
LEARNING OUTCOMES
By the end of
this lecture students should be able to:
Discuss the
access to essential medicines.
Demonstrate an
understanding of the effects of global pharmaceutical practices on the
availability of antiretroviral medications in sub-Saharan African countries.
Recognize the
marketing practices employed by pharmaceutical companies when dealing with
medical graduates and students.
Have an introductory understanding of clinical drug trial and publication practices.
RESOURCES
• Ministry of Health. Medicine price monitoring in Malaysia 2017 (EXECUTIVE SUMMARY ONLY)
• Ofori-Asenso R, Agyeman A. Irrational use of medicines—A summary of key concepts. Pharmacy. 2016;4(4):35. PubMed PMID: doi:10.3390/pharmacy4040035.
• Austad KE, Avorn J, Kesselheim AS. Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic review. PLoS Med. 2011 May;8(5):e1001037. PubMed PMID: 21629685. Pubmed Central PMCID: PMC3101205. Epub 2011/06/02. eng.
ACCESS TO MEDICINES: A CRITICAL AND GROWING PROBLEM
A little over two billion
people lack access to essential medicines. As this gap
continues to widen, it contributes to ongoing illness and avoidable disability
and deaths1, highlighting another critical dimension of health
inequity. In this regard, it is reported that the average availability of
generic medicines is only 38 percent in the public sector in low-and-middle-income
countries (LMICs) and medicines in the private sector are unaffordable2.
This poses a considerable challenge as expenditure on medicines constitutes 25%
to 65% of total public and private spending on health and 60% to 90% of
household expenditure on health in developing countries2. In this
regard, access to medicines is especially problematic for rare diseases3
and neglected tropical diseases (NTDs)4 for which there is a paucity
in the research and development of drugs.
In improving access to medicines, essential
medicines play an important role. Essential medicines are those that satisfy
the priority health care needs of the population. They have public health
relevance and have evidence on being effective, providing clear clinical
benefits, and being affordable1.
The World Health Organization states that ‘essential medicines are
intended to be available within the context of functioning health systems at
all times in adequate amounts, in the appropriate dosage forms, with assured
quality and adequate information, and at a price the individual and the
community can afford5.
Factors contributing to poor access to medicines include inefficient procurement processes and practices, tax and tariff policies, and mark-ups along the supply chain which increase drug prices and make them unaffordable1. Additionally, access to medicines also depends on the strength and efficiency of national drug regulatory authorities1. Further, international trade agreements and intellectual property rights regimes have also been cited as a threat to equitable access to medicines6. Finally, corporate practices of big pharma, including irregular marketing practices, excessive expenditure on marketing vis-à-vis research and development, have also been cited as factors contributing to asymmetries in the sector and access to medicines.
In recent years, there has been concern about the exposure of medical students to pharmaceutical companies. The concern is for the consequences it has for the development of their medical identity and medical mores as a result of pharmaceutical gift-giving and reciprocal obligations7,8.
This has led to calls to include education on the pharmaceutical industry’s marketing and product promotion practices on clinician prescribing.
All these issues assume greater
significance as COVID-19 creates an urgency to expand access to medicines,
including addressing affordability and fair pricing, strengthening national
financing mechanisms to promote long-term and sustainable funding, and
leveraging broader partnerships9.
REFERENCES
1. World Health Organization. Ten Years in Public Health, 2007-2017—Report by Dr Margaret
Chan, Director-General—Access to medicines: making market forces serve the poor
[online] Geneva2017 [Accessed: 20 May 2021]. Available from:
https://www.who.int/publications/10-year-review/chapter-medicines.pdf.
2. Leisinger KM, Garabedian LF, Wagner AK. Improving access to medicines in low and
middle income countries: corporate responsibilities in context. Southern med review.
2012;5(2):3-8.
3. Dharssi S, Wong-Rieger D, Harold M, Terry S. Review of 11 national policies for rare
diseases in the context of key patient needs. Orphanet Journal of Rare Diseases.
2017;12(1):63.
4. Holt F, Gillam SJ, Ngondi JM. Improving access to medicines for neglected tropical
diseases in developing countries: Lessons from three emerging economies. PLOS
Neglected Tropical Diseases. 2012;6(2):e1390.
5. World Health Organization. Essential medicines [online]: WHO; [Accessed: 15 May 2021].
Available from: https://www.who.int/topics/essential_medicines/en/.
6. Subhan J. Scrutinized: the TRIPS agreement and public health. Mcgill J Med.
2006;9(2):152-9.7. Austad KE, Avorn J, Kesselheim AS. Medical students' exposure to
and attitudes about the pharmaceutical industry: a systematic review. PLoS Med. 2011
May;8(5):e100103
7. PubMed PMID: 21629685. Pubmed Central PMCID: PMC3101205. Epub 2011/06/02. eng.
8. Rogers WA, Mansfield PR, Braunack-Mayer AJ, Jureidini JN. The ethics of pharmaceutical
industry relationships with medical students. The Medical journal of Australia.
2004;180(8):411-4.
9. Minghui R, Simao M, Mikkelsen B, Kestel D, Ball A, Szilagyi Z. Gaps in access to essential
medicines and health products for noncommunicable diseases and mental health
conditions. Bull World Health Organ. 2020;98(9):582-a.
Let’s start by getting an overview of the pharmaceutical industry.
Before we look at some of the problems in the pharmaceutical industry
let us review the guidance from the World Health Organization on access to
essential medicines
With the understanding of essential medicines which satisfy the priority health care needs, let us look at some of the questionable marketing practices of the pharmaceutical industry.
In this section, we take a look at the World Trade Organization and TRIPS and see how they are related to the issue of access to medicines.
Let us now briefly look at clinical trials in discussing the pharmaceutical industry.
Finally, we try to get a glimpse of some issues related to access to medicines in Malaysia.