Analysis of Ethical Issues, Regulations, and Globalization in Pharma

This report provides an in-depth analysis of ethical issues within the pharmaceutical industry. It explores the ethical dilemmas faced, focusing on animal testing, drug pricing, and the balance between innovation and ethical considerations. The report examines current regulations, including the Animal Welfare Act, and assesses their adequacy in addressing ethical concerns. It also discusses the challenges posed by globalization, such as varying international regulations and market dynamics. Furthermore, the report evaluates the effectiveness of self-regulation within the industry and identifies limitations. The report concludes with recommendations for future improvements, emphasizing the need for stricter regulations, ethical practices, and transparency to ensure patient safety and welfare. The report also emphasizes the importance of balancing the need for new medicines with ethical considerations such as animal welfare and drug pricing.

ETHICAL ISSUE IN
PHARMACEUTICS
INDUSTRY

Table of Contents
INTRODUCTION...........................................................................................................................1
MAIN BODY...................................................................................................................................1
1. Pharmaceutical Industry And Ethical Issues Faced By Them................................................1
2. Current Pharmaceutical Industry Regulations And Their Adequacy In Relation To The
Above Discussed Ethical Issue...................................................................................................2
3. Ethical dilemmas and need for change....................................................................................3
4. Challenges of globalization in pharmaceutical industry ........................................................3
5. Adequacy Of Pharmaceutical Industry Self-Regulations......................................................4
6. Limitation To Ethical Issues Within Pharmaceutical Industry And Recommendation For
Further.........................................................................................................................................5
CONCLUSION................................................................................................................................6
REFERENCES................................................................................................................................7

INTRODUCTION
Ethical issues can be described as a situation in which an organization need to choose
between what's correct and what's wrong. Ethics in Pharmaceutical industry is important as it
concerns with people lives. This study will focus on brief description of pharmaceutical industry
and ethical issues faced by them, current regulations in pharmaceutical industry, different ethical
dilemmas and what are the changes needed to overcome those dilemmas, different challenges of
globalization in pharmaceutical industry are explained, then adequacy of pharmaceutical industry
self-regulation and at last limitation to ethical issues in pharmaceutical industry and
recommendation in future have been explained.
MAIN BODY
1. Pharmaceutical Industry And Ethical Issues Faced By Them.
Pharmaceutical industry produces, develops, discovers, Pharmaceutical drugs or market
drugs that are used for medicines which are given to patients either to cure then or vaccinate
them. Many Pharmaceutical companies deal with any brand or generic medications or medical
devices. They need to follow variety of regulation and laws regarding safety, patenting,
efficiency, testing or marketing of drugs(Pearson and et.al., 2013). Pharmaceutical industry in
UK employees more than 70,000 employees while Pharmaceutical industry in whole European
union employees more than 700,00.
Ethics are the most important thing in business especially in Pharmaceutical industry as it
is concerned with medications. One of the major ethical issues faced by Pharmaceutical industry
is usage of animals for research and development. Almost one third of research is based on
animal research in UK. Animal based research is increasing continuously for development of
medicines used by humans or it can also be said that to bring advancement in medical treatments
like diabetes etc. In fact Pharmaceutical industry is using animals for biological studies as well.
Today animal usage in research and development has become a necessity for Pharmaceutical
industry for development, discovery and production of new medicines and treatment. However,
most of the companies are focusing on this ethical issue and reducing the use of animals in
research but has not completely eliminated it. Not only this nowadays if any new medicines are
developed they are first experimented on animals before testing on peoples(Sweet and Maxwell.,
2013). To reduce this animal usage an act has been passed in UK which states that until and
unless there is no other alternative and it is unavoidable and necessary, animal can be used only
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in experiments but they should be treated well, cared and trained properly. This act also says that
any alternative possible should be used whenever it is possible. Pharmaceutical industry in UK
focusses on innovation and development of new medicines for treatment of people which
includes few numbers of animals to be used only if necessary. Many Pharmaceutical companies
have accepted usage of animals but had tried to reduce it wherever possible(Adams., 2016).
2. Current Pharmaceutical Industry Regulations And Their Adequacy In Relation To The Above
Discussed Ethical Issue
There are many rules, regulations and laws that a pharmaceutical industry needs to follow
for research and development of medicines but very few of them are regarding usage of animals.
Due to many new emerging diseases, finding solutions for many unmet needs for many diseases'
usage of animals cannot be completely eliminated but there are some acts and regulations
because of which usage of animals has been reduced and are used only if necessary i.e. there is
no there alternative. For example testing vaccinations that are released in the market for people is
important to be tested so for this in many cases animals are used for it. But there are some acts
under which usage of animals have been reduced such as:
Animal welfare act minimizes usage of animals in research and development. This act
provides minimum protection to many species excluding mice and rats which are used in
research and development testing for new medicines. This act also excludes cold blooded
animals like fish, amphibians. This law sets some standards for these companies for feeding,
handling, housing, psychological well being of animals like chimpanzees. This act says that
until and unless there is no other alternative available animals can be used in research and
development testing for new medicines(Ferrell, Fraedrich and Ferrell,2017). There also an
institutional animal care committee which reviews all the facilities of animal, inspects animal
labs twice, reviews or approves or disapproves modifications required for research protocols,
reports deficiencies in animals and there use etc. but these acts and committees also have some
loopholes which leaves animals from protected to no protection as there rules and regulations are
so less that all these psychological and physical cruelty is continuously happening. All the
discomfort, pain caused to animals are strictly prohibited in Animal welfare act however if any
experiment is passed by institutional animal care committee then it cannot be changed only if
they state the scientific need of that particular experiment. So, regulations and laws regarding
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animal welfare and care need to be updated as it provided protection to animals but is not
sufficient for their protection and reduce their usage in laboratories.
3. Ethical dilemmas and need for change
In today's world any industry is expected to follow certain ethical practices for their
consumers benefits. Many people believe that consumers of any company should be their
greatest priority in manufacturing and developing a product. But many Pharmaceutical
companies faces a dilemma when it comes to give the best medicines to consumers but without
usage of animals as they need to test those products on animals before delivering it to people as
their safety is their first priority(Halbert and Ingulli., 2011). But for delivering those products
many animals are used, harmed and tested for new innovations in medicines as they cannot be
tested on humans. Many pharmaceutical companies compromise with their ethics to deliver
products to their customers and increase their profit margins. There are also many
pharmaceutical companies that faces the dilemma that weather they should only focus on
developing and producing new medicines for human use or they should focus on reducing usage
or testing of animals for developing new medicines.
There is need for change in pharmaceutical industry regarding this issue. For this
Utilitarian ethics theory can be applied which says that decisions should be based on what will
benefit best for majority. This theory only focuses on consequences of actions. For saving many
lives sanctification and compromises is needed to be done. In reality suffering of any individual
weather they are animals or human beings cannot be done(Kolah and et.al., 2013). In
pharmaceutical industry also usage of animals cannot be eliminated but should be reduced so that
it is favourable for both people and animals like before delivering any medicines it is needed to
be tested so only in this situation animals should be used so that medicines can be tested.
4. Challenges of globalization in pharmaceutical industry
Over last few years' globalization has been considered as one of the most important factor
for global economic activities. Pharmaceutical industry is one of those industries in which many
high income countries are ahead in both consumption and production. Pharmaceutical industry
has the highest Globalization rate then any other industry as most of the largest pharmaceutical
company's maximum sales is made outside their home country. Many pharmaceutical companies
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face challenges in collaborating with other countries pharmaceutical market as every country
has different sets of rules and regulations laws regarding this industry( Murray., 2014). So all
those pharmaceutical companies need to follow all those laws for their growth in that country.
But things are completely different in terms of European Union as all the countries in this union
has collaborated with each other in terms of drugs approval as they have a centralized system.
Pharmaceutical industry is growing very fast in European countries and UK as they have a
centralized system. If we see effect of globalisation in developing countries then their growth
rate in this sector can also improve if government increases their health care budget.
Globalization has increased chances for pharmaceutical companies to grow and expand their
business and also helped them to change their structure and increase competition in global
market. Globalization has helped many multinational pharmaceutical companies to develop
strong market position globally with high market shares and has affected global economy. But on
the other hand globalisation has also affected this industry negatively as nowadays to increase
their revenue and gain profit many pharmaceutical companies has started to compromise with the
quality, increased cost price of their drugs i.e. they have started to compromise with their ethics
and only concentrates on profit(Velasquez., 2012,). This has also created an affordability issues
for middle class people.
5. Adequacy Of Pharmaceutical Industry Self-Regulations
For adequacy of Pharmaceutical industry self-regulation stricter laws should be
implemented. Pharmaceutical companies may also need to take printed and electronic copies of
all the rules, regulations and laws which are needed to be maintained in the practice settings as it
is important in inspections. Code of practice in this industry is important as the purpose of this
code is ensuring relationship between health care professionals, companies to minimize conflicts
of interest.
There are many legislations that take place in UK and Europe which ensures the
efficiency and safety of a new medicine that weather it is safe of use(Palgrave., 2012). Many
professionals keep a track on any changes made in legislation for ensuring that proper clinical
traits have been performed before submission of any application after ensuring safety, efficiency
and quality of medicines EU and UK legislation continuously monitors the medicine.
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Need of licensing and developing is important for its efficiency and to bring scientific
changes to fulfil patients demand. For this regulatory innovation is important. In this according
to the generated data medicine is licensed in a group of targeted patients. Licensing is important
for development of medicine more efficient and to increase patients' access to medicine where
there is much need of that medicine. For success of any medicine all the stakeholders should be
involved equally in this. UK agency is responsible for innovative approaches and good practices
for discipline. They are responsible of maintaining all the policies, regularities, and legislative
departments. Pharmaceutical industry operates independently but with rules, regulations, laws
and legislation of Government. Further safety and regulations of any medicine and medical
devices is ensured by UK agency MHRA i.e. Medicines and Healthcare products regulatory
agency if united kingdom by sending news, publications, information and warnings. There is also
an European medical agency (EMEA) which is basically a decentralized body headquartered in
London of European union. This agency also prescribe guideline for general reporting and
inspection of all aspects of veterinary and human medicines in whole European union. For
development and registering of all the new medicines proper guidelines are defined for
efficiency, safety and quality related all the aspects are passed by IHC i.e. International
conference on harmonization of technical requirements for registration of Pharmaceutical for
human usage.
6. Limitation To Ethical Issues Within Pharmaceutical Industry And Recommendation For
Further
There are many limitations to ethical issues within a pharmaceutical industry such as:
First and the foremost is pricing of medications. Many pharmaceutical companies increase prices
of there medicines to increase there revenue and profit which becomes less affordable of public
to buy those medicines. Many medicines made are intentionally prescribed to patients for
benefit of doctor as well as pharmaceutical company. Another unethical practice which is done
by many pharmaceutical companies is usage of animals in development and testing of medicines.
Most of these companies use many animals for there testing of medicines weather they are safe
of human use. Another unethical practice done by these companies is that they do not make the
medicine easily available so that demand of those medicines are high and they need not to
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provide any discounts on those medicines and they can sell those medicines at the same rate to
increase their profit(Wiley and Dowson., 2012).
Recommendation: Pharmaceutical policies must be renewed which should ensure that
new medicines made are easily available to patients at an affordable price. As these companies
easily manipulate these patient policies so these policies should be updated in such a way that
they determine availability and affordability of medicines for people. These policies should
ensure that research and development of new medicines are done in such a way that it does not
increase the current price of medicine though they work in private sector but they provide service
in public sector. A centralized department should be set up which can ensure the quality and
safety of medicine as many pharmaceutical companies degrade the quality of medicine to
increase there profit margins.
CONCLUSION
From the above study it has been summarized that there are many ethical issues in
pharmaceutical industry but most major issue is use of animals in for development and testing of
medicines. Many companies use animals excessively without thinking about their safety. There
are many agencies which sees the welfare of these animals to overcome those issues but with
limitations. There are many ethical dilemmas faced by this industry and there is a need for
change in this industry. There are also many challenges of globalization in this industry, few of
them are favourable and profitable of those companies and few of them are not. There are many
regulations and laws which regulates this industry, all those had been explained the above
document and at last many limitations to ethical issues within pharmaceutical industry and there
are many recommendation given for improvement in this industry.
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REFERENCES
Books and journals:
Pearson Smith and et.al., 2013, Glanville Williams: Learning the Law (15th Edition).
Sweet & Maxwell McLeod, I. 2013, Legal Method (9th Edition).
Adams, A. 2016,Law for Business Students, 9th Edition, Pearson Publishers.
Ferrell, O.C, Fraedrich and Ferrell, L. 2017,Business Ethics: Ethical Decision Making & Cases,
(11th Edition). Cengage Learning Jonathan Herring ,2017, "Business ethics" in Legal
Ethics Law
Halbert,T. and Ingulli E. 2011, Law & Ethics in the Business Environment. (9th Edition).
Cengage Learning.
Kolah and et.al., 2013, Essential Law for Marketers, 2nd Edition, Butterworth Heinemann
Recommended resources: Marianne Jennings Business Ethics Case Studies and Selected
Readings (9th Edition) Cengage Learning
M and Murray, A. 2014, Corporate Responsibility a critical introduction. Oxford University
Press.
Velasquez and M. G., 2012, Business Ethics Concepts & Cases (7th Edition). Pearson. Morrison,
J. (2015) Business ethics: new challenges in a globalized world. Basingstoke:
Palgrave Macmillan Cannon, T. 2012, Corporate Responsibility Governance, compliance and
ethics in a sustainable environment (2nd Edition).
Wiley and Son Robinson, S. and Dowson, P. 2012, Business Ethics in Practice. Chartered
Institute of Personnel and Development.
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