The “Compact for Competing in the Pharmaceutical Engineering Industry” is being pushed by the Pharmaceutical Regulatory and Development Authority (PRDA) to be included in the forthcoming revision of the Pharmaceuticals Regulations. A group of companies have been lobbying for the inclusion of the PRDA's Compaq guidelines on grounds that these will help to speed up the drug development process. There is no doubt that the standards set by the PRDA are a highly desirable standard but it seems certain that a voluntary agreement will have to be made by these groups, namely those who have requested an inclusion of Compaq as a technical development tool.
The pharmaceutical industry has consistently voiced its view that its key objective is to speed up the drug development process by implementing what are known as “open-access agreements.” The industry wants to avoid the use of “pay-for-access” arrangements whereby only a few pharmaceutical companies can access important information about the medical devices, reagents and other materials required for drug manufacture. By creating a system that allows all interested parties to access key information, the industry can improve productivity. This, in turn, improves the quality of the finished product.
However, as well as saving time and money, there is a strong case that open-access agreements will also improve the quality of the final drugs. There are two main reasons why this should be the case. Firstly, there is a large amount of data that is not available.
Clinical trial records can be invaluable in helping pharmaceutical scientists to make the correct decisions about a potential treatment. Clinical trials can only be conducted after carefully reviewing the results from past trials. For instance, if one group found that a particular drug proved effective in treating a certain condition, there are high chances that the results from future studies will show the same success.
However, most clinical trial records have been lost due to negligence on the part of the researchers. They may have failed to collect information, either because they were too busy or because they didn't take the time to read through all the trial details. Even if the records were taken down, there are still a number of gaps in the data that the research team has. The failure to include the details of the different treatments, methods used to treat different conditions and so forth can leave a lot to be desired in terms of accuracy.
Secondly, data about the drug itself is often incomplete. For instance, in the United States and in many other countries, the Food and Drug Administration (FDA) requires that the manufacturer provide information on the clinical study results that relate to any drug that has already been approved. This is not always achieved and sometimes the company is not even required to provide any data at all.
As a result, the regulatory agencies have had to use resources such as the US National Library of Medicine (NLM) to gather all the information that they need. It is only through such a process that the regulatory . . . . . . agencies can determine whether there is sufficient evidence to allow the application to proceed. In the case of the PRDA, this task is being accomplished by compiling information from over 30 different clinical trial databases into a central repository. However, the problem of missing data means that the process has taken more time and cost more money.
Given that both of these issues are important, it may be reasonable to suggest that it makes sense to have an open-access agreements included in the revision of the pharmaceuticals regulations. In order to get the best possible standard, a voluntary agreement could be necessary to ensure that the interests of the industry are protected. If a compromise can be made, it may be that this voluntary agreement will ensure that both parties benefit.
