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Article Case Law Essays Article Case Law Essay Article Case Law Essay University of Phoenix| Article/Case Law Search Paper| Tuberculosis-Critical Regulatory Issue| | | July 19, 2010 Article/Case Law Search Paper A critical regulatory issue in health care is a really broad subject and will always be discussed and debated on. According to The Centers for Disease Control and Prevention, â€Å"TB is an airborne, communicable disease caused by infection with the bacterium Mycobacterium tuberculosis. Infection occurs typically when a person inhales microscopic droplet nuclei containing viable bacteria, usually acquired as a result of droplet nuclei spread through coughing or sneezing by persons who have infectious TB. (Brennan, 2007) Despite the inception of modern treatments and public health interventions, tuberculosis (TB) remains a significant public health threat in the U. S. and abroad in the twenty-first century. The challenge of controlling TB in its traditional and new multidrug-resistant forms requires public health agencies at the federal, tribal , state, and local levels to develop and apply new tools. Among these tools is the use of law in support of efforts to effectively control cases of TB. In May of 2005, the World Health Organization initiated for Vaccine Research. This research was arranged to develop into a meeting of regulators, investigators, and clinicians from different countries that are in the process of developing or countries that have already been developed. Their main cause was to initiate tuberculosis vaccine regulation and research. The discussion that was made in this assembly was of the regulatory challenges for testing and introducing investigative TB vaccines into country where the disease is widespread. A particular focus of this meeting was a discussion among representatives of regulatory authorities from the Developing Countries Vaccine Regulators Network (DCVRN) with those of the United Kingdom and the United States about the important challenges that each regulatory agency will need to address if effective new TB vaccines are to be registered in their countries. The DCVRN is a new WHO initiative establishing a network of vaccine regulators from nine countries: Brazil, China, Cuba, the Republic of South Korea, India, Indonesia, the Russian Federation, South Africa, and Thailand. It provides a forum for discussion, advancement of knowledge, and exposure to policies and procedures pertaining to evaluation of clinical trial proposals and clinical trial data. † (Brennan, 2007) As new and improved vaccines are created, it is a huge benefit for those countries that are in need of the vaccine and the outbreaks that they experience very frequently. Regulatory authorities in developed countries may come into a problem with lack of adequate experience with the disease burden of the target and other associated diseases. Also, these regulatory agencies may be unfamiliar with the medical treatment norms in countries with a high number of people who have TB. Given that there are these difficulties, there would be a huge beneficial to the TB community if there was partnership between regulatory authorities worldwide. There are many things that need to be addressed during the development of effective new TB vaccines. The things that need to be addressed are the preclinical and clinical portion of development. Clinical practices that address the challenges need to be established for the regulatory agencies involved in new candidate TB vaccine development. Such practices should be part of building the regulatory capacity in these countries while addressing the different risk/benefit perspectives that are appropriate for disease-endemic countries. † (Brennan, 2007) Reviewing the results conducted to determine where the need of TB vaccines is considered necessary most in each region is crucial. The determination will help Scientists and Doctors know which Country they must resort to in testing for that region. With all the screening of individuals across the world and new tests being conducted every day, TB has become according to The Centers for Disease Control and Prevention (CDC) – through its Division of Tuberculosis Elimination (DTBE) and its Public Health Law Program (PHLP) – has identified TB to be a major global health problem. Legal preparedness has been established to help control the many public health threats, including TB. Benjamin, Moulton 2008) Despite significant efforts in many jurisdictions to enhance legal preparedness for TB control, legal issues continue to arise. These issues may stem from the application of existing TB and other communicable disease control laws that are dated, incomplete, or vague. (Gostin, Burris, Lazzarini 1999) In other instances, reliance on general communicable disease laws creates potential for litigation because they do not always provide sufficient guidance on how to balance individual rights with public health measures designed to control TB. Even with the numbers growing with this horrible disease, our Scientists are very determined to make sure all tests and individuals are protected by law. It is very important that one may continue to track, update, and inform the Scientists of the laws to protect the testing being conducted and to ensure that everyone is receiving the appropriate care. One may believe that there may be a cure for the millions of people across the world affected with this disease, and we must let the opportunities of the testing continue in order to see the results. References Benjamin GC and Moulton AD. Public Health Legal Preparedness: A Framework for Action. Journal of Law, Medicine amp; Ethics 2008; 36(S1): 13-17. Brennan, Michael J. August 2007. Development of New Tuberculosis Vaccines: A Global Perspective on Regulatory Issues. Retrieved from PLOS Medicine. ncbi. nlm. nih. gov/pmc/articles/PMC1939860/#box2 Gostin LO, Burris S, Lazzarini Z. The Law and the Public’s Health: a study of infectious disease law in the United States. Colum. L. Rev. 1999;99:59-128.