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Pharmacopolitics, Implications and Implementation in Clinical Studies

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DOI: 10.18650/2378-5411.22003

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 Research Article www.enlivenarchive.org Enliven: Pharmacovigilance and Drug Safety
ISSN: 2378-5411

Pharmacopolitics, Implications and Implementation in Clinical Studies

Akshaya Srikanth Bhagavathula1, Asim Ahmad Elnour2*, Pinar Erkekoglu3, Alaa Mohammed Abdul Aziz4, Mirai Murad
Sadek5, Farah Hamad6, Abdulla Shehab7, Mohamed Baraka8, and Cristina Sanches-Giraud9
1
Pharm D, Department of Clinical Pharmacy, College of Medicine and Health Sciences, School of Pharmacy, University of Gondar-Gondar, Ethiopia
2
Associate Professor, PhD, Department of Pharmacology, College of Medicine and Health Sciences- UAE University, UAE
3
Associate Professor, Department of Toxicology, Faculty of Pharmacy, Hacettepe University, Sihhiye 06100, Ankara, Turkey
4
Pharm D student, Department of Pharmacology, College of Medicine and Health Sciences- UAE University
5
Pharmacist, MSc, Madinat Mohammed Bin Zayed Primary Health Care Center, Ambulatory Health Services, Abu Dhabi Health Services (SEHA), UAE
6
Associate Professor, PhD, Department of Pharmaceutics, College of Pharmacy- Ajman University of Sciences and Technology, Ajman-UAE
7
Consultant Cardiologist, PhD, Department of Internal Medicine, College of Medicine and Health Sciences- UAE University-UAE
8
Assistant Professor, PhD, Pharmacy Practice Department, College of Clinical Pharmacy, University of Dammam Eastern Province, KSA
9
Associate professor, Universidade Federal de São João del Rei, Divinópolis, MG, Brazil

Corresponding author: Asim Ahmed Elnour, Associate Professor,

*
Citation: Bhagavathula AS, Elnour AA, Erkekoglu P, Aziz AMA, Sadek
Department of Pharmacology, College of Medicine and Health Sciences, MM, et al. (2015) Pharmacopolitics, Implications and Implementation in
UAE, Tel: 00971506734096 E-mail: [email protected] Clinical Studies. Enliven: Pharmacovigil Drug Saf 2(2): 003.

Akshaya Srikanth Bhagavathula, Pharm D, Department of Clinical Copyright: @ 2015 Asim Ahmed Elnour. This is an Open Access article
Pharmacy, College of Medicine and Health Sciences, School of Pharmacy, published and distributed under the terms of the Creative Commons
University of Gondar-Gondar, Ethiopia, E-mail: [email protected] Attribution License, that permits unrestricted use, distribution and
reproduction in any medium, provided the original author and source are
Received Date: 28th April 2015
credited.
Accepted Date: 13th May 2015
Published Date: 18th May 2015

Keywords: Pharmacopolitics; Clinical trials; Pharmaceuticals Drug regulations

Definition of Pharmacopolitics

Prior to defining pharmacopolitics, one may wonder about this odd subject of basic drug sciences i.e. applied pharmacology, a plethora of
associations and relevancy of terminology. The word politics denotes pharmaceutical specialties has come forward such as pharmacokinetics,
articulating and resolving conflicts within society without recourse to pharmacotherapeutics, pharmacogenetics, pharmcogenomics, pharmac
physical violence [1]. Pharmaco stems from the Greek name Pharmakon/ oepidemiology, pharmacoinformatics, pharmacovigilance and pharmaco
Pharmacon which entail active ingredients/drug or medicine and is economics. Recently, a promising interest has been arising in the new sub
pertaining to pharmaceuticals and pharmacy sciences. Hence, the word specialty refer to as pharmacopolitics [2,3].
pharmacopolitics joined the politics to medicines-drugs-pharmaceuticals to
clarify the study of drug safety and efficacy (difficulties and solutions) in Pharmacopolitics is alarmed, with finding an appropriate equilibrium
relation to societal priorities, controversies, health budgets and associated between the risks and benefits of drug therapy (safety and cost-effectiveness)
costs. This juxtaposition of the two words emphasizes the significance and or risk-benefit ratio, with resolving the competing claims of profit for the
impact of pharmaceuticals on health decisions, health political conflicts and pharmaceutical industry and the broad public interest, and with decisive
societal health needs and priorities. pattern of how society should attempt to control the use of pharmaceuticals.

Background

The pharmacy profession sub specialties are emerging every decade with
an escalated velocity in last 20 years. Since the father of pharmacy the

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 The Current Status of Pharmacopolitics

The increase in populations around the globe leads to inadequate implication as they work to eliminate unnecessary delay in the global development and
of global politics, finance and administration. These-high profile disparities registration of new drugs.
also directly or indirectly affected the health care system such as inadequate
pharmaceutical costs, poor drug regulations, and shortage medical supplies. Since clinical trials now consume over half of drug companies’ RD spending,
For example, pharmaceutical firms in developed countries like United States manufacturers are highly motivated to cut down on the quantity and variety
of America (USA) and some European countries defend drug costs by of tests required by national regulatory agencies. The long-term goal of ICH,
explaining the expenditures during their clinical trials. On the other hand, however, is far more ambitious than to simply rationalize drug approvals and
due to these divergences many developing countries (unclear in many poor to create a world in which only one set of research trials is performed before
nations) fails to meet the health care needs, affordable to purchase the drugs, the global marketing of a new drug can take place [8]. In their vision of the
and these drug-politics were not even understood by common citizens [4]. future, data produced in this crucial experiment (or centrally coordinated
Global uniformity and standardization of the drug pricing, drug testing and set of clinical trials) will be reviewed using uniform standards. Recognizing
regulations is highly needed to the change in a variety of less visibly political the near-impossibility of dismantling well-established regulatory agencies,
settings. ICH hopes nonetheless that uniform product submissions will lead to the
same conclusions regarding a drug’s “approvability” around the world.
In recent years, there was huge number of consumers demanding the impact
of disease and appropriateness of competing treatments has broadened the Conclusions
attention in the medical politics and governmental health agencies. These
With the increased pharmaceutical costs and expensive developed new
perspectives also shed light on changing new arenas in drug policies. In this
therapeutic drug entities, a growing concern about developing a uniform
context, regulatory agencies has a key role to overseeing the pharmaceutical
standard of clinical trials, marketing and regulatory reviews is highly
industry in developing and maintaining the ways by demanding premarket
warranted. The science of pharmacopolitics will continue to delve deeper
testing and formal application for market approval [5]. New drugs achieve
the issues of public concerns. Pharmacopolitics research taking into
marketable status only if the manufacturer complies with government
consideration the consumers’ opinion and respective involved authorities.
guidelines for testing and provides authorities with evidence of their safety
and efficacy. These recent changes lead a massive research and development References
(RD) investments coupled with reaching the citizens expectations in fixing a
1. Heywood A (2002) Political theory: an introduction. Basingstoke:
wide variety of diseases, disorders, and discomforts.
Palgrave Press.

The International Perspectives 2. Daemmrich AA (2004) Pharmacopolitics: drug regulation in the United
States and Germany. Chapel Hill: University of North Carolina Press.
Over the past decade, multinational pharmaceutical companies have 3. Begg E, Sidwell A, Gardiner S, Nicholls G, Scott R (2003) The sorry
encouraged the mergers and greater cross-national RD investments. All saga of the statins in New Zealand: pharmacopolitics versus patient
these firms seek to market their medicines across the globe and work with care. J N Z Med Assoc 116: U360.
physicians in a variety of settings to meet regulatory demands. During 4. Abraham J, Reed T (2002) Progress, Innovation and Regulatory Science
Nineteenth century, the United States-Food and Drug Administration in Drug Development: The Politics of International Standard-Setting.
(US-FDA) has lead a new foundation in expanding its authority through a Social Stud Sci 32: 337-369.
sequence of legislative and regulatory initiatives, physicians authorities to 5. Andersson F (1992) The Drug Lag Issue: The Debate Seen from an
define drug safety and ability to control the use of pharmaceuticals. No one International Perspective. Int J Health Serv 22: 53-72.
group can easily claim a monopoly to represent patients in political settings 6. Rawlins MD (2013) Pharmaocopolitics: reflections on a subspecialty of
[6]. Pharmaceutical drug regulations in the USA thus are associated with clinical pharmacology. Eur J Clin Pharmacol. 69: 11-15.
significant renegotiation of authority among the key actors in medical policy. 7. Kurokawa T (2014) A historical review on International Conference
Thus, US-FDA plays a far greater role in all aspects of drug testing and on Harmonisation of Technical Requirments for Registration of
market surveillance. Pharmaceuticals for Human Use (ICH) and internationalization of
Japan’s new drug development and regulations. Fed Regist 49: 165-170.
Over the course of the last decade, European Federation of Pharmaceutical
8. Tominaga T, Ando Y, Kondo T (2012) International vision and strategy
Industries and Associations, FDA, Pharmaceutical Research and
for drug regulatory authority: the PMDA’s International vision. Clin
Manufacturers of America, Japan’s Ministry of Health, Labor and Welfare,
Pharmacol Ther 92: 349-351.
and Japan Pharmaceutical Manufacturers have worked closely to create
harmonized procedures for the global introduction of new drugs by a series of
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