation. Generic drug companies may know that their drugs are safe from original clinical trial results, but they can’t rely on those results when they go to regulators for permission to manufacture and sell their drugs. They have to run their own tests or wait for data exclusivity to expire so they can turn to finding the original company.
This is a form of patent and trademark protection. For pharmaceutical companies, drug development is very expensive, and many of the compounds in which pharmaceutical companies invest never make it to clinical trials, let alone the open market. If a competitor can benefit immediately from its research and sell a generic version at a lower price, the original company will have difficulty finding buyers for the drug and cannot hope to recoup the expenses associated with producing it.
People concerned about the affordability of medicines in developing countries and low-income communities argue that while patent protection and tools like data exclusivity are reasonable, they can hinder medicines affordability. Some people can’t afford to pay list price for brand-name drugs and may lose access to treatment, when a drug company could make a drug-identical generic and offer it at a lower price. These patients either have to wait for the drugs to expire off patent or hope that a drug company can negotiate a special license to produce generic drugs for use in a specific region.
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