Research and development is a key stage in the process of developing drugs within the pharmaceutical industry. The processes commence when a candidate drug is identified and includes a number of rigorous tests that seek to determine the therapeutic suitability of the new drug. Key factors that research focuses on is the ability of the drug to interact with biological systems and its affinity to the targeted biological agents. Legal and policy provisions have made it possible to patent key discoveries made in the process of research and development. Patent protection has been seen as a tool for encouraging the private sector into investing more in the R"D process. Contract Research Organizations (CROs), and biotechnology companies have thus come up with regular budgetary allocations dedicated towards the research and development process. This paper discusses the process of research and development in the pharmaceutical industry. It focuses on various requirements of R"D ad how patent protection has affected the structure of the pharmaceutical industry. It also entails an examination on whether these requirements are among factors that affect firms in the process of developing and commercializing antiretroviral drugs meant for combating HIV/AIDS.
The Process of Research and Development in The Pharmaceutical Industry
Discovery and Development
Pharmaceutical R"D is defined as the scientific study of the certain disease mechanisms that lead to the discovery and development of agents that have therapeutic effect on humanity by impacting the disease mechanism under study. According to Rick (2009, p. 7) the initial process of pharmaceutical R"D can be divided into two broad phases: drug discovery and drug development. Drug discovery refers to the entire process of scientific exploration that results in discovering a clinical candidate. A clinical candidate is a biopharmaceutical substance or chemical that has an effect on a specified disease mechanism in animal disease and cellular models. The chemical composition and behaviour of the chemical substance should suggest therapeutic benefits to individuals who suffer from the disease. Many companies consider the process of discovery a running up to a point where there is proof of concept (Torjesen, 2015, n.p). Therefore, all the activities from lead optimization up to the proof of concept is considered as drug discovery. From this point, drug development will start with preclinical evaluation.
Drug development refers to all the scientific exploration of a clinical candidate with the aim of proving that it is safe for humans. The process of exploration also aims at establishing the efficacy of the drug and its therapeutic benefits to the target patients (Matraves 1999, p. 169). Drug discovery process is generally considered as less routine than development. One discovery can result in multiple developments where the entity concerned tests the viability of the drug in various backgrounds and forms.
Preclinical Research
According to the Medicines " Healthcare Products Regulatory Agency (2018, n.p), researchers must establish the potential of the drug to cause serious harm, or toxicity, before testing it on human beings. Medicines " Healthcare Products Regulatory Agency defines a number of product development regulations that underlie good laboratory practices. The organization involved in preclinical research must meet the minimum basic requirements for personnel, study conduct, equipment, operating procedures, written protocols and study reports (Scheel et al. 2013, n.p). Preclinical studies are usually not very rigorous. However, they must avail detailed information on toxicity levels and dosing of the drug. The results obtained at this level hep researchers determine whether the drug should be tested on human beings.
Clinical Research
Preclinical research mainly focuses on the drug’s safety However, the process does not substitute studies on interactions between the drug and the human body. Clinical research entails trials that are done directly on people. The developers design the clinical studies by considering what they want to achieve in the Investigational New Drug Process (IND) and Clinical Research phases. According to the Medicines " Healthcare Products Regulatory Agency (2018, n.p), the first phase should involve between 20 and 100 healthy participants and rake several months. The second phase involves several hundreds of people who are infected with the condition and should take up to two years. The third Phase involves between 300 and 3000 individuals with the condition and lasts between 1 and 4 years. The fourth phase involves several thousands of volunteers with the condition and has no defined time length.
Drug Review
After the three steps are successful, the developer presents their evidence to Medicines " Healthcare Products Regulatory Agency for review. The role of Medicines " Healthcare Products Regulatory Agency is to critically examine all the submitted data and arrive at a decision on whether to approve the new drug. The developer has the responsibility of submitting documents that tell the entire story on a drug for their own benefit. The report submitter should demonstrate that the drug is safe and effective for the intended use in the target population (Torjesen, 2015, n.p). The developers must also submit any relevant patent information, safety updates, proposed labelling, directions for use, information that shows that they have complied with institutional boards and any drug abuse information.
The review process is followed by approval if the drug is proven as being safe and effective. Medicines " Healthcare Products Regulatory Agency then works closely with the developer to address issues arising from the existing data. The agency may also ask for further research (Torjesen, 2015, n.p). The developer has the discretion on whether to continue with the researcher. There are mechanisms for lodging an appeal if there are disagreements between the developer and the agency.
If approved, the developed moves on with marketing plans. However, more discoveries and development are done when the drug is on the market. Reports of issues arising from prescription are regularly reviewed by the developer, Medicines " Healthcare Products Regulatory Agency, marketers and other relevant organizations (Svheel et al. 2013, n.p). In case problems or opportunities for improvement are discovered, relevant procedures should be followed to improve the drug.
How Requirements of R"D and Patent Protection Have Affected the Structure of the Pharmaceutical Industry
Pharmaceutical companies patent any discovery that shows promise in the development process. In the UK, patents prevent other companies from copying the discovery for 20 years. It covers several other aspects in its manufacturing, formulation and use in some instances. Patents enable the developer to recoup development costs and make a profit before the other entities can be let in to compete (Torjesen, 2015, n.p). Therefore, patenting provides an incentive to invest in the development of drugs.
Development of drugs involves many processes, that are often characterized by fails and repetition. If other entities are allowed to manufacture the drug in its early years and sell it alongside the developer, business entities will be less willing to invest in R"D. In The UK, one half of the patent period can expire before the developer finishes the required testing and obtains the necessary licencing. Therefore, most developers have about ten years to make profit and recover the development costs of drugs (Scheel et al. 2013, n.p). Generic versions of a drug can only be released after the patent on a drug has expired. In some instances, patent protection can be extended for further five and a half years. However, the extension should not take the patent to beyond 15 years since the drug received regulatory approval.
Medicines " Healthcare Products Regulatory Agency notes that regular revision of the requirements of R"D and patent protection are aimed at supporting innovation of in the pharmaceuticals industry. Despite these efforts, developers note that drugs and their development has become more expensive and complex (Matraves 1999, p. 171). The Medicines " Healthcare Products Regulatory Agency has a hard task of balancing between creating an enabling environment for developers and protecting consumers.
In response to the complex drug development process, developers have been soliciting information from regulatory agencies to avoid compliance issues. Communication channels have opened up between companies that invest in R"D and regulators to ensure that the companies compile relevant data before submissions (Scheel et al. 2013, n.p). The Medicines " Healthcare Products Regulatory Agency has set up a unique innovation office that provides support and advice to companies. The special office helps new developers to come up with unique products such as Nano-medicines, cell and gene therapy and treatments used in new delivery systems. The main Effect of strong patent protection is an increase in profits for the innovator for increased spending on R"D. HIV/AIDS is a unique condition that is spread across the world, unlike for other diseases whose breakouts are mainly localized. Therefore, innovation and general R"D spending is affected by global patent protection. Multinationals assess the global R"D and other factors associated with patent protection before investing in research and development.
Pharmaceutical innovation is financed from extra profits that the patent holders gain. Research into antiretroviral therapy is generally more expensive than other conditions caused by other microorganisms that are better understood by scientists. The UK has increased its support to developers. However, there is need for more support, especially in terms of public funding towards pharmaceutical innovation aimed at combating HIV/AIDS (Vasan et al. 2006, p. 395). HIV/AIDS is a major health concern in the UK and other countries around the world. Pressure has been directed towards individuals, business entities and government that have the capacity to help deal with the condition. However, pharmaceutical companies are profit-oriented and can only get involved in activities that foster the interests of the owners and sustainability of the company. Apart from meeting the expectations of stakeholders in the health sector, drug developers must also ensure that they are sustainable. Therefore, meeting the costs of R"D for HIV/AIDS antiretroviral therapy drugs will either require a long patent period or funding by government and private organizations.
Conclusion
R"D involves multiple processes that cost developers vast amounts of money. In order to encourage private entities to invest into the process, stakeholders in the health sector must ensure that private entities recoup the money invested in R"D. The demand for HIV/AIDS antiretroviral therapy drugs has been growing over the years. However, the R"D associated with these drugs is more rigorous and expensive because of limited discoveries on viral health conditions.
References
Matraves, C., 1999. Market structure, R"D and advertising in the pharmaceutical industry. The Journal of Industrial Economics, 47(2), pp.169-194.
Medicines and Healthcare Products Regulatory Agency. (2018). Annual Report and Accounts 2016/17. [Online] (updated 2018) Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/630517/MHRA_Annual_Report_and_Accounts_16-17.pdf [Accessed June 25, 2018].
Rick, N.G., Wiley-Blackwell, A. and von Arzneimitte ln, D.N., 2009. Drugs–From Discovery to Approval. [Online] (updated 2018) Available at: https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0031-1296420. [Accessed June 25, 2018].
Scheel, O., Wintermantel, T. and O’Keefe, J., 2013. Unleashing Pharma from the R"D value chain.
Torjesen, I., 2015. Drug development: the journey of a medicine from lab to shelf. Pharmaceutical Journal.
Vasan, A., Hoos, D., Mukherjee, J.S., Farmer, P.E., Rosenfield, A.G. and Perriëns, J.H., 2006. The pricing and procurement of antiretroviral drugs: an observational study of data from the Global Fund. Bulletin of the World Health Organization, 84, pp.393-398.
