Lesson 10 Assignment
Question One
In most countries all across the world, there are pharmaceutical systems which play the role of developing therapeutic drugs for treating and managing health problems. As a result, there are oversight bodies affiliated with these systems, whose role is to ensure that all drugs newly introduced for consumption by the public are safe. In the United States of America, the main body responsible for this is the FDA, while in Canada, it is Health Canada.
The bodies are charged with the mandate of examining new drugs for the possibility of more harm than benefits when used to manage or treat the target disease or health condition. The bodies also establish, through review, whether the efficacy of the new drug is acceptable and worth ignoring the predetermined possible risks. This factor is sometimes determined by the seriousness of the target illness as well as the availability of a pre-existing remedy for the same.
USA
When a pharmaceutical company in the USA discovers a drug for managing or treating a certain disease, they are required to carry out tests and weigh the reliability of the data acquired. If the data is satisfactory, the company submits an Investigational New Drug application to the FDA. If there is no disapproval after thirty days from the date of submission, the company is allowed to proceed to clinical trials. If the results of the trials are satisfactory in terms of effectiveness and safety, the company submits a new drug application containing all the required information required by the FDA to approve the drug for marketing. If the CDER’s review finds that the drug is effective and safe and its benefits outweigh its potential risks, it is approved.
Canada
In Canada, when a pharmaceutical company wants to develop a new drug, it has to carry out laboratory tests to establish the effectiveness of the drug in treating the target disease. This process involves a study of the disease, its cause and the functioning mechanism of the drug. On acquisition of satisfactory data, an application is made to the HC, which then carries out a review and concludes whether it is okay for the company to go to the next step, which is clinical trials. After the clinical trials, a new drug application is made to the HC, which can then be approved if it meets the required standards. The duration of this approval varies depending on whether the approval is the standard type or priority type. The priority type requires an extra application, and it occurs when the new drug has no predecessor in the market, the disease to be treated is serious, and the new drug has a higher efficacy. This type of application for approval takes a relatively shorter time than the standard type.
Similarities
In both countries, there are two stages of tests and applications by the drug developing company and two review and approval stages by the drug regulatory bodies. The parameters looked at when reviewing the data are also similar for both the FDA and Health Canada.
Differences
Whereas the FDA does not determine the prices of new drugs, the HC sets the prices for the new drugs it approves for availability in the Canadian market. Whereas in the USA, the FDA takes the liberty to determine the drugs which need to be overlooked, for example, those whose target disease has no existing remedy, in Canada, the drug developer has to state whether they are seeking a priority or standard approval.
Question Two
To minimize the use of pesticides and industrial chemicals, the USA and the EU have set up policies and legislations which not only protect the health of human beings but also promote environmental sustainability. This was necessary because companies that had started selling pesticides and industrial chemicals before the introduction of pre-market-approvals were still selling them, and it was impossible to stop them through the law because the new regulations on marketing did not implicate them.
The governments introduced laws which governed the products of such companies to regulate the amount of pollutants released into the environment and those which, in one way or another, come into contact with human beings and animals. These policies promote the use of organic products to fulfil the intended tasks. For example, organic pest control mechanisms are being promoted.
