The Legal and Regulatory Framework
Pollution laws, such as water, air, and noise control laws and regulations4; laws protecting nature, such as forest and wildlife laws5; and product regulating laws, such as pesticide and labelling laws and regulations, are the three main categories of environmental laws and regulations in SSA.
6 In all three groups, there are similar unifying themes. For example, laws and regulations addressing the three categories can be found in both national legislation and the many international, bilateral, and regional environmental accords to which these countries are signatories. 7 Participation in international treaties enables governments to gain technical expertise, financial assistance, and technical knowledge for domestic environmental programmes. Another common thread is that countries’ constitutions are the major source of environmental laws and regulations. 8 In addition, every country has a designated agency in charge of enforcing environmental laws and regulations.
5 Ethical and Legal Issues
The laws and regulations governing PGD procedures differ greatly from country to country. Most European countries, though there are significant exceptions, prohibit the employment of sex-selection procedures. In Italy, social use of PGD (including sex selection) is forbidden, with exceptions for the protection of the embryo’s health and development; nonetheless, there are precise regulations about whether conditions satisfy those goals. In France, each request for PGD is assessed by the Centre Pluridisciplinaire de Diagnostic Prénatal, which is responsible for determining whether the problems are serious enough to warrant such therapy. Only a few countries’ laws regulate fertility doctors who are licenced to perform PGD. The Human Fertilization and Embryology Act regulates PGD in the United Kingdom (2008). The legislation only allows PGD to be used in circumstances when there is a severe risk to the embryo (serious physical or mental disability, serious illness, and any other serious medical conditions).
Regulatory Environment
Drugs, biological products, and gadgets are all governed by different laws and regulations in the United States. Although the regulations for pharmaceuticals, devices, and biological products have certain similarities, each set of regulations has its own set of reporting criteria, standards, and deadlines, which are based in part on the qualities of the product. Title 21 Chapter 9 of the Federal Food, Drug, and Cosmetics Act (FD&C Act) defines drugs and devices. Biological products, on the other hand, are specified in Title 42 Chapter 6A of the Public Health Service Act. Additional considerations for “human cells, tissues, and cellular and tissue-based products” (HCT/Ps) have been added to these broad guidelines. Articles comprising or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient are defined in 21 CFR 1271.3(d). Title 21 of the Code of Federal Regulations (CFR) contains the relevant regulations.
• Drugs: Parts 200–299 and 300–369 of the 21 CFR
• Parts 800–898 of the 21 CFR.
• Biological products: Parts 600–680 of the 21 CFR
• HCT/Ps: Parts 1270 and 1271 of the 21 CFR