Challenges of developing generics substitution policies in low- and middle-income countries (LMICs)

Submitted: 3 June 2015; Revised: 19 June 2015; Accepted: 24 June 2015; Published online first: 7 July 2015

Generics substitution is an act of switching from a brand innovator medicine to an equivalent, i.e. same active ingredient, dosage, form; generic drug product for the drug product prescribed [1–3]. Generics substitution can be implemented on either a voluntary or a mandatory basis. Generics substitution has been implemented in many European countries as part of demand-side policies to improve the utilization of generics [4]. In fact, mandatory generics substitution has resulted in medicine price reductions of 10–15% [4]. However, this is not a common scenario in low- and middle-income countries (LMICs).

Absence of a generics substitution policy in LMICs is a challenge to promoting the use of generics [5]. Some countries do not have a generics policy or have not positioned their generics policy as an integral part of their medicines policy [6]. Examples of such countries include Malaysia, Thailand and Vietnam [6, 7]. In addition, lack of clarity in legal regulations might prevent effective generics substitution [5]. For example, Malaysia had formulated a generics substitution policy as part of its National Medicines Policy in 2007. However, to date, there is still a lack of implementation and enforcement through legislation [8].

Another major challenge for substitution of generics in LMICs is the lack of evidence-based data/guidelines about bioequivalent or interchangeable medicines. Bioequivalence forms the basis of generics substitution [2]. In fact, concerns about bioequivalence and interchangeability of generics were the main factors affecting healthcare stakeholders’, i.e., physicians, pharmacists and patients, attitudes towards generics substitution [4]. Therefore, evidenced-based guidelines could be useful to assist healthcare professionals to appropriately perform generics substitution. Examples of such guidelines are the Orange Book in the US, the British National Formulary (BNF) in the UK, the Schedule of Pharmaceutical Benefits in Australia, and the list of interchangeable medicines in Finland and Sweden [7].

A functioning and reliable medicines regulatory authority is also important in ensuring the quality of generics [5]. Formulation or implementation of generics substitution policy in LMICs will be difficult unless stakeholders believe generic medicines are quality medicines [5]. Therefore, communication between medicines regulatory authorities in LMICs and healthcare professionals and medicine consumers is important to increase awareness of generics regulatory approval requirements and improve confidence in generics [7].

In addition, the characteristics of generics substitution policies can differ from country to country. In some countries, physicians may oppose, i.e. the level of justification for opposition varies across countries, and patients may refuse generics substitution or both scenarios may occur [4]. Therefore, adequate know ledge and positive perceptions among physicians and patients towards generics substitution is a prerequisite for developing effective generics substitution policies in LMICs. However, the literature shows that misconceptions still exist among these two important healthcare stakeholder groups [9, 10]. Therefore, educational interventions targeted to improve healthcare stakeholders’ knowledge about generics are needed.

In conclusion, the many challenges to developing effective generics substitution policies in LMICs include the absence of generics substitution policies, lack of enforcement, lack of evidence-based data about bioequivalence and lack of acceptance by physicians and patients. Adequate focus should be given to formulation/implementation of existing generics substitution policies in LMICs that includes the provision of adequate bioequivalence data that improves healthcare stakeholders’ confidence and acceptance of generics.

Competing interest: None.

Provenance and peer review: Not commissioned; internally peer reviewed.

Authors

Professor Mohamed Azmi Hassali, PhD
Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Minden, Penang, Malaysia

Zhi Yen Wong, BPharm (Hons), MSc (Pharmaceutical Policy), RPh Pharmacist/Researcher, Pharmacy Department, Hospital Teluk Intan, 36000 Jalan Changkat Jong, Teluk Intan, Perak, Malaysia

References
1. Hassali MA, et al. Generic substitution in Malaysia: recommendations from a systematic review. J Appl Pharm Sci. 2012;2(8):159-64.
2. Alrasheedy AA, et al. Is there a need for a formulary of clinically interchangeable medicines to guide generic substitution in Saudi Arabia? J Young Pharm. 2013;5(2):73-5.
3. World Medical Association. WMA statement on generic drug substitution [homepage on the Internet]. [cited 2015 Jun 19]. Available from: www.wma.net/en/30publications/10policies/20archives/d9/
4. Dylst P, Vulto A, Simoens S. Demand-side policies to encourage the use of generic medicines: an overview. Expert Rev Pharmacoecon Outcomes Res. 2013;13(1):59-72.
5. Kaplan WA, et al. Policies to promote use of generic medicines in low and middle income countries: a review of published literature, 2000–2010. Health Policy. 2012;106(3):211-24.
6. Nguyen TA, Hassali MA, McLachlan A. Generic medicines policies in the Asia Pacific region: ways forward. WHO South East Asia J Public Health. 2013;2(1):72-4.
7. Hassali MA, et al. The experiences of implementing generic medicine policy in eight countries: a review and recommendations for a successful promotion of generic medicine use. Saudi Pharm J. 2014;22(6):491-503.
8. Wong ZY, et al. Malaysian generic pharmaceutical industries: perspective from healthcare stakeholders. J Pharm Health Serv Res. 2014;5(4):193-203.
9. Alrasheedy AA, et al. Patient knowledge, perceptions, and acceptance of generic medicines: a comprehensive review of the current literature. Patient Intell. 2014;6:1-29.
10. Hassali MA, et al. Perspectives of physicians practicing in low and middle income countries towards generic medicines: a narrative review. Health Policy. 2014;117(3):297-310.

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