Laws and regulations controlling pharmaceutical industry play an important role in addressing healthcare concerns impacting human population. Considering safety concerns pertaining to patients and involvement of many stakeholders (like patients, health providers, pharmaceutical companies and drugs retailers and wholesalers) in healthcare industry, it becomes essential to have realistic and effective laws and regulations. Having effective laws become even more important considering that consumers do not have the ability to assess safety, efficacy or quality of pharmaceutical products.
Technological developments have been a boon to the pharmaceutical industry but not without challenges. The Internet makes it difficult to control deceitful drug promotions. Counterfeiting has been on the rise, and in the absence of an international regulatory body it has become difficult for pharmaceutical companies to check the counterfeiting threat. Digitalization of healthcare, which enables collection and exchange of vital healthcare data, has opened up the industry to new regulatory and cyber security challenges. Increasing data security issues pertaining to digitization of healthcare industry demands introduction of effective regulations.
With the development of telemedicine, mobile health, Integrative medicine, health-related nanotechnology, concierge medicine and robotic surgery, role of legal / regulatory authorities to safeguard interests of public health has increased. The influence of 3D printing in medical equipment and healthcare device manufacturing will encourage Food and Drug administration (FDA) to make amendments to its Section 510 regulations.
Other than safety, regulation of drug prices is also emerging as a major concern in healthcare business. Large pharmaceutical companies are charging higher for many speciality drugs, which has resulted in them getting into legal disputes with government authorities. To counter the higher drug prices most of the countries have price ceiling in place for many speciality drugs which are governed by various regulations.
ASDReport.com has a good collection of reports on legal/regulatory aspects pertaining to pharmaceutical and healthcare industry.