Medicine access in 2010: the Earlier Access Scheme hopes to shorten the waiting period

Not many of us are altogether satisfied with the issue of medicine regulation and access in our country, no matter where in the world we reside

. Healthcare is a hot topic in nearly every country around the world and many countries are continuously trying to upgrade and improve their healthcare system as well as makes medicine access more readily available to individuals who need them. Getting access to medicine can be a long and frustrating process, especially if the medicine has not yet been approved or gone through the stringent approval process. Regulatory affairs are improving but in many instances, medical products are needed immediately for critical patients and there have been problems in the past, especially in the UK over the immediate access of these medicines There seems to be hope on the horizon for UK individuals who are need immediate access to their medicine and who are still waiting for approval. The Medicines and Healthcare products Regulatory Agency (MHRA) are hoping to improve the matter and get critical medicine to people who need it immediately. The MHRA are now beginning a public consultation on proposals that will hopefully make access to medicines that are not yet licensed but can be made available to ill individuals. This scheme known as the Earlier Access Scheme hope to have their proposal approved by the latter part of this year and this would help individuals who are terminally or seriously ill and have limited medication options. Some of these medicines that are still waiting to be officially licensed could be potentially lifesaving for the people who need them and this is where Earlier Access Scheme hopes to help. If this new approval is granted, it could get medicine to individuals who need it up to one year before it is supposed to be released. The scheme is not set to change the overall regulatory regime and will be implemented in order to let the public have access to any new medicine which could improve their way of life. There has been some development in this issue in previous months as the Ministerial Industry Strategy Group (MISG) asked the MHRA as well as Association of the British Pharmaceutical Industry (ABPI) to formulate a framework for consideration. Since then, the MISC has approved the frame work and this means a huge step in the right direction in regards to quicker access to medicine. Once approved, the scheme will allow medicines that have completed Phase III trials to be available. As with all health economics issues, there has been much debate on this issue with many saying that the regulatory process is there for a reason. If it is passed, it will be up to the developers to decide, and their last word will result in their medicine being included or excluded from the scheme. So, now all we have to do is wait and see if this scheme will be approved and if companies will take to the idea of approving medicine access that is not yet fully licensed.

Medicine access in 2010: the Earlier Access Scheme hopes to shorten the waiting period

By: Lauren Potgieter

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