Jordanian stakeholder attitudes toward generic substitution

Abstract

About 10% of Jordan’s gross domestic product is spent on health care, almost one-third of which is spent on pharmaceuticals. Jordan’s pharmaceutical spending is a substantially higher percentage of gross domestic product than that of other developed countries. Generic substitution is a mechanism that could lower pharmaceutical spending costs in Jordan, but Jordan’s domestic law currently forbids pharmacists in the private market from dispensing generic equivalents to branded medicines without a physician’s approval. This article provides the results of a study that surveyed prominent organizational stakeholders (n = 17, RR 100%) in Jordan’s health care system and evaluates their opinions about generic substitution. The study finds there is a broad base of support for allowing and encouraging generic substitution in the private sector, and for mandating generic substitution in the public sector. Given that generic substitution may help to reduce health care costs and improve access to medicines, policymakers should consider legal and policy changes to facilitate generic substitution. The research suggests that key players in Jordan’s health care system will support such proposals.

Keywords

Generic substitution branded drugs branded generics health care policy access to medicines

Introduction

About 10% of Jordan’s gross domestic product (GDP) is spent on health care, and almost one-third of that is spent on pharmaceuticals.¹ In contrast, pharmaceutical spending as a percentage of overall health care spending in other developed countries generally ranges from 12% to 23%.¹ Jordanian pharmaceutical spending’s relatively high cost makes it a high priority for the Ministry of Health (MoH), particularly in light of limited resources and the government’s goal of providing universal access to health care.

Generic substitution is a mechanism that has been used successfully in other developed countries to lower the cost of pharmaceuticals. Generic substitution occurs when a pharmacist dispenses a generic drug in place of a brand name drug. Brand name medicines are pharmaceutical or biological drugs developed and marketed by originator pharmaceutical companies. Generic medicines are drugs with the same active ingredients as brand name drugs and with equivalent bioavailability within narrow margins. Generic drugs are typically available once the intellectual property protections affording to brand name drugs expire, and generic drugs tend to be less expensive than their brand name counterparts.² Although generic drugs are still relatively expensive in Jordan, the presence of generic drugs should lead to lower prices for consumers. However, Jordanian law forbids pharmacists from substituting a generic equivalent for a prescribed brand name medicine without a physician’s approval.³

Policies encouraging generic substitution may help to lower health care costs because, in the absence of such policies, health care providers, pharmacists, and patients may continue to utilize brand name drugs even when generic equivalents are available. This occurs for a variety of reasons. For example, some patients believe that generic drugs are inferior to their name brand equivalents. About one-third of patients express concerns after generic substitution, and some patients report reduced effects or new or increased side-effects.⁴ Furthermore, patients may object to generics because different manufacturers’ generics may bear no physical resemblance to one another or to their brand name counterparts.^5,6 Such packaging changes may be confusing to patients, and this may also impact medication adherence. In addition, for certain medications that have narrow therapeutic margins, generic substitution can cause adverse events. For instance, patients have reported seizures and other negative outcomes after generic substitution of certain anti-epileptic drugs.⁴

The prevalence of generic substitution is also impacted by financial incentives on health care providers, pharmacists, insurers, and patients. For example, patients with higher co-payment responsibilities tend to purchase more generics and are more likely to switch from branded to generic drugs when the relative savings are high.⁷ Or an insurance company might cover the full cost of a generic medicine, but only a portion of the cost of its brand name counterpart.⁸ As another example, physicians may preferentially utilize brand name medicines as a result of originator company promotion.⁴

Relatively little research has examined attitudes toward generic substitution despite the practice’s prevalence and importance.⁹ However, a couple of studies published in 2013 evaluated patient and pharmacist attitudes toward the subject in Jordan. One study sampled Jordanian patients (n = 500, RR = 80%) and found the high cost of medicines in Jordan is believed to be the primary impetus for choosing generic medicines.¹⁰ It also found that patients generally have positive attitudes toward generic medicines. Another study evaluated community pharmacists’ perceptions toward generic medicines and their opinions on future generic substitution policy implementation (n = 1252, RR = 58.8%).¹¹ The study found the majority of Jordanian pharmacists had a generally positive view of generic medicines, with more than 80% supporting generic substitution in most cases. The present study is the first to evaluate opinions regarding generic substitution among a broad base of stakeholders in Jordan.

Jordan’s health care system

Jordan is a small, lower-middle-income country in the Middle East. Its GDP is approximately 28 billion USD and 4615 USD per capita (2011).¹ About 10% of Jordan’s GDP is spent on health care. Almost one-third of Jordan’s GDP is spent on pharmaceuticals—$590 million USD in 2011, a high percentage in comparison to developed countries’ expenditures, which range from 12 to 23%.¹ In all, 72% of drug expenditures are in the private sector, versus 28% in the public sector.¹² Pharmaceutical drugs’ costliness helps explain why the pharmaceutical sector is a high priority for the Jordanian MoH.

Jordan’s health care strategy’s primary objective is to provide universal access to health care coverage. About 87% of Jordanians are estimated to be covered by some form of insurance and about 5–7% are covered by multiple insurances.¹ By his Majesty King Abdullah II’s royal decree, all children under six years of age have been insured since 2004. Jordan’s health care system is divided into two subsystems: the public health care system and the private health care system. The public sector includes the MoH (which includes tertiary hospitals, primary health care centers, and rural health posts), Royal Medical Services (RMS; the military sector), Jordan University Hospital (JUH), and King Abdullah University Hospital (KAUH). Jordan has implemented a network of public health care facilities, including 104 hospitals, 64 comprehensive health care centers, 377 primary health care centers, 238 secondary health care centers, 416 maternal child-health care centers, and 285 dental clinics.¹³

A low-paid government worker would generally need less than one day’s wages to purchase standard treatments in Jordanian public health facilities. Jordanian patients with public insurance normally receive their medicine from a government clinic or hospital. However, a patient will be referred to a community pharmacy if he or she gets a prescription from a government clinic or hospital, and the product is on the formulary but not in stock, and the clinic or hospital pharmacy stamps the prescription as approved but not available. The community pharmacy will get paid for the lowest priced available drug at the Jordan Food and Drug Administration (JFDA) rates. If a higher priced brand is dispensed, the patient will pay the difference. Patients without insurance normally approach a government institution first. They are required to pay a higher co-payment than insured patients, but, even so, this costs significantly less for uninsured patients than if they obtained medication directly through community pharmacies.

The private sector is the other major component of Jordan’s health care system. The private sector consists of approximately 9000 private clinics in Jordan and about 2090 independent community pharmacies, including 11 chain pharmacies (the largest chain pharmacy has 55 outlets distributed throughout Jordan), as well as hospital pharmacies located in 62 private hospitals (1031 physicians, 3435 beds).¹³ There are also several NGOs and donor-owned and operated facilities. The largest is the United Nations Relief Works Agency (UNRWA), which primarily provides health care to 1.66 million Palestinian refugees through 23 primary health care facilities. A total of 10% of Jordan’s hard currency is derived from medical tourism, so it is a priority to the government.¹⁴

In recent years, Jordan’s private health care system has experienced fundamental structural and financial changes. The most significant structural change was the dramatic increase in the number of people with private health insurance coverage. Today, about 7–8% of Jordan’s population has private health insurance coverage that is either self-funded or employer-purchased insurance. Third-party administrators (TPA) and pharmacy benefit managers (PBM) have recently emerged and changed the structure for health care financing. Today, there are 16 insurance companies that provide health coverage programs, five stand-alone TPA's, and one PBM.

Jordan’s pharmaceutical market

Almost 74% of the Jordan’s pharmaceutical supply is imported; the rest is locally manufactured. Jordan’s locally manufactured medicines are primarily generic medications sold under a trade name—branded generics. Nearly all generic medicines sold in Jordan, 97%, are branded generics.¹⁵ About 5% of local products are produced under a license with the originator brand’s manufacturer. Other local products are produced via contract manufacturing, where the originator company supplies the product in bulk to the local manufacturer and the product is re-labeled.¹⁴

The JFDA regulates the sale of medicines in Jordan according to the Pharmacy and Drug Law.³ Drug prices are strictly regulated in Jordan. Medicines must be registered for sale, and each medicine’s registration includes price setting. The MoH, RMS, JUH, and KAUH purchase medicines for the public sector with annual tenders issued under the medicines’ generic or scientific name or therapeutic group through a Joint Procurement Directorate which was established in 2007.¹⁶

Jordan’s pharmaceutical sector suffers from several problems documented in the National Drug Policy document approved by the Jordan Prime Ministry in 2002, which was revisited and amended in 2012.¹⁷ The most pressing problems include that (1) medicines are sub-optimally utilized, without careful management of limited resources; (2) spending on medicines is inadequate; (3) there is excessive public waste; and (4) there is poor availability of medicines in the public sector.

To maximize purchasing power, Jordan’s government should attempt to set the lowest possible price for quality generic pharmaceuticals. However, this is a politically challenging goal because of a strong domestic pharmaceutical lobby. Jordan’s pharmaceutical manufacturing industry consists of 20 companies that produce generics, which supply about 45% of the local market by volume and 25% by revenue.¹³ The majority of the medicines that those companies produce are exported (over 70%), and most of the markets that the medicines are exported to will not allow the companies to sell the medication at a higher price than the country of origin’s price. Thus, the industry’s incentive is to set high prices for domestically marketed medicine because higher prices will maximize the industry’s export revenue.

Pharmaceutical pricing

The Prime Ministry has approved pricing regulations for pharmaceutical companies to set prices for brand name drugs.¹⁸ A drug’s price is set at the lowest price established by one of four benchmarks: (1) the originator company’s suggested price, including customs duties, bank charges, insurance, clearing and inland transport costs, and drug store and pharmacy margins; (2) the originator drug’s selling price in its country of origin, after deducting value added tax (if applicable); (3) the originator drug’s average price as calculated by (a) averaging 16 reference countries’ public retail prices, or (b) averaging retail prices in fewer than the 16 reference countries when the originator drug is not available in all of the 16 reference countries (but more than 3 reference countries), or (c) a cost-effectiveness evaluation study when the originator drug is only available in fewer than 3 of the 16 reference countries; and (4) the originator drug’s export price to the Saudi market.

When Jordanian companies manufacture a generic drug, or when a generic drug is imported, the generic drug’s price should not exceed 80% of its originator brand’s registered price. Thus, the generic drug’s price is directly linked to its originator drug’s price. If an originator drug is re-priced, the generic drug’s price should not exceed 80% of the generic drug’s initial price or 80% of the originator drug’s new price, whichever is less.¹⁸

The supply chain for pharmaceuticals in Jordan is slightly different for imported pharmaceuticals and locally manufactured pharmaceuticals. For imported pharmaceuticals, local distributors receive the imports and then distribute the pharmaceuticals either directly to retailers or indirectly through sub-wholesalers or subagents. Consumers then purchase pharmaceuticals from retailers. For locally manufactured pharmaceuticals, the manufacturer can distribute the pharmaceuticals directly to retailers or indirectly to agents and wholesalers.

Each party in the supply chain increases the eventual cost of drugs for payers. The imported price to distributors is the export price to Jordan, which includes bank charges, custom duties, insurance, clearance, and transportation fees. Local distributors’ profit margins are fixed at 15%, plus 4% for administrative expenses, which is added to the imported price to form the pharmacy-selling price. Pharmacists then charge 26% on top of the pharmacy-selling price, comprised of 20% pharmacist’s profit and 6% expenses and fees. Finally, consumers pay an additional 4% value added tax (VAT). All pharmaceuticals in Jordan are subject to this pricing system, which incentivizes the sale of higher priced pharmaceuticals to maximize profits.

Pharmaceutical dispensing

In the public sector, MoH policy requires doctors in Government hospitals and health clinics to prescribe generic drugs when available. Under this system, if a brand name drug is prescribed, the patient is automatically dispensed a generic equivalent—a practice referred to as mandatory generic substitution. A patient may be dispensed a brand name drug instead of a generic equivalent if the prescribing physician receives special permission.

By contrast, in the private sector, pharmacists are legally prohibited from engaging in generic substitution without prescriber approval. Although private insurance companies encourage doctors to prescribe the lowest priced generic, doctors may not be provided with information about generics, and some doctors report that they prefer originator medicines even though they have confidence in locally produced generics. Pharmacists have a financial incentive to sell higher priced drugs, as their profit margin is a percentage of the drug’s price. If a brand name drug is not in stock, instead of attempting to prescribe a generic, a pharmacist may try to acquire the brand name drug for the patient from a neighboring pharmacy outlet. However, pharmacists wishing to prescribe generics can call physicians to receive approval for a substitute drug.

Generic and originator medicines

There are multiple definitions for generic medicines. A generic may be a drug that has the same active substance composition and the same pharmaceutical form as the reference medicinal product. The generic’s bioequivalence with the reference medicinal product must be demonstrated with bioavailability studies.⁵ A generic may also be a copy of an originator product with an expired patent.⁴ For example, when the originator’s patent for its active substance has expired.⁷ In addition, a generic may be identical, or bioequivalent, to a brand name drug in dosage, form, safety, strength, route of administration, quality, performance characteristics, and intended use. For quality assurance purposes, the Patent Law 21 of 2001 requires bioequivalence studies for generics at the time of registration.¹⁹

There are two ways to market generic pharmaceutical drugs. They can be marketed under a non-proprietary (rINN) name, which is the active compound’s generic name, or under a branded generic name. Manufacturers typically derive a generic drug’s branded name by combining the manufacturer’s name with the drug’s non-proprietary name. Manufacturers use branded generic names because they want to market the drug like a proprietary product.⁷ In Jordan, local pharmaceutical companies and generic importers have their own marketing teams and sales forces, but there are no official public education campaigns or strategies to promote generic medicines to patients, pharmacists, or prescribers. This lack of public outreach may lead to a poor perception of generics.

Developing a new brand name drug is an expensive undertaking.¹⁹ New drugs generally require time-consuming and resource-intensive clinical testing that establishes their safety and efficacy prior to market approval by a government regulatory agency.²⁰ Pharmaceutical Research and Manufacturers of America (PhRMA) claims that the cost of new drug development is approximately 1.2 billion dollars for each new drug.²¹ To incentivize this investment, new drug patents protect new drugs from generic competition for a period of time, generally 20 years from the date a patent application is filed.²² With a valid patent in force, originator pharmaceutical companies can exclude others from making, using, offering for sale, or importing the protected drug. Patents are especially important to the pharmaceutical industry because once a drug’s chemical composition is published others may be able to copy the product. A pharmaceutical drug’s manufacturing cost is typically only a small part of a drug’s selling price. A generic manufacturer does not have the same R&D costs that the originator drug’s manufacturer does, nor similar marketing costs.

In addition to patent protection, brand name medicines can also receive a period of market exclusivity as a result of registering a drug with the JFDA. The Unfair Competition and Trade Secrets Law 15 of 2000 protects pharmaceutical products by providing 5 years of data protection for data submitted for regulatory approval.²³ The protection begins on the date that the drug receives marketing approval and covers products registered by foreign companies after the law became enacted, regardless of whether the product is still on-patent.

However, a monopoly on a particular drug does not protect branded drugs from other forms of originator brand competition before the branded drug’s patent expires. For example, firms can discover and patent a number of different drugs that use the same basic mechanism to cure a disease.

Generic substitution

The WHO defines generic substitution as “the practice of substituting a product, whether marketed under a trade name or generic name, by an equivalent product, usually a cheaper one, containing the same active ingredient at the dispensing level.”¹⁶ By contrast, branded substitution occurs when a generic prescription is filled with a branded drug.⁸

In addition to switching a patient from a name brand drug to a generic drug, pharmacists sometimes engage in therapeutic substitution. Therapeutic substitution encompasses both switching within a drug class (i.e. the chemical entities are different, but the main therapeutic mechanism of action is the same) and switching between drug classes (i.e. the active chemical entities and mechanisms of action are different). Several professional bodies, including the American Medical Association, the American College of Cardiology, and the American Heart Association, oppose therapeutic substitution without the prescribing physician’s prior authorization.¹⁸

There are various generic substitution mechanisms. Pharmacists may be allowed, or even required, to substitute generics for brand name medicines, or they may be allowed to dispense a generic only if they first obtain authorization from a prescriber. Typically, physicians are given some control to prevent substitution in particular, qualifying situations.

Impact of generic substitution on health care costs

In most developed countries, drug costs have risen at a rate of approximately 10–12% annually.¹⁹ This inflation is partially due to increased drug use, as well as the introduction of new and more expensive drugs. Internationally, various pharmaceutical cost control mechanisms have been used to combat pharmaceutical cost inflation, including generic substitution.¹⁹ Generic use can be increased with mechanisms to incentivize generic substitution as well as pharmacy reimbursement incentives through regressive margins.⁷

Drug prices in Jordan have increased at a higher rate than most developed countries; prices have increased 20% between 2001 and 2007. Higher prices are threatening Jordan’s government public health programs’ financial sustainability. Furthermore, data suggest that generic competition has been delayed for 79% of medicines newly launched by 21 multinational pharmaceutical companies between 2002 and 2006. The additional cost to the consumer for medicines without generic competition was estimated at $18 million in 2004.²⁰

Both generics and originator brands can be excessively priced in Jordan. The HAI/WHO EMRO office’s Jordan medicine price and availability survey’s results suggest that the median retail price to patients for originator brands was about 17 times higher than the international reference price for the lowest priced generic drugs, the median price varied between 0.9 and 70 times the international reference price.²¹

After a patent expires, originator drug manufacturers do not necessarily lower the originator drug’s price to compete with generic drugs’ lower prices.^11,18,19 This may be because a branded drug has a base of consumer support, and those consumers are loyal to the originator brand and not cost-sensitive enough to switch to a generic.¹⁹ Patient demand for branded drugs while cheaper generic drugs are available may reinforce physician prescribing preferences for branded medicines.²⁰ Although residual physician and patient loyalty after a originator brand’s patent expires, this does not completely deter generic competition.^21,22 One study in Finland found that branded originator drugs’ prices declined by 4.5% after generics entered the market.⁹ So a higher penetration into the market by generic drugs may only result in modestly reduced originator drug prices.²³

The legal aspects of generic substitution in Jordan

In Jordan, the Pharmacy and Drug Law governs the sale of medicines. JFDA enforces the law.²⁴ At the end of 2008, the Higher Drug Committee decided to permit pharmacists to engage in generic substitution without consulting the prescriber as long as the substitution was for a drug with the same active ingredient, concentration, and dosage. The Board of Directors of the JFDA agreed to promulgate this decision in the formal Gazette. However, this initiative was halted because the Board decided not to proceed. The rational behind the decision to stop was that generic substitution would negatively affect local manufacturers’ domestic sales. Local manufacturers argued that they have spent a substantial amount of money marketing their products as branded generics. Accordingly, another meeting was arranged, and the decision was made to cancel the Committee’s publication. Thus, pharmacists are still not allowed to substitute generic medications without prescriber approval.²⁵

Generic substitution internationally

Worldwide, the use of generic medicines has grown.²⁶ It has been estimated that the use of generic medicines has reduced pharmaceutical spending costs in the US by $193 billion in 2011,²⁷ and over $30 billion in Europe.²⁸ European countries have adopted a variety of laws regarding generic substitution. Most EU countries encourage generic substitution with regulations, financial incentives, or a combination thereof. Only Italy and Portugal have adopted public advertising campaigns that promote generic drug use. Health care policies and market forces driving generic drugs in Europe are largely a result of each country’s laws as well as the originator drug manufacturer’s clout in each country.²⁹

The United States has responded to pharmaceuticals’ high costs by allowing each state to adopt its own generic substitution laws. “Positive Formulary” states have adopted a process that affirmatively identifies which generics can be substituted for name brand drugs. “Negative Formulary” states identify those drugs that cannot be substituted. Other states do not list which drugs can or cannot be used, but allow generic substitution so long as the drugs are pharmaceutically equivalent. The US FDA promulgated a non-binding publication called Approved Drug Products with Therapeutic Equivalence Evaluations that has guided these state policies.³⁰

Methods

A questionnaire was delivered to a sample of stakeholders in governmental institutions, semi-governmental institutions, non-governmental organizations, and private institutions. The goal was to evaluate their attitudes on generic substitution in Jordan’s public and private market. Seventeen stakeholders were selected for participation. There was a 100% response rate.

The questionnaire is attached in Appendix 1. It measures attitudes toward (1) allowing generic substitution; (2) encouraging generic substitution through physicians, pharmacists, and patients; and (3) mandating generic substitution. If survey participants supported encouraging generic substitution, they were asked to identify whether physicians, pharmacists, or patients were the key stakeholders to target to encourage generic substitution. Participants were also asked which of the following would be the most effective incentive to promote generic substitution: (1) increasing the profit margin for distributors; (2) increasing the profit margins for pharmacies; or (3) financially incentivizing physicians to prescribing generics. Finally, space was provided for open-ended comments.

The data collected from stakeholder surveys was coded and entered into the SPSS® database for statistical analysis then treated by simple frequency tables. Missing data were excluded from analysis.

Results

Figure 1 shows the overall attitudes of stakeholders toward generic substitution survey questions.

Figure 1.

Stakeholder responses to generic substitution survey. (a) Question #1; (b) Question #2; (c) Question #3; (d) Question #4; (e) Question #5.

Individual stakeholder attitudes are as follows:

Governmental institutions

Joint procurement department (JPD): generic substitution should be mandatory in both the public and private sectors. However, because such drastic reform is unlikely, JPD supports incremental changes. For example, by allowing generic substitution in the private sector, encouraging pharmacists to substitute by increasing their mark up for cheaper generic products, and rewarding physicians who prescribe generics. For the public sector, generic substitution should be mandatory through a tendering process.

High health council (HHC): supports encouraging generic substitution in the private sector and mandating it in the public sector. HHC also supports increasing pharmacists’ mark-up for cheaper medications to encourage generic substitution.

RMS: would allow and encourage generic substitution in the private sector by increasing mark-ups for both drug stores (agents) and pharmacies (retailers). RMS would mandate generic substitution in the public sector, and reward physicians who prescribe generically. For the public sector, RMS decision makers support mandating generic substitution in all tenders.

JFDA: would encourage and allow generic substitution in the private sector by increasing mark-ups for both agents and retailers. JFDA would also encourage and allow generic substitution in the public sector, but not for formulary listed patented medications.

MoH supply directorate: would mandate generic substitution in the public sector and encourage it in the private sector by targeting physicians and rewarding those who prescribe generically.

Semi-governmental institutions

King Hussein Cancer Center: would allow and encourage generic substitution in the private sector by targeting physicians, pharmacists, and patients. The Center would increase mark-ups for agents and reward physicians for prescribing generics. Regarding tenders, the Cancer Center would support mandating generic substitution.

King Abdullah University Hospital: would mandate generic substitution in the public sector and encourage generic substitution in the private sector by targeting patients and rewarding physicians who prescribe generically. It is a patient’s fundamental right to choose among alternative medications.

Jordan University Hospital: would allow and encourage generic substitution in both the private and public sectors. The Hospital recommends targeting pharmacists in order to encourage generic substitution and rewarding physicians for prescribing generics.

Non-governmental organizations

Jordan Pharmaceutical Association: would allow generic substitution in the public sector, and encourage generic substitution by targeting physicians and pharmacists. The Association would also increase mark-ups for agents.

National Association for Consumer Protection: would allow and encourage generic substitution in the private sector and mandate it in the public sector. The Association would encourage generic substitution by increasing mark-ups for retailers on cheaper medicines.

Pharmaceutical policy consultants (Dr Rania Bader and Dr Bader Rasheed) working in Jordan for some international bodies (e.g. USAID, WHO, MeTA, etc.): would allow, encourage, and mandate generic substitution in both the public and private sectors. Support targeting pharmacists and patients and increasing the agents’ mark-ups for cheaper generic products.

Private institutions

Jordanian Association of Pharmaceutical Manufacturers (JAPM) (local industry/branded generics): would allow, encourage, and mandate generic substitution in the public sector, but not in the private sector. However, the manufacturers support allowing generic substitution for only originator brands to any other generic or branded generic product but not substituting branded generics in any way to other branded generics or generics.

Originator brands importer agents association: recommends that generic substitution in the private sector should be left to the physician who has the right to decide whether the prescribed medication is allowed to be dispensed generically. The physician can do this by noting on the prescription that he or she approves generic substitution.

Generics importers agents group: would mandate generic substitution in both public and private sectors and encourage generic substitution in the private sector by targeting pharmacists and increasing the pharmacy mark-up for cheaper medications. The Importers Group would also encourage fast tracking generic registration and pricing.

Pharmacy outlets owners group (community pharmacies): would mandate generic substitution in the public sector and allow generic substitution in the private sector by targeting patients and pharmacists. The Owners Group would also increase the mark-up for pharmacies for selling cheaper medications.

Conclusion

There was some variation in stakeholder attitudes. All participants support allowing generic substitution in the private market, with the exception of importers of brand name medicines. There is also broad support for encouraging generic substitution in the private sector, including via financial incentives, and for mandating generic substitution in the public sector.

Given that generic substitution may help reduce health care costs and improve access to medicines, policymakers should consider legal and policy changes to facilitate generic substitution. The results of this research suggest there will be a base of support for such proposals among key players in Jordan’s health care system.

Footnotes

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Conflict of interest

None declared.

Author biographies

Ibrahim Alabbadi is a qualified pharmacist by profession since graduation in 1987 (King Saud University) experienced in pharmaceutical marketing with multinational as well as Jordanian companies in the Middle East. Dr Alabbadi got his MBA-Marketing (pharmaceutical pricing) in 2001 from the University of Jordan, completed his PhD in PharmacoEconomics from Queen's University, UK, in 2006; Dr Alabbadi is an Associate Professor in pharmaceutical marketing & PharmacoEconomics; has more than 19 publications (15 international), supervised more than 12 postgraduate students in applied research, worked as an Assistant Dean for training Affairs, Director of Scientific Research Documentation Office, Local Community Development & Networking Centre Director -- University of Jordan, Deputy General Director for Administrative Affairs – Jordan University Hospital, and currently Dean, Faculty of Pharmacy -- Yarmouk University -- Jordan; a newly established school focusing on industrial and pharmaceutical business. Dr Alabbadi was invited as a speaker and presenter in more than 65 scientific gatherings (41 international). Also an active member in many national and international health related committees e.g. JFDA, MoH, ISPOR, MeTA and HHC, etc. Furthermore, he is a reviewer for many international and local health related scientific journals, also an evaluator for some academic institutions' staff promotion. Dr Alabbadi is Jordan ISPOR chapter co-founder & current president and ISPOR Arabic Network cofounder and current executive committee chair.

Ryan Abbott, M.D., J.D., M.T.O.M., is Associate Professor of Law at Southwestern Law School and Visiting Assistant Professor of Medicine at the David Geffen School of Medicine at UCLA. He has served as a consultant on health care financing and regulation, intellectual property, and public health for international organizations, academic institutions and private enterprises including the World Health Organization and World Intellectual Property Organization. Professor Abbott has published widely on issues associated with health care law and intellectual property protection in legal, medical, and scientific peer-reviewed journals.

Professor Abbott is a licensed physician, attorney, and acupuncturist. He is a graduate of the University of California, San Diego School of Medicine and the Yale Law School, as well as a Summa Cum Laude graduate from Emperor's College (MTOM) and a Summa Cum Laude graduate from University of California, Los Angeles (BS). Professor Abbott has been the recipient of numerous research fellowships, scholarships and awards, and has served as Principal Investigator of biomedical research studies at University of California. He is a registered patent attorney with the U.S. Patent and Trademark Office and a member of the California and New York State Bars.

Deema Jaber is Clinical Pharmacist, American Pharmacotherapy Board, Biopharmaceutics and Clinical Pharmacy Department, College of Pharmacy, Jordan University.

Appendix 1

References

Jordan National Health Accounts 2010–2011: Jordanian Higher Health Council 2013: Technical report number 4. Higher Health Council, http://www.hhc.gov.jo/images/jordan/pdf/Jordan%20NHA%202010-2011.pdf (accessed 11 March 2014).

Kelly G. Improving the PPI sample for prescription pharmaceuticals. Monthly Lab Rev 1997; 10–17 Oct, http://www.bls.gov/mlr/1997/10/art2full.pdf (accessed 6 November 2014).

Pharmacy and Medicine Law, No. 12, 1 October 2013, Official Gazette No. 5344.

Decollogny

Eggli

Halfon

. Determinants of generic drug substitution in Switzerland. BMC Health Serv Res 2011; 11: 1–12.

Vivian

. Generic-substitution laws. US Pharm 2008; 33: 30–34.

Posner

Griffin

. Generic substitution. Br J Clin Pharmacol 2011; 72: 731–732.

King

Kanvos

. Encouraging the use of generic medicines: implications for transition economies. Croatian Med J 2002; 43: 462–469.

Pechlivanoglou

Van der Veen

Bos

. Analyzing generic and branded substitution patterns in the Netherlands using prescription data. BMC Health Serv Res 2011; 11: 1–9.

Timonen

Bengtröm

Karttunen

. The impact of generic substitution on the activities of pharmaceutical companies – a survey from the companies' perspective one year and five years after the introduction of generic substitution in finland. BMC Clin Pharmacol 2011; 10: 1–11.

10.

Faris El-Dahiyat Reem Kayyali . Evaluating patients’ perceptions regarding generic medicines in Jordan. J Pharmaceut Policy Pract 2013; 6: 3–3.

11.

Faris Abdelrahim El-Dahiyat Reem Kayyali . Community pharmacists’ perceptions towards generic medicines and their opinions on future generic substitution policy implementation: a descriptive study from Jordan. J Generic Med 2013; 10: 97–104.

12.

Jordan Ministry of Finance. General Expenditure Review, 2006–2007.

13.

Ministry of Health Annual Statistical Book 2012. Ministry of Health, http://www.moh.gov.jo/EN/Pages/Periodic-Newsletters.aspx (accessed 6 November 2014).

14.

The medical sector: related facts. private hosptials association, http://www.phajordan.org/EN/RelatedFacts/TheMedicalSector.aspx (accessed 6 November 2014).

15.

Drug Directorate. Jordan national drug formulary for essential drugs, 2nd ed. Jordan: Ministry of Health, 2002.

16.

Ryan Abbott and Ian Ayres. Evidence and extrapolation: mechanisms for regulating off-label use of drugs and diagnostics, 64 Duke L.J. 377.

17.

Jordanian Prime Ministry Decision Number 1759 in July 2006. [Arabic].

18.

Pharmaceutical Pricing Instructions, February 28, 2012, Official Gazette No. 5146.

19.

Taylor L. More funding necessary for EU generics review says industry. Pharma Times 2 February, 2009, http://www.pharmatimes.com/Article/09-02-02/More_funding_ necessary_for_EU_generics_review_says_industry.aspx.

20.

MDG Gap Task Force. Delivering on the global partnership for achieving the millenium development goals, http://www.haiweb.org/medicineprices/03092008/MDG8%20English%20Web.pdf (2008, accessed 6 November 2014).

21.

Johnston

Stafylas

Stergiou

. Effectiveness, safety and cost of drug substitution in hypertension. Br J Clin Pharmacol 2010; 70: 320–334.

22.

Jordan patent Law number 21 of 2001. Page 32. [Arabic].

23.

Birket

Mitchell

McManus

. A cost effectiveness approach to drug subsidy and pricing in Australia. Health Aff 2001; 20: 104–114.

24.

Ryan Abbott . Impact of strong intellectual property protection on access to medicines in Jordan. Medicines Transparency Alliance. J Generic Med 2012; 9: 75–75.

25.

Al-Abbadi

Qawwas

Jaafreh

. One-year assessment of joint procurement of pharmaceuticals in the public health sector in Jordan. Clin Ther 2009; 31: 1335–1343.

26.

Generic Pharmaceutical Association. Generic Drug Savings in the U.S. Fifth Annual Edition: 2013. http://www.gphaonline.org/media/cms/2013_Savings_Study_12.19.2013_FINAL.pdf.

27.

Ryan Abbott . Big data and pharmacovigilance: using healthcare information exchanges to revolutionize drug safety. Iowa L Rev 2013; 99: 225–225.

28.

Ryan Abbott. Documenting traditional medical knowledge. World Intellectual Property Organization, 2014.

29.

Sheppard A. Generic medicines: essential contributors to the long-term health of society. IMS Health, http://www.imshealth.com/imshealth/Global/Content/Document/Market_Measurement_TL/Generic_Medicines_GA.pdf (2009; accessed 6 November 2014).

30.

Article number 7 of Drug and Pharmacy Law: Medical records and prescriptions instructions (Nov 2008) approved by Higher Drug and Pharmacy Committee (not approved by the JFDA Board).