The shareholders’ perspective of the issue relative to
The drug manufacturing company
Malaria being a tropical disease mostly neglected by many pharmaceutical companies particularly in developed countries, the company’s innovation in designing a new cure for this disease will help to bridge the global health gap that exists between developed and developing countries. By investing less expensively in the research and development of the new drug, the company will also be able to develop effective and less expensive medication for many malaria patients worldwide (Oprea, Braunack-mayer and Gerickle, 2008, p.310)
The company’s shareholders
Drug research involves the identification and designing of new therapeutic agents while drug development entails the activities through which a new therapeutic agent is approved as being suitable for use as a medication. These two processes are very expensive for any pharmaceutical company wishing to develop a new drug because only a small percentage of all discovered drugs will end up being approved after investing heavily. According to Bain & company press release (2003), it is estimated that these costs can be as high as 1 billion USD considering that it takes a long time for revenue to be generated. Therefore, a company needs to consider these issues if the company expects to obtain reasonable revenue out of the huge investment.
The Food and Drug Administration
FDA’s regulations provide for the approval of drugs before they enter the market by undergoing pre-clinical and clinical trials. However, a company may obtain an exemption from these regulations through the investigational new drug (IND) application. Under this application, there are three IND types which include: an investigator IND/ research IND, emergency use IND, and the treatment IND. These types allow for the testing of unapproved therapeutic agents on human subjects. The emergency IND can also allow for studies to be conducted on patients relative to the provisions of 21 CFR, sec.312/ sec. 312.34 or when the patient or drug does not meet the prevailing testing protocols. On the other hand, the treatment of IND can be availed for a drug that is perceived to be portent against a life-threatening disease (U.S. Food and Administration, 2010). This company can apply any of the above is to be able to carry out tests for the new malaria cure on human beings.
Malaria Sufferers
As stated earlier, Malaria is a tropical neglected disease in most developing nations where it claims many lives, especially among children. Most of these deaths occur due to a lack of effective and affordable remedies or the existence of cases of health inequalities between the developing and the developed nations. The Discovery of this drug will thus prioritize Malaria to be a global research concern thereby eliminating the global health inequalities and social injustices that exist currently in the healthcare industry (Oprea et al., 2008).
The folks in the third world nations
Under the IND applications, the studies done on human subjects are regarded as interventions whereby the investigator administers specific procedures to the experimental subjects that will enable him/her to generate testable data which may also involve manipulation of the subjects’ environments. This can only be allowed if the minimal risk to the subjects is involved. Thus under this application, the investigator must submit these detailed procedures for qualifications. Additionally, informed consent of the subjects must be obtained before the investigation commences (U.S. Food and Drug Administration, 2010).
Recommendations to the Manufacturing Company’s Vice president
Many developing countries bear the burden of having to deal with a lack of effective and affordable medications for the numerous epidemics that face them. This then calls for the development and provision of effective and affordable medications. However, the subsequent testing of such drugs may raise several ethical issues. To explore these issues and consider them, several priority ethical issues have been identified to help many companies through these processes. These are community engagement, ancillary care obligations, resource sharing, care and treatment, and informed consents (Mamotte, Wassenaar, Koen and Essack, 2010, p.2). Under these issues, it is recommended that:
- The stakeholders should involve the community fully in the trial studies by imparting skills to the community members which enable them to participate in the exercise actively.
- The ancillary care procedure is developed and prioritized by partnering with local healthcare providers to ensure that referral services are provided for the experimental subjects.
- In case the subjects have been referred to local healthcare facilities, the researchers should make a follow-up for these persons to ensure that they obtain the required treatment.
- Informed consent from the participants should be formal and they should also be in a position to understand the concepts behind the tests to be conducted.
- Where such developments become successful, the resources should be shared equally across all the diseased entities.
Reference List
Bain & Company Press Release. (2003). Has the Pharmaceutical Blockbuster Model Gone Bust? Web.
Mamotte, N., Wassenaar, D., Koen, J., and Essack, Z. (2010). Convergent ethical issues in HIV/AIDS, tuberculosis and malaria trials in Africa: report from the WHO/ UNAIDS African AIDS Vaccine programme’s ethics, law and human rights collaborating centre consultation, 10-11 February 2009, Durban, South Africa. BMC Medical Ethics 2010; 11(3): 1-5.
Oprea, L., Braunack-Meyer, A., Gericke, C.A. (2008). Ethical issues in funding research and development of drugs for neglected tropical diseases. J Med Ethics; 35: 310-314.
U.S. Food and Drug Administration. (2010). Drugs: investigational new drug (IND) application. Web.