Page 4: Bringing a product to market
Trials take place in three phases.
- Phase I involves the drug being given to 50-150 healthy volunteers to see how it works in humans and help establish the correct dosage. This phase lasts for approximately two years.
- Phase II also extends for two years and tests the drug on a small, probably 100 - 200, number of patients with the condition that is being targeted. The medicine is assessed to determine the dose at which it works and that is does not produce any unacceptable side effects.
- Phase III, the final period of trials extends this to between 500 and 5000 patients and lasts for three years. These clinical trials are absolutely essential to guarantee that the medicine works and that there are no potentially serious side effects.
Providing the safety and effectiveness of the drug can be established by the results of the trials, AstraZeneca can apply to the national licensing authorities for permission to market the drug. Even then, close monitoring of the drug’s performance will be necessary to ensure there are no adverse effects.
The key to AstraZeneca’s programme is the ability to select those compounds with the greatest potential to become significant advances in healthcare in the future. Across the pharmaceutical industry only one in ten candidate drugs will actually make it through the process and on to the market.
No pharmaceutical company would invest £500m in research and development if, as soon as the drug was released onto the market, all its competitors were able to analyse the compounds in their own laboratories, copy them and release their own branded versions at a fraction of the cost of development. It is essential that all the pharmaceutical companies are able to recoup their investment in time and money over a period of time following the drug’s release onto the market. This protection is achieved through the use of patents.
What is a patent?
Rather than try to keep a new compound secret, which is virtually impossible, inventors apply for a patent. This is a form of legal protection that prevents illegal copying. These statutory rights will last for a set period, usually 20 years, after which other manufacturers are free to produce their own, possibly cheaper versions of the drug called generics.
Pharmaceutical companies can apply for patents of the molecules of the new compounds at a very early stage of the research and development process to prevent new discoveries leaking out. Thereafter the company can apply for further patents to protect the development process, the formulation process and even the shape of the tablet or capsule.
Research into new medicines would be unthinkable in an environment without this protection as the company would be unable to recover the original research and development costs. This is an example of the legal system protecting and helping the manufacturer.