Introduction
Governments in the U. S and U.K have empowered some institutions in their countries to regulate and ensure proper and quality availability of drugs. These regulations have led to research on the regulatory methods on various products. The survey results done by different researchers show that in the U.K drugs are approved faster compared to the United States of America. Many researchers have concentrated on the number and the speed at which new products are dispatched in the markets of these two countries (Abraham, 1995). However, some researchers indicate that there is some comparison in the way regulation of drugs is done in these countries. It is important to note that the comparative data of the regulatory outcomes obtained does not offer enough evaluation of the regulatory process and assessment. But this scientific judgment and research are of great significance to society because the public can understand and make a proper judgment on the process of public health protection and drug regulation performance. The citizens of a country can know whether a certain agency is doing its work properly.
In this paper, we shall discuss various functions of regulatory institutions both in the U.S and the U.K and also we shall be able to see their comparisons (Wiktorowicz, 2003). We shall also view critically how the drugs are controlled in these two countries. Since the implementation of the medicine Act in 1968, the U.K has had a huge number of drugs being withdrawn from the markets due to inconsistencies with the Act or some drugs were not up to the standards as stipulated by the medicine Act of 1968. But this influx of withdrawals cannot be compared to that of the united states since the Prescription Users Fee Act (PDUFA) was brought into operation in the year 1962. In this year (1962) the drug regulatory agency in the U.S was formed and it was called Food and Drug Administration (FDA). Finally, we shall be able to see the best protection system in the two countries.
Discussion
Control of Medicines in the U.K and the U.S
These countries have been crowned by the European drug regulations and the Europeanization of the drugs in the United Kingdom has played a big role in the regulation of drugs. The Europeanization of drugs in the U.K has led to the establishment of the European Medicines Evaluation Agency (E.M.E.A). This agency is mandated to control and regulate drug use across Europe and also offers significant assistance in America since some of the drugs used in the U.S are imported from European countries (Abraham and Lewis, 2000). The other institutions which help in regulating drugs in the U.K are as follows:
- British Pharmaceutical Industry(ABPI)
- Committee on Safety of Medicines(CSM)
- Department of Health’s Medicines Division(DoHMD)
- Medicines Control Agency(MCA)
In the U.K, several Acts of parliament embrace the medicine industry in self-regulation. The Acts of parliament and other regulating agencies come into place if the self-regulating process in the industry fails. The prescription and the medicine code of conduct and practice authority plays a very important role in the regulation of drugs in the U.K (Abraham and Lewis, 2000). The above-named agencies are also mandated to control the advertisements of medicines in the country. The agencies ensure that the information presented to the public is factual and accurate; furthermore, the information must be balanced.
The drug regulatory agency in the U.S, the FDA, collaborates with the manufactures to offer a transparent regulatory service; moreover, the FDA is also checked by the congress so as not to drift away from its activities.FDA has the capacity and authority to recall drugs that are in the market, impose banns on drugs that do not conform to the required standards and impose civil penalties on companies that neglect these rules. Drugs flow in the United States is also controlled by the government and other local authorities.
FDA is mandated to administer and promulgate all the medical devices rules and guidelines. Manufactures are given the option of involving third parties in the post-markets submissions of the appropriate medical devices. Before any medical product is launched in the market FDA must be informed in advance to issue an authorization report. Currently, the U.S uses very few third parties in the regulation process (Olson, 2002). Therefore, FDA is the sole government agency that controls and issues all the segments of pre-market authorization.
In controlling the drugs, the U.S government normally classifies the drugs in different classes according to dangers and risks they pose to the public and then assigns each class to a different regulatory agency. The U.S system of classifying drugs has three classes; the first class has the lowest risk to the public. This class is governed by general controls which ensure that class one devices are safe and effective (Wiktorowicz, 2003). These general controls prohibit, misbranding and adulteration, the general controls also apply to the other two sets of classification.
The next class of devices poses medium risks. In this case, the general control terms are insufficient in guarding these types of risks i.e. they may not provide adequate assurance of efficiency and safety. Social controls which are imposed in the class two devices include patient registries, post-market surveillance, performance standards, and recommendations.
The third class cannot be controlled by the general regulations because the risks are high. According to the U.S classification, class three devices are for sustaining and supporting human life, for example, the prosthetic heart valve. Such devices stay in this category until the Health and Human Services (HHS) ratifies the act or law.
Comparison of Regulatory institutions and agents in the U.K and the U.S
MHRA in the U.K employs a four-tiered system of classification which is based on the amount of risk the medical device poses to the public whereas in the U.S there is only three tiered classification system. The classification by MHRA does not only involve the risk but also incorporates the time a product is in direct contact with the human body and the degree to which the device invades the body. Unlike in the U.S market, manufactures of class one products in the U.K market do not necessarily need to inform the regulatory authority to conform to the marketing requirements, however, they must maintain documents for inspection in the future (Olson, 2002). Compared to the U.S, where a third party report must be presented to the FDA and hence making the final decision as regards the marketability of the device, no state agency reviews the decisions made by the notifying body, to conform to the U.K directive.
The U.K can restrict the entry of certain products which do not adhere to the directives; this is similar also to the U.S market. The MHRA can restrict the circulation of a product in the market, which may have entered the market without fulfilling requirements that are stipulated in the U.K government.
In both countries, there is the use of product surveillance after it enters the market. Pharmaceutical companies are required to inform ADRs of their drugs. Moreover, there is a system that was pioneered by the regulatory body in the U.K which collects ADRs reports which are voluntarily delivered by prescribing doctors: this system is known as the yellow card system. Thereafter the U.S also embraced this system of prescribing doctors in reporting ADRs to the regulatory agency.
In the staff selection of the U.K regulatory agency, the rules of conflict of interest are less strict compared to those in the U.S. To qualify as a staff in the FDA one must not be a manufacturer, installer, designer, and or consumer of the devices which are going to be inspected by the body. The members of staff must show competence, impartiality, and the ability to perform their duties without any imbalances (Abraham and Lewis, 2000). The agency rules also state that the salaries and allowances of the staff are not directly proportional to the amount of work they do or the number of inspections they perform. Other U.K conflict of interest regulations and rules are normally general and the person must comply with them.
Similarly, third parties and other personnel are not allowed to get involved with the other activities of the regulatory board in the U.S, either in the design, distribution, or manufacture of the products they are supposed to inspect. The U.K regulation is more moderate since it only prohibits the director and inspecting and assessment staff from such activities. Furthermore, the law does not prohibit consultative staff from offering their advice to designers and manufacturers.
The main difference between the two Countries have in their regulating bodies is that the U.K uses its regulating body to assess and verify processes and formalities, unlike the U.S which uses civil servants and government administrators to enforce the medical regulation procedures.
Regulatory systems in the U.S and the U.K that offers the best protection and advancement of public health
These two countries use the pre-market surveillance of the products rather than using the inefficient method of post-market surveillance which was being used by the FDA from the 1970s to 1990s. Many researchers and commentators view this system (pre-market surveillance) as fast and efficient in the protection of the public. The efficiency of this system is justified by the few numbers of withdrawals that have been made on products in the two markets i.e. U.K and U.S markets (Olson, 2002). The pre-market checks normally prevent the distribution and consumption of unsafe drugs. As compared to post-market checks the premarket system is faster and has a high quality of detecting ADRs.
Although the agencies try their best to protect the public from harmful drugs, not all the drugs can be detected before they enter the entire market and before they are licensed. This means that some risks are identified after the medicine is licensed because they emerge after the medicine or the drug has reached the wider population. To counter this problem, U.S and U.K agencies normally monitor reports of the drugs which are on the field or market using the Yellow Card scheme thus making the surveillance to be perfect. This type of regulatory system plays a big role in protecting the public from using low-quality drugs.
The other system which is used by U.S and U.K governments in regulating drugs and hence protecting the public is the use of clear and informative leaflets. This information is very vital for people who are on self-medication. The two governments are enforcing regulations to enhance clear labeling on the packets of drugs, this is important since many patients are understood to read the instructions (Wiktorowicz, 2003). With such information being availed to patients and the public, the governments of these two countries consider it as an efficient system of regulating drugs in the market.
Conclusion
In conclusion, medical regulating agencies should improve their methods of regulating drugs in the markets to adequately protect the public; otherwise, the public might end up losing confidence in them. Regulating agencies should also involve the public to assist in drug regulation (Abraham and Lewis, 2000). The public can offer reporting services in case a drug is suspected to have breached the requirements of the regulating board. By doing so, the withdrawal of harmful drugs from the markets could be made faster. For proper regulation of drugs, both governments need to increase the financial assistance to these regulating agencies. The agencies should not only blame the governments on their finances but should also manage what they have properly to avoid embezzlement of funds.
To increase surveillance on the drugs which are in the market, the regulating bodies should try the services of information technology which will hasten the process of data collection.
References
Abraham, J. (1995). Science, politics and the pharmaceutical industry: Controversy and bias in drug regulation. London/New York: UCL/St. Martins Press.
Abraham, J., & Lewis, G. (2000) Regulating medicines in Europe: Competition, expertise and public health. London: Routledge.
Olson, M. K. (2002) Pharmaceutical policy change and the safety of new drugs: Journal of Law and Economics, XLV, 615–642.
Wiktorowicz, M. E. (2003). Emergent patterns in the regulation of pharmaceuticals: Institutions and interests in the US, Canada, Britain, and France. Journal of Health Politics, Policy and Law, 28, 615–658.