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The Portuguese generic medicines market: What’s next?
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The Portuguese generic medicines market: What’s next? Alexandre Morais Nunes a,b , Diogo Cunha Ferreira b,∗ , Andreia de Matos a , Rui Miranda Julião a a b
CAPP, Instituto Superior de Ciências Sociais e Políticas, University of Lisbon, R. Almerindo Lessa, 1300-663 Lisbon, Portugal CERIS, Instituto Superior Técnico, University of Lisbon, Av. Rovisco Pais, 1049-001 Lisbon, Portugal
a r t i c l e
i n f o
Article history: Received 20 June 2019 Received in revised form 11 January 2020 Accepted 24 February 2020 Keywords: Generics Portugal Economic crisis Broadening use of generics
a b s t r a c t Brand-name medicines have dominated the Portuguese market for several decades with unquestionable exclusivity. This resulted particularly from the absence of a requirement of prescriptions by international non-proprietary name. To promote the enhancement of both efficiency and sustainability in the health system, the Portuguese government introduced the generics in Portugal by the 90 s. However, only in the first decade of the 21st century were some policies implemented to increase their market share. Although some expectations were created, the use of generics has increased moderately during that period, in which policies to promote them were consolidated by imposing the austerity principles in the midst of the economic and social crisis. This study analyses the main policy measures already implemented as well as the incentives created for the replacement of brand-name medicines with generics. In addition, the present study also makes some recommendations to promote a broader and better use of generics in Portugal. © 2020 Elsevier B.V. All rights reserved.
1. Introduction Over the past few decades and even with some implemented policy and regulatory measures, brand-name medicines have dominated the Portuguese pharmaceutical market almost exclusively. Generic medicines (or simply generics) were insignificant in this market until a few years ago. Nevertheless, the use of generics has been recognized in the literature for their safety, quality, and efficacy, which are as high as brand-name medicines [1,2]. Also, promoting the consumption of generics contributes to the rational use of medicines and generates cost savings for both users and health systems [3,4], including those based on a National Health Service (NHS), funded from a general state budget. Portugal and the UK are two examples of countries following this health system organization. Although some measures promoting the commercialization of generics have been endorsed since the beginning of the 21st century, Portugal has still a volume-based market share of generics of nearly 48.4 % in 2018, which compares to 31.4 % in 2010 and 41.4 % in 2015. Note that the Portuguese pharmaceutical market in 2018
∗ Corresponding author. E-mail addresses: [email protected] (A.M. Nunes), [email protected] (D.C. Ferreira), [email protected] (A. de Matos), [email protected] (R.M. Julião).
was D 2460 million or 220 million units sold. Even with a considerable market share growth in the past few years, Portugal is still far from other European countries, like Germany (80–81 %), UK (83–84 %), and Netherlands (70–71 %) – data from 2013 and 2014 [33,5]). The lack of prescription of this type of medicines by physicians and the distrust of users regarding its efficacy and safety help to justify such a low market share in Portugal [6]. The measures employed to promote generics in Portugal were consolidated by imposition of the Memorandum of Understanding applied in Portugal by 2011. In fact, this year external assistance was requested from the International Monetary Fund, the European Central Bank, and the European Commission, composing the triumvirate commonly known as Troika [7]. By this time, Portugal was facing a period of economic and social crisis that resulted from serious financial problems. As a result of the increase in public spending, those problems led to a fall in Gross Domestic Product (GDP) by 4.4 % (the average of the 28 EU countries grew by 2.9 % in the same period). This has hampered the credibility of Portugal within international markets, with the consequent worsening of sovereign debt interest rates, which have reached unacceptable levels [8]. Based on this panorama and financing problems, Troika concluded that the best way to overcome the crisis would be through a policy based on strong austerity measures aimed at reducing excessive and inefficient spending [9]. In the implementation of
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this objective, a reform was carried out based on cuts in spending and the promotion of greater efficiency [9,10]. In the years leading up to the financial crisis, and according to OECD data, pharmaceutical spending was one of the highest spending on health, under a continuous growth. In 2004, those expenses amounted to D 3163 million (21.1 % of the current spending with health), which grew by nearly 8% until 2010 to D 3404 million (18.1 %). In terms of spending per capita, those figures result into D 446 in 2004 and D 518 in 2010 (+16 %). Furthermore, expenditure on medicines accounted for 17.7 % of total expenditures with health in Portugal, from which 55.9 % were borne by the State. Given these high costs due to the pharmaceutical sector and the Troika request to reduce public health expenditure, this was a target area to promote efficiency gains (Ginsburg, 2014). In the Portuguese case, they would result from reducing the high costs often associated with corruption, inefficiency, and the policy related to the pharmaceutical market – including the slow pace of generics entry into the pharmaceutical market, no mandatory electronic prescription, and the lack of generalization of the International non-proprietary name (INN) prescription [11]. To increase the use of generic medicines in Portugal, successive governments have implemented several policies in the past few years, including (1) the mandatory requirement for INN prescription, (2) the adjustment of the price of the generic medicine marketed, at the most, by half of the price of the brand-name medicine with the same active ingredient, and (3) the improvement of the substitution process, making it easier. Such policies were expected to substantially increase the share of generics in the austerity period up to 60 % in terms of ambulatory market volume, which was clearly an ambitious goal given the market share of these medicines in Portugal prior the crisis period. In addition to the promotion of generic medicines selling, the Memorandum of Understanding signed between the Portuguese Government and the Troika provided for further medicines policy, namely the introduction of innovative medicines, the re-definition of prices, the reimbursement of pharmaceutical products, the monitoring of prescriptions, the fight against corruption, and the implementation of new legislation for pharmacies. Although there exist several measures underway in the Portuguese pharmaceutical sector, the present study concentrates on the ones promoting the generics’ market share increasing, since it is a transversal measure started at the end of the 20th century, with sufficient time for consolidation. This article analyses the main policy measures implemented as well as the incentives created to replace brand-name medicines by generic medicines. In addition, and in line with those measures, we make some recommendations to indorse a broader and better use of generic medicines in Portugal. The paper is structured as follows. Section 2 reviews the generic medicines’ prescription measures implemented in the past (until 2011). Section 3 presents the medicines-related policies executed during and after the austerity period (2011-onwards). Section 4 presents and discusses the main results attained by policies trying to raise the market share of generic medicines in Portugal. Section 5 identifies some recommendations for future policies in the sector. Finally, section 6 concludes the study.
2. The generic medicines market in Portugal before 2011 The introduction of generics in the Portuguese market resulted from the Medicines Statute of 1990. This law regulates the life cycle of all medicines in Portugal, ergo characterizing the generic medicine, presenting its benefits to the user and establishing that the prescription should be restricted to the generic name or to the INN of the active ingredients. With the amendment to that statute in 1998, it is now required to indicate the dosage form in
generic medicines. Since the end of the 90 s, several actions have been undertaken to put generics forward, raising their consumption. These actions can be clustered in terms of: (1) prescriptions and out-of-pocket payments; (2) definition of prices; (3) mitigation of barriers to the entry of generic medicines; and (4) creation of incentives to the prescription of these medicines. 2.1. Prescriptions and out-of-pocket payments In the first decade of the 21st century, several rationalization policies were implemented in the prescription of medicines, e.g. the monitoring of INN prescriptions, and the improvement of the citizens literacy regarding the existence of generics as an additional option, when the prescriber physician does not opt by a specific brand-name (Law no. 14/2000, of August 8). In 2002, due to non-compliance of physicians with the prescription regulation, it was necessary to induce the (mandatory) requirement for INN prescriptions. However, reference to the brand-name was still allowed. Therefore, it became compulsory to inform the user about the existence of a biosimilar generic medicine as well as its lower price compared to the brand-name medicine (Decree-Law no. 271/2002, of 2 December). In 2010, the reimbursement rules related to medicines selling were changed. Since then, the State reimburses electronic prescription, in a strategy to reduce public spending through the association between INN prescription and consumption of generics. 2.2. On defining the prices for generics In 2000, the Portuguese government defined the State’s share of the medicines price. This year, the 10 % mark-up was introduced for all generics. That amount would increase to 15 % for the cases of lower household income (Decree-Law no. 205/2000, of 01 September). In 2001, a special price regime for generic medicines was established: the price of a generic medicine could not be larger than 65 % of the price associated with the brand-name medicine with equal dosage and in the same dosage form (Ordinance no. 577/2001, of June 7). In 2002, the policy of the medicinal product concerned the reference price system introduction and application to the medicines belonging to the same homogeneous group, i.e., those with the same qualitative and quantitative composition as active substance, dosage form, dosage and route of administration including at least one generic medicine with market authorization. The reference price is calculated based on the most expensive generic of its own group (Decree-Law no. 270/2002, of 2 December). Later, in 2008, the Decree-Law no. 1184/2008 and the Ordinance No. 1016-A/2008, of September 8, sought to gradually reduce the maximum sale prices associated with medicines. Accordingly, it should be possible to reduce the retail price of generics by 30 %. Exceptions include the generic medicines sold by less than D 5 as well as the cases in which the reduction would result into a selling price of less than half of the reference (brand-name) product. This measure has, however, been revised over the years (up to 2011) in order to continue the attempt of reducing prices (Ordinances 1551/2008, of December 31; 668/2009, of June 19; 1047/2009, of September 15; 1460-D/2009, of December 31; and 283/2010, of May 25). The latest measures implemented prior to 2011 focused on the generalization and broadening of the generic medicines use, provided their proven quality and obvious clinical and economic benefit to both the citizen and to the State. These actions entailed the establishment of new rules to determine the price of each new generic to enter a specific homogeneous group. The reference price associated with each homogeneous group was the average of the
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five lowest prices in this group (Decree-Law no. 48-A/2010, of May 13). In Portugal the prices of prescription medicines are regulated, being the prices of generics lower than the ones of branded medicines, partly through the design of price system controls.
2.3. Mitigation of barriers to the Portuguese market entry To facilitate the introduction of generics into the market as well as to increase market shares, the manufacture, marketing, and reimbursement of all pharmaceutical products for human use became regulated. According to Decree-Law no. 242/2000, of September 26, some concepts were updated and the reference “MG” in the packaging was introduced (MG stands for ‘medicamento genérico’, the Portuguese words for generic medicine). It should be remarked that, in Portugal, the generic medicines designation is different from other countries, as it should include the name of the holder of market authorization. Despite those measures, there were considerable (legal) barriers to the entry of new generics as well as the missing of incentives for physicians to promote the prescription of generics [6]. Some of these barriers included, but were not limited to, long administrative processes and the delay of INFARMED on accepting these new medicines (the acronym stands for Autoridade Nacional do Medicamento e Produtos de Saúde, I.P., the Portuguese words for National Medicines and Health Products Authority).
2.4. Creation of incentives to the prescription of generic medicines To increase the market share of generics, in 2002 one established that savings for the State would be applied in the form of incentives for institutions (e.g., investments) and prescribers (e.g., research, congresses, and scientific journals’ funding) (Order no. 7145/2002, of 7 March).
3. Medicines policy and regulation in Portugal during and after the Troika period
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3.1. Definition of prices The price setting process is no longer under the responsibility of the Ministry of Economy. Rather, it was handed down to the Ministry of Health, through INFARMED. One of INFARMED first actions was the annual revision of the reference-pricing system based on international prices by changing the reference countries to the three EU countries with the lowest price levels or, instead, EU countries with comparable GDP per capita levels. Additionally, the price of generics introduced into the Portuguese pharmaceutical market could not be larger than half of the price associated with the branded product with similar active ingredient. The price of medicines without patent protection and/or without generic substitutes on the Portuguese market also saw a reduction by half. Monthly monitoring of spending on medications was also initiated to ensure full compliance with targets for expenditure (1.25 % GDP in 2012 and 1% GDP in following years). To implement this measure, some agreements were reached with the pharmaceutical industry with a ceiling of D 2 million of public spending, with payback rights whenever the amount was exceeded. The introduction of innovative medicines was eased to “reimburse” the pharmaceutical industry for some potential loss of profits. 3.2. Prescriptions and their monitoring The electronic prescription of medicines (by INN) by physicians working either on the public or the private sectors has been consolidated and made compulsory. With this measure, in 2013, Portugal joined the group of European countries that instituted mandatory prescription by INN: Greece, Estonia, Latvia, Lithuania, and Romania [13]. By this time, the Directorate-General for Health established some rules for the prescription of medicines based on international guidelines, in order to guide the prescribing doctors. The implementation of a monitoring system with periodic issuance of a detailed report per prescribing doctor came then as a novelty. This report contains information about each doctor’s prescription pattern (especially regarding the most expensive and/or widely prescribed medicines). 3.3. On promoting the prescription of generic medicines
As a counterpart to the foreign aid given to Portugal in 2011, a Memorandum of Understanding was designed by both the Portuguese government and Troika. Such a document guided the reform processes in the most varied areas of Public Administration. The objective would be to reduce public spending and to induce sustainability based on the search for greater efficiency. For a survey, please see Nunes et al. [10] as well as Nunes and Ferreira [7,8]). Part of the effort imposed over the public sector focused on the health sector and, particularly, on the pharmaceutical market, where the public spending was considerable. According to Ginsburg [12], the pharmaceutical sector is typically an attractive area and with scope for progressive reduction of costs, including during financial crises. However, the author warns that blind cuts on public spending should be avoided. Instead, this spending reduction should be negotiated with pharmaceutical companies, never threatening the users’ access to the appropriate medicines. This principle was undertaken by the Memorandum of Understanding, through the clustering of the main policies over the pharmaceutical sector into five groups: (1) definition of prices; (2) prescription and monitoring; (3) promotion of the generic medicines; (4) pharmacies; and (5) corruption monitoring and expunging. Because the last two are out of scope of this study, they will not be analysed below.
An ambitious target of 60 % volume-based market share for (outpatient) generic medicines was foreseen during the external financial aid period. The applied measures included the removal of legal and regulatory barriers to the entry of new generics (by reducing administrative/legal hurdles to speed up the reimbursement of generics) and the induction of doctors to prescribe both generic and cheaper brand-name medicines (Law no. 62 / 2011). The abovementioned electronic prescription for INNs is itself a factor inducing the prescription of generics since it has allowed, on the one hand, the dissociation between trade names (brands) from certain pathologies and, on the other hand, the promotion of competitiveness between producers of generic medicines [9]. In fact, at the time of delivery of the medicinal product, the pharmacist is obliged to inform the user of the existence of generic medicines with the same active substance, dosage form, presentation, and dosage, and to store, at least, three out of the five lowest cost medicines. Thus, with the due exceptions, the user starts exercising her/his right of option [14]. A process of monitoring the market share of generic medicines by region and by pharmacy was carried out to evaluate the results of these measures. Results are, then, made available in the internet (Order no. 17069/2011, of December 21).
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By the end of 2015, in the post-crisis period, a new constitutional government established a programme based on the promotion of a sustainable policy for both brand-name and generic medicines, trying to reconcile the budgetary rigor with the access to innovative therapies and medicines (Portugal, 2015). Some approaches were adopted to combat fraud and to reinforce both the mandatory electronic prescription by INN and the switching from brand-name to generic medicines in such prescriptions. In addition, agreements were reached with the pharmaceutical industry, with a ceiling of D 2 billion being set (continued compensation for innovative medicines through the approval of reimbursement procedures).The system of notified prices for medicines not reimbursed by the NHS was also implemented and the price revision in an annual basis through international comparison with different reference countries was continued (in 2017 those countries included Spain, France, and Italy). Some policies initiated in the period of crisis were maintained to promote the increase of the generic medicines’ market share. In addition, the literacy about them was strengthened for both citizens and health professionals, highlighting the advantages of using generic medicines for the sake of the NHS sustainability. In terms of monitoring, the issuance of reports per physician was kept and the information about both the prescribed medicines use and expense was made available online in the NHS website.
4. Evidence from Portugal, 2010-onwards In this section, we analyse whether the changes indorsed during and after the austerity period have succeeded in boosting the use of generics. However, prior than answering to such a question, we highlight that the compulsory electronic prescription of all prescription medicines and the implementation of prescription by INN, with due exceptions, took effect in 2016. Accordingly, that year, about 99 % of prescriptions were electronic. Therefore, this strategy was successful as it did mitigate duplication of medical prescriptions [15] and fraud attempts [10]. Fig. 1 portrays the evolution of the market share associated with generics in Portugal since 2010. As shown, since the publication of the new prescription and delivery rules for medicines in 2012, the volume-based share of generics in this market increased by 10.3 % to reach 46.5 % in 2014, well below the goal of 60 %. This slow growth was criticized by the European Commission, advocating the need to press physicians on prescribing generic medicines (European Commission, 2014). Such measures were only implemented in 2017, but data from Fig. 1 suggest that the gains were not significant. In fact, the market share grew very slightly, 1 p.p./year, even after the approval of reimbursement for 493 generic medicines. In terms of expenditure, the generics market share did not significantly change (less than 1% change even after seven years) [15]. These results suggest the existence of some difficulties on applying new prescription rules among the medical community but also some resistance of citizens and/or health professionals to purchase/prescribe/dispense this kind of medicines. Regarding the generics market share (based on volume), nearly half of prescriptions were due to primary health care, public hospitals, and private hospitals [16]. During the austerity period, there was an increase of 70 % in the total number of generic medicines on the market, as nearly five new non-patented medicines entered the market per brand-name medicine that went out. However, 52.8 % (D 613 million) of public expenditures with prescriptions referred to medicines whose INNs did not have generics available by 2014. One of the most debated issues on this topic is the acceptance of the generic by the users. It is important to mention that this resistance to change is often motivated by their total lack of knowledge regarding the generic medicine and its definition [17–20]. For
instance, in Italy 59 % of respondents claim to know and use generics medicines [21]. In Portugal, a survey to 300 citizens allowed to conclude that most of them (95 %) have already consumed generics, but only 45 % of the surveyed correctly know the definition of those medicines. The remaining 55 % have doubts about their effectiveness [22]. As for costs, the generic option should be attractive to users since it usually has a lower acquisition cost. According to the survey conducted by Nunes and Ferreira [22], all inquired citizens confirm that generics are cheaper than branded medicines and, for 70 % of the former, it is the determinant factor during purchase. Existing copayments, for example, are a way to encourage people to consider the cost of medication to use less expensive medicines, such as generics [23]. However, there are some stereotypes and doubts about the efficacy of generic medicines when compared to the equivalent brand-name ones. Usually due to unfamiliarity, users may think that generics and brand-name medicines are not bioequivalent, ergo leading to distinct and undesirable outcomes, thus casting doubts about the generic medicines’ efficacy. This is an important conclusion drawn by Straka et al. [24] after a literature review of thirty studies related to potential clinical and economic impact of switching branded medicines to generics. Another remarkable study evaluated the attitudes of patients regarding such a switch in several European countries, whose population share some behavioural features with the Portuguese citizens (including Spanish and French people): when evaluating the acceptability of antiepileptic brand-name medicines switching to generics, Haskins et al. [25] concluded that both patients and doctors, “with concern over increased breakthrough seizure risk”. Note that, according to the Portuguese and European legislations, generic medicines have to be bioequivalent to reference medicines, but not exactly equal. Some authors mention the negative beliefs about the (absent) side effects theoretically associated with the generics as a reason for the missing of trust [26–29]. The prescribing doctor and the pharmacist both play here a decisive role inducing the behaviour of the user on purchasing either the generic or the brand-name medicine [30]. In the case of Greece, for example, Balasopoulos et al. [31] found that confidence in medical staff is positively and statistically related to the perceptions of users in terms of generics safety. Health literacy programmes especially focused on the citizen, caregivers, and pharmacists should then be implemented [32]. Even though envisaged in the memorandum of understanding, the payment of additional remuneration to pharmacies for the promotion of generic medicines was not implemented. Only since the beginning of 2017, pharmacies were given a specific fee (D 0.35 per package) to maintain the objective of increasing the delivery of reimbursed generic medicines (Ordinance No. 262/2016, of October 7). Although allowed since 2000 (Law no. 14/2000, of August 8), the substitution of brand-name medicines by generics in the pharmacy at the option of the patient (with prior authorization of the physician) did not have an expressive acceptance for the reasons above. That authorization is no longer necessary since 2012, with the publication of the Law no. 11/2012, of March 8, which makes the acquisition of generics only the users’ option. Table 1 analyses the implemented policies, distinguishing the expected impact of the actual impact and the degree of execution in terms of access, efficiency, accountability, and cost containment.
5. Some lessons from the Portuguese experience As previously noted, despite the steps undertaken to promote generics, results did not meet the objectives set out in the mem-
Please cite this article in press as: Nunes AM, et al. The Portuguese generic medicines market: What’s next? Health Policy (2020), https://doi.org/10.1016/j.healthpol.2020.02.014
Year
To fight against corruption and improve the monitoring system of prescription of medicines and diagnostic To fight against corruption and create the Invoice Conference Centre (inspection unit) To introduce regular (quarterly) feedback to physicians in terms of prescription of the costliest and widely used medicines To induce physicians to prescribe generic medicines and the less costly available branded product (target of 60 % market share for generics) To remove all entry barriers for generics
2012
Effective changes of implementation Access
Efficiency
Cost containment
Costs containment
–
(?) Lack of evidence
(-) Goal not reached; generics market share close to 50 %
Costs containment and reduction of out-of-pocket payments
(+) Positive as the access improved given the smaller price
–
(+) Positive as the benchmarking exercise became fairer
To reduce public expenditures with medicines, without hampering the access
(+) Positive
(+) More efficient management of medicines expenditure on the market
(+) Positive
To regulate pharmacies
(+) Better access of citizens to cheaper medicines –
–
–
(?) Lack of evidence – not implemented
(?) Lack of evidence – not implemented
To revise the profit margins of pharmacies
To improve accountability and access To integrate the whole prescription system
(+) Better access as citizens receive prescriptions via text message
(+) Waste reduction in terms of printed/ duplicated prescriptions; lower errors due to the difficulty on understanding the prescriber’s handwriting
(+) Cost savings and higher transparency and accountability
To improve accountability and medicines/diagnostic monitoring
–
(+) Mitigated fraud and duplicated prescriptions
(+) Prescription of what the user really needs
(?) Lack of evidence - random inspection not covering the entire system (?) Lack of evidence
2013
–
2013
(-) Meaningless impact
(?) Lack of evidence
(+) Better access to generics, cheaper than branded ones (-) Target of 60 % market share was not achieved (+) Better access to generics
(+) Higher efficiency, promoting sustainability of the public sector
2012
2013
To promote the generics and to reduce public expenditures with medicines
(+) Cost containments per prescription
(+) Less barriers to entry
Source: the authors.
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(I) Pricing and reimbursement of pharmaceuticals 2011 To set the maximum price of the first generic introduced in the market to 60 % of the branded product with similar active substance 2011 To revise the existing reference-pricing system based on international prices by changing the countries of reference to the three EU countries with the lowest price levels or countries with comparable GDP per capita levels 2011 To define a ceiling of the annual expenditure with medicines, with a payback fixed in expense of more than D 2 billion (II) Pharmacies sector 2012 To effectively implement the existing legislation regulating pharmacies 2012 To change the computation of profit margin into a regressive mark-up and a flat fee for wholesale companies and pharmacies (III) Prescriptions and their monitoring 2012 To impose electronic prescription for medicines in public sector To impose electronic prescription for 2013 medicines in public sector
Intended changes
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Table 1 Impact of major reform measures implemented in the medicines’ sector (2011–2014) in Portugal.
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Fig. 1. Evolution of the generics’ market share in Portugal. Sources: SNS [15] and INFARMED website (https://www.infarmed.pt/).
orandum of understanding (60 % of volume-based market share for generics), even in the post-crisis period featured by reinforced measures and incentives to pharmacies. Based on the previous discussion and according to the opinion of some experts in the pharmaceutical market, we present some suggestions for policies that may contribute to the increase of the use of generic medicines in Portugal. Their implementation is hampered by the fact that many of the measures employed in other countries are already underway and so we focus on weaknesses identified notably at the level of communication and incentives. 5.1. To create incentives for pharmacies to promote substitution To continue and strengthen the policy of incentives to pharmacies for the promotion of generic medicines, not only based on the number of packaging but as a share of the value, penalizing the substitution of generics for others more expensive medicines without proper justification. 5.2. To create incentives for physicians to promote substitution Assign a performance payment system to primary health care institutions associated with the volume of generic prescription. The amount will represent a part of the related savings that can be delivered to that health unit, which should be destined to investments. Training actions (e.g., funding for research, congresses, and scientific journals) for health professionals could also be promoted, as had already been envisaged (Order no. 7145/2002, of March 07), although rarely applied. 5.3. To apply a different pricing rule for generics The introduction of reference prices seems to have been effective in increasing generics use in Portugal. However, it must be continued, and one should ensure that new generics can achieve more attractive and competitive prices with higher margins than branded medicines. One of the solutions could be to reduce the costs of generics distribution. 5.4. To lessen the citizens’ concerns about safety and efficacy through communication There is also a need to promote measures to address concerns about the safety and efficacy of generics, not only among users but also among health professionals (doctors, nurses, pharmacists).
5.5. To apply the therapeutic management at the level of primary health care and pharmacies The patient should have a health professional (physicians, nurses, and pharmacists) who will help her/him to manage medication, teaching how to take and checking for duplication of prescription. Some (if not all) of these ideas can be adopted by other countries. We recall the 2017 Valletta Declaration signed by ten European countries (Portugal, Spain, Italy, Greece, Ireland, Cyprus, Croatia, Malta, Romania, and Slovenia) that sought to build an aggregated joint market for medicines commercialisation and, as such, to warrantee the citizens’ access to innovative medicines, to explore synergies between the signatory States, and to ensure their health systems’ financial sustainability. In Portugal, by virtue of this declaration, a technical commission was created to explore various strategies and models of voluntary cooperation which include, among others, information sharing, identification of best practices, the evaluation of innovative medicines and treatments, exploring possible mechanisms for price negotiation and joint procurement. 6. Concluding remarks This article aimed at evaluating the policies implemented in the past few years regarding the generics and their market in Portugal, highlighting some issues such as prescription, incentives, and dispensation. In Portugal, the adopted policies in this sector mainly sought to increase the market share of generics, as early as this century, although without significant results. Since 2011, in the midst of austerity policy, the measures applied to the pharmaceutical sector intended at obtaining cost savings and reducing financial waste. Although the results for the generic medicines have been positive with an increase in market share, that figure fell short of the target imposed by the memorandum of understanding. It can therefore be said that the participation of generics in the Portuguese pharmaceutical market at the end of the austerity period did not keep up with the high expectations. A policy of continued promotion of the generic medicine was carried out in the post-crisis period (2015-onwards), but results to date are still modest. We have discussed the results obtained after those policies implementation and have found that, since the end of the austerity period, incentives to pharmacies have been lacking to compensate them for the distribution of the generic medicines (those measures adopted in January 2017 are not very motivating). On the one hand, brand-name medicines are still more lucrative. There is also
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a lack of incentives for primary health care centres (namely, the physicians prescribing medicines to the outpatients) to promote the prescription of generics. On the other hand, we have found that it is necessary to familiarize users and health professionals by elucidating them about the efficacy, quality and similarities of generics compared to the brand-name medicines to improve the former prescription and reinforce the right of option at the time of purchase. With this, we conclude that the essential measures to promote generics have already been taken. It is now compulsory to reinforce them and to monitor their outcomes by taking additional initiatives to achieve the objectives for which they were created. From the above, we argue, as recommendation, that incentives based on payments to pharmacies should be adjusted to increase the efficiency of the substitution process. In addition, pharmacies may be allowed to perform some health services and activities of counselling, health promotion, and disease prevention through a contract with the NHS for specific cases of users with needs and whose primary health services are unable to respond. Additionally, we suggest that the price rule for generics should be revised so that pharmacies are not financially penalized for dispensing them. Finally, we also suggest a review of the regulatory framework so that concerns about the safety and efficacy of generic medicines are overcome. The future prospect foresees that Portugal will further increase the market share of the generic, achieving additional satisfactory results and contributing certainly to the sustainability of the NHS and to the reduction of out-of-pocket costs, keeping the same effectiveness and quality of brand-name medicines. Declaration of Competing Interest None. Acknowledgements The second author gratefully acknowledges the generous financial support of the project ‘hSNS: Portuguese public hospital performance assessment using a multi-criteria decision analysis framework’ (PTDC/EGE-OGE/30546/2017), funded by the Portuguese Foundation for Science and Technology (FCT, from the Portuguese abbreviation of Fundac¸ão para a Ciência e a Tecnologia). References [1] Shah U. Regulatory strategies and lessons in the development of biosimilars. In: Wang W, Singh M, editors. Biological drug products: development and strategies. Nova Jersey: John Wiley & Sons; 2014. p. 367–410. [2] Nardi R, Masina M, Cioni G, Leandri P, Zuccheri P. Generic equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world. Italian Journal of Medicine 2014;8(2):88–98. [3] Bate R, Jin G, Mathur A. Does price reveal poor-quality drugs? Evidence from 17 countries. Journal of Health Economics 2011;30(6):1150–63. [4] Xanthopoulou SS, Katsaliaki K. Policies and perceptions on generic drugs: the case of Greece. Health Services Management Research 2018, http://dx.doi.org/ 10.1177/0951484817752630. [5] OECD. Share of generic market for pharmaceuticals. In: Health at a glance: Europe 2016: state of health in the EU cycle. Paris: OECD Publishing; 2016, http://dx.doi.org/10.1787/health glance eur-2016-64-en. [6] Coelho S. Percepc¸ão e comportamento dos consumidores portugueses relativamente aos medicamentos genéricos [Perception and behavior of Portuguese consumers regarding generic medicines]. Lisboa: Instituto Universitário; 2010. [7] Nunes AM, Ferreira DC. Reforms in the Portuguese health care sector: challenges and proposals. The International Journal of Health Planning and Management 2018;34(1):e21–33.
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The Portuguese generic medicines market: What’s next? Alexandre Morais Nunes a,b , Diogo Cunha Ferreira b,∗ , Andreia de Matos a , Rui Miranda Julião a a b
CAPP, Instituto Superior de Ciências Sociais e Políticas, University of Lisbon, R. Almerindo Lessa, 1300-663 Lisbon, Portugal CERIS, Instituto Superior Técnico, University of Lisbon, Av. Rovisco Pais, 1049-001 Lisbon, Portugal
a r t i c l e
i n f o
Article history: Received 20 June 2019 Received in revised form 11 January 2020 Accepted 24 February 2020 Keywords: Generics Portugal Economic crisis Broadening use of generics
a b s t r a c t Brand-name medicines have dominated the Portuguese market for several decades with unquestionable exclusivity. This resulted particularly from the absence of a requirement of prescriptions by international non-proprietary name. To promote the enhancement of both efficiency and sustainability in the health system, the Portuguese government introduced the generics in Portugal by the 90 s. However, only in the first decade of the 21st century were some policies implemented to increase their market share. Although some expectations were created, the use of generics has increased moderately during that period, in which policies to promote them were consolidated by imposing the austerity principles in the midst of the economic and social crisis. This study analyses the main policy measures already implemented as well as the incentives created for the replacement of brand-name medicines with generics. In addition, the present study also makes some recommendations to promote a broader and better use of generics in Portugal. © 2020 Elsevier B.V. All rights reserved.
1. Introduction Over the past few decades and even with some implemented policy and regulatory measures, brand-name medicines have dominated the Portuguese pharmaceutical market almost exclusively. Generic medicines (or simply generics) were insignificant in this market until a few years ago. Nevertheless, the use of generics has been recognized in the literature for their safety, quality, and efficacy, which are as high as brand-name medicines [1,2]. Also, promoting the consumption of generics contributes to the rational use of medicines and generates cost savings for both users and health systems [3,4], including those based on a National Health Service (NHS), funded from a general state budget. Portugal and the UK are two examples of countries following this health system organization. Although some measures promoting the commercialization of generics have been endorsed since the beginning of the 21st century, Portugal has still a volume-based market share of generics of nearly 48.4 % in 2018, which compares to 31.4 % in 2010 and 41.4 % in 2015. Note that the Portuguese pharmaceutical market in 2018
∗ Corresponding author. E-mail addresses: [email protected] (A.M. Nunes), [email protected] (D.C. Ferreira), [email protected] (A. de Matos), [email protected] (R.M. Julião).
was D 2460 million or 220 million units sold. Even with a considerable market share growth in the past few years, Portugal is still far from other European countries, like Germany (80–81 %), UK (83–84 %), and Netherlands (70–71 %) – data from 2013 and 2014 [33,5]). The lack of prescription of this type of medicines by physicians and the distrust of users regarding its efficacy and safety help to justify such a low market share in Portugal [6]. The measures employed to promote generics in Portugal were consolidated by imposition of the Memorandum of Understanding applied in Portugal by 2011. In fact, this year external assistance was requested from the International Monetary Fund, the European Central Bank, and the European Commission, composing the triumvirate commonly known as Troika [7]. By this time, Portugal was facing a period of economic and social crisis that resulted from serious financial problems. As a result of the increase in public spending, those problems led to a fall in Gross Domestic Product (GDP) by 4.4 % (the average of the 28 EU countries grew by 2.9 % in the same period). This has hampered the credibility of Portugal within international markets, with the consequent worsening of sovereign debt interest rates, which have reached unacceptable levels [8]. Based on this panorama and financing problems, Troika concluded that the best way to overcome the crisis would be through a policy based on strong austerity measures aimed at reducing excessive and inefficient spending [9]. In the implementation of
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this objective, a reform was carried out based on cuts in spending and the promotion of greater efficiency [9,10]. In the years leading up to the financial crisis, and according to OECD data, pharmaceutical spending was one of the highest spending on health, under a continuous growth. In 2004, those expenses amounted to D 3163 million (21.1 % of the current spending with health), which grew by nearly 8% until 2010 to D 3404 million (18.1 %). In terms of spending per capita, those figures result into D 446 in 2004 and D 518 in 2010 (+16 %). Furthermore, expenditure on medicines accounted for 17.7 % of total expenditures with health in Portugal, from which 55.9 % were borne by the State. Given these high costs due to the pharmaceutical sector and the Troika request to reduce public health expenditure, this was a target area to promote efficiency gains (Ginsburg, 2014). In the Portuguese case, they would result from reducing the high costs often associated with corruption, inefficiency, and the policy related to the pharmaceutical market – including the slow pace of generics entry into the pharmaceutical market, no mandatory electronic prescription, and the lack of generalization of the International non-proprietary name (INN) prescription [11]. To increase the use of generic medicines in Portugal, successive governments have implemented several policies in the past few years, including (1) the mandatory requirement for INN prescription, (2) the adjustment of the price of the generic medicine marketed, at the most, by half of the price of the brand-name medicine with the same active ingredient, and (3) the improvement of the substitution process, making it easier. Such policies were expected to substantially increase the share of generics in the austerity period up to 60 % in terms of ambulatory market volume, which was clearly an ambitious goal given the market share of these medicines in Portugal prior the crisis period. In addition to the promotion of generic medicines selling, the Memorandum of Understanding signed between the Portuguese Government and the Troika provided for further medicines policy, namely the introduction of innovative medicines, the re-definition of prices, the reimbursement of pharmaceutical products, the monitoring of prescriptions, the fight against corruption, and the implementation of new legislation for pharmacies. Although there exist several measures underway in the Portuguese pharmaceutical sector, the present study concentrates on the ones promoting the generics’ market share increasing, since it is a transversal measure started at the end of the 20th century, with sufficient time for consolidation. This article analyses the main policy measures implemented as well as the incentives created to replace brand-name medicines by generic medicines. In addition, and in line with those measures, we make some recommendations to indorse a broader and better use of generic medicines in Portugal. The paper is structured as follows. Section 2 reviews the generic medicines’ prescription measures implemented in the past (until 2011). Section 3 presents the medicines-related policies executed during and after the austerity period (2011-onwards). Section 4 presents and discusses the main results attained by policies trying to raise the market share of generic medicines in Portugal. Section 5 identifies some recommendations for future policies in the sector. Finally, section 6 concludes the study.
2. The generic medicines market in Portugal before 2011 The introduction of generics in the Portuguese market resulted from the Medicines Statute of 1990. This law regulates the life cycle of all medicines in Portugal, ergo characterizing the generic medicine, presenting its benefits to the user and establishing that the prescription should be restricted to the generic name or to the INN of the active ingredients. With the amendment to that statute in 1998, it is now required to indicate the dosage form in
generic medicines. Since the end of the 90 s, several actions have been undertaken to put generics forward, raising their consumption. These actions can be clustered in terms of: (1) prescriptions and out-of-pocket payments; (2) definition of prices; (3) mitigation of barriers to the entry of generic medicines; and (4) creation of incentives to the prescription of these medicines. 2.1. Prescriptions and out-of-pocket payments In the first decade of the 21st century, several rationalization policies were implemented in the prescription of medicines, e.g. the monitoring of INN prescriptions, and the improvement of the citizens literacy regarding the existence of generics as an additional option, when the prescriber physician does not opt by a specific brand-name (Law no. 14/2000, of August 8). In 2002, due to non-compliance of physicians with the prescription regulation, it was necessary to induce the (mandatory) requirement for INN prescriptions. However, reference to the brand-name was still allowed. Therefore, it became compulsory to inform the user about the existence of a biosimilar generic medicine as well as its lower price compared to the brand-name medicine (Decree-Law no. 271/2002, of 2 December). In 2010, the reimbursement rules related to medicines selling were changed. Since then, the State reimburses electronic prescription, in a strategy to reduce public spending through the association between INN prescription and consumption of generics. 2.2. On defining the prices for generics In 2000, the Portuguese government defined the State’s share of the medicines price. This year, the 10 % mark-up was introduced for all generics. That amount would increase to 15 % for the cases of lower household income (Decree-Law no. 205/2000, of 01 September). In 2001, a special price regime for generic medicines was established: the price of a generic medicine could not be larger than 65 % of the price associated with the brand-name medicine with equal dosage and in the same dosage form (Ordinance no. 577/2001, of June 7). In 2002, the policy of the medicinal product concerned the reference price system introduction and application to the medicines belonging to the same homogeneous group, i.e., those with the same qualitative and quantitative composition as active substance, dosage form, dosage and route of administration including at least one generic medicine with market authorization. The reference price is calculated based on the most expensive generic of its own group (Decree-Law no. 270/2002, of 2 December). Later, in 2008, the Decree-Law no. 1184/2008 and the Ordinance No. 1016-A/2008, of September 8, sought to gradually reduce the maximum sale prices associated with medicines. Accordingly, it should be possible to reduce the retail price of generics by 30 %. Exceptions include the generic medicines sold by less than D 5 as well as the cases in which the reduction would result into a selling price of less than half of the reference (brand-name) product. This measure has, however, been revised over the years (up to 2011) in order to continue the attempt of reducing prices (Ordinances 1551/2008, of December 31; 668/2009, of June 19; 1047/2009, of September 15; 1460-D/2009, of December 31; and 283/2010, of May 25). The latest measures implemented prior to 2011 focused on the generalization and broadening of the generic medicines use, provided their proven quality and obvious clinical and economic benefit to both the citizen and to the State. These actions entailed the establishment of new rules to determine the price of each new generic to enter a specific homogeneous group. The reference price associated with each homogeneous group was the average of the
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five lowest prices in this group (Decree-Law no. 48-A/2010, of May 13). In Portugal the prices of prescription medicines are regulated, being the prices of generics lower than the ones of branded medicines, partly through the design of price system controls.
2.3. Mitigation of barriers to the Portuguese market entry To facilitate the introduction of generics into the market as well as to increase market shares, the manufacture, marketing, and reimbursement of all pharmaceutical products for human use became regulated. According to Decree-Law no. 242/2000, of September 26, some concepts were updated and the reference “MG” in the packaging was introduced (MG stands for ‘medicamento genérico’, the Portuguese words for generic medicine). It should be remarked that, in Portugal, the generic medicines designation is different from other countries, as it should include the name of the holder of market authorization. Despite those measures, there were considerable (legal) barriers to the entry of new generics as well as the missing of incentives for physicians to promote the prescription of generics [6]. Some of these barriers included, but were not limited to, long administrative processes and the delay of INFARMED on accepting these new medicines (the acronym stands for Autoridade Nacional do Medicamento e Produtos de Saúde, I.P., the Portuguese words for National Medicines and Health Products Authority).
2.4. Creation of incentives to the prescription of generic medicines To increase the market share of generics, in 2002 one established that savings for the State would be applied in the form of incentives for institutions (e.g., investments) and prescribers (e.g., research, congresses, and scientific journals’ funding) (Order no. 7145/2002, of 7 March).
3. Medicines policy and regulation in Portugal during and after the Troika period
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3.1. Definition of prices The price setting process is no longer under the responsibility of the Ministry of Economy. Rather, it was handed down to the Ministry of Health, through INFARMED. One of INFARMED first actions was the annual revision of the reference-pricing system based on international prices by changing the reference countries to the three EU countries with the lowest price levels or, instead, EU countries with comparable GDP per capita levels. Additionally, the price of generics introduced into the Portuguese pharmaceutical market could not be larger than half of the price associated with the branded product with similar active ingredient. The price of medicines without patent protection and/or without generic substitutes on the Portuguese market also saw a reduction by half. Monthly monitoring of spending on medications was also initiated to ensure full compliance with targets for expenditure (1.25 % GDP in 2012 and 1% GDP in following years). To implement this measure, some agreements were reached with the pharmaceutical industry with a ceiling of D 2 million of public spending, with payback rights whenever the amount was exceeded. The introduction of innovative medicines was eased to “reimburse” the pharmaceutical industry for some potential loss of profits. 3.2. Prescriptions and their monitoring The electronic prescription of medicines (by INN) by physicians working either on the public or the private sectors has been consolidated and made compulsory. With this measure, in 2013, Portugal joined the group of European countries that instituted mandatory prescription by INN: Greece, Estonia, Latvia, Lithuania, and Romania [13]. By this time, the Directorate-General for Health established some rules for the prescription of medicines based on international guidelines, in order to guide the prescribing doctors. The implementation of a monitoring system with periodic issuance of a detailed report per prescribing doctor came then as a novelty. This report contains information about each doctor’s prescription pattern (especially regarding the most expensive and/or widely prescribed medicines). 3.3. On promoting the prescription of generic medicines
As a counterpart to the foreign aid given to Portugal in 2011, a Memorandum of Understanding was designed by both the Portuguese government and Troika. Such a document guided the reform processes in the most varied areas of Public Administration. The objective would be to reduce public spending and to induce sustainability based on the search for greater efficiency. For a survey, please see Nunes et al. [10] as well as Nunes and Ferreira [7,8]). Part of the effort imposed over the public sector focused on the health sector and, particularly, on the pharmaceutical market, where the public spending was considerable. According to Ginsburg [12], the pharmaceutical sector is typically an attractive area and with scope for progressive reduction of costs, including during financial crises. However, the author warns that blind cuts on public spending should be avoided. Instead, this spending reduction should be negotiated with pharmaceutical companies, never threatening the users’ access to the appropriate medicines. This principle was undertaken by the Memorandum of Understanding, through the clustering of the main policies over the pharmaceutical sector into five groups: (1) definition of prices; (2) prescription and monitoring; (3) promotion of the generic medicines; (4) pharmacies; and (5) corruption monitoring and expunging. Because the last two are out of scope of this study, they will not be analysed below.
An ambitious target of 60 % volume-based market share for (outpatient) generic medicines was foreseen during the external financial aid period. The applied measures included the removal of legal and regulatory barriers to the entry of new generics (by reducing administrative/legal hurdles to speed up the reimbursement of generics) and the induction of doctors to prescribe both generic and cheaper brand-name medicines (Law no. 62 / 2011). The abovementioned electronic prescription for INNs is itself a factor inducing the prescription of generics since it has allowed, on the one hand, the dissociation between trade names (brands) from certain pathologies and, on the other hand, the promotion of competitiveness between producers of generic medicines [9]. In fact, at the time of delivery of the medicinal product, the pharmacist is obliged to inform the user of the existence of generic medicines with the same active substance, dosage form, presentation, and dosage, and to store, at least, three out of the five lowest cost medicines. Thus, with the due exceptions, the user starts exercising her/his right of option [14]. A process of monitoring the market share of generic medicines by region and by pharmacy was carried out to evaluate the results of these measures. Results are, then, made available in the internet (Order no. 17069/2011, of December 21).
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By the end of 2015, in the post-crisis period, a new constitutional government established a programme based on the promotion of a sustainable policy for both brand-name and generic medicines, trying to reconcile the budgetary rigor with the access to innovative therapies and medicines (Portugal, 2015). Some approaches were adopted to combat fraud and to reinforce both the mandatory electronic prescription by INN and the switching from brand-name to generic medicines in such prescriptions. In addition, agreements were reached with the pharmaceutical industry, with a ceiling of D 2 billion being set (continued compensation for innovative medicines through the approval of reimbursement procedures).The system of notified prices for medicines not reimbursed by the NHS was also implemented and the price revision in an annual basis through international comparison with different reference countries was continued (in 2017 those countries included Spain, France, and Italy). Some policies initiated in the period of crisis were maintained to promote the increase of the generic medicines’ market share. In addition, the literacy about them was strengthened for both citizens and health professionals, highlighting the advantages of using generic medicines for the sake of the NHS sustainability. In terms of monitoring, the issuance of reports per physician was kept and the information about both the prescribed medicines use and expense was made available online in the NHS website.
4. Evidence from Portugal, 2010-onwards In this section, we analyse whether the changes indorsed during and after the austerity period have succeeded in boosting the use of generics. However, prior than answering to such a question, we highlight that the compulsory electronic prescription of all prescription medicines and the implementation of prescription by INN, with due exceptions, took effect in 2016. Accordingly, that year, about 99 % of prescriptions were electronic. Therefore, this strategy was successful as it did mitigate duplication of medical prescriptions [15] and fraud attempts [10]. Fig. 1 portrays the evolution of the market share associated with generics in Portugal since 2010. As shown, since the publication of the new prescription and delivery rules for medicines in 2012, the volume-based share of generics in this market increased by 10.3 % to reach 46.5 % in 2014, well below the goal of 60 %. This slow growth was criticized by the European Commission, advocating the need to press physicians on prescribing generic medicines (European Commission, 2014). Such measures were only implemented in 2017, but data from Fig. 1 suggest that the gains were not significant. In fact, the market share grew very slightly, 1 p.p./year, even after the approval of reimbursement for 493 generic medicines. In terms of expenditure, the generics market share did not significantly change (less than 1% change even after seven years) [15]. These results suggest the existence of some difficulties on applying new prescription rules among the medical community but also some resistance of citizens and/or health professionals to purchase/prescribe/dispense this kind of medicines. Regarding the generics market share (based on volume), nearly half of prescriptions were due to primary health care, public hospitals, and private hospitals [16]. During the austerity period, there was an increase of 70 % in the total number of generic medicines on the market, as nearly five new non-patented medicines entered the market per brand-name medicine that went out. However, 52.8 % (D 613 million) of public expenditures with prescriptions referred to medicines whose INNs did not have generics available by 2014. One of the most debated issues on this topic is the acceptance of the generic by the users. It is important to mention that this resistance to change is often motivated by their total lack of knowledge regarding the generic medicine and its definition [17–20]. For
instance, in Italy 59 % of respondents claim to know and use generics medicines [21]. In Portugal, a survey to 300 citizens allowed to conclude that most of them (95 %) have already consumed generics, but only 45 % of the surveyed correctly know the definition of those medicines. The remaining 55 % have doubts about their effectiveness [22]. As for costs, the generic option should be attractive to users since it usually has a lower acquisition cost. According to the survey conducted by Nunes and Ferreira [22], all inquired citizens confirm that generics are cheaper than branded medicines and, for 70 % of the former, it is the determinant factor during purchase. Existing copayments, for example, are a way to encourage people to consider the cost of medication to use less expensive medicines, such as generics [23]. However, there are some stereotypes and doubts about the efficacy of generic medicines when compared to the equivalent brand-name ones. Usually due to unfamiliarity, users may think that generics and brand-name medicines are not bioequivalent, ergo leading to distinct and undesirable outcomes, thus casting doubts about the generic medicines’ efficacy. This is an important conclusion drawn by Straka et al. [24] after a literature review of thirty studies related to potential clinical and economic impact of switching branded medicines to generics. Another remarkable study evaluated the attitudes of patients regarding such a switch in several European countries, whose population share some behavioural features with the Portuguese citizens (including Spanish and French people): when evaluating the acceptability of antiepileptic brand-name medicines switching to generics, Haskins et al. [25] concluded that both patients and doctors, “with concern over increased breakthrough seizure risk”. Note that, according to the Portuguese and European legislations, generic medicines have to be bioequivalent to reference medicines, but not exactly equal. Some authors mention the negative beliefs about the (absent) side effects theoretically associated with the generics as a reason for the missing of trust [26–29]. The prescribing doctor and the pharmacist both play here a decisive role inducing the behaviour of the user on purchasing either the generic or the brand-name medicine [30]. In the case of Greece, for example, Balasopoulos et al. [31] found that confidence in medical staff is positively and statistically related to the perceptions of users in terms of generics safety. Health literacy programmes especially focused on the citizen, caregivers, and pharmacists should then be implemented [32]. Even though envisaged in the memorandum of understanding, the payment of additional remuneration to pharmacies for the promotion of generic medicines was not implemented. Only since the beginning of 2017, pharmacies were given a specific fee (D 0.35 per package) to maintain the objective of increasing the delivery of reimbursed generic medicines (Ordinance No. 262/2016, of October 7). Although allowed since 2000 (Law no. 14/2000, of August 8), the substitution of brand-name medicines by generics in the pharmacy at the option of the patient (with prior authorization of the physician) did not have an expressive acceptance for the reasons above. That authorization is no longer necessary since 2012, with the publication of the Law no. 11/2012, of March 8, which makes the acquisition of generics only the users’ option. Table 1 analyses the implemented policies, distinguishing the expected impact of the actual impact and the degree of execution in terms of access, efficiency, accountability, and cost containment.
5. Some lessons from the Portuguese experience As previously noted, despite the steps undertaken to promote generics, results did not meet the objectives set out in the mem-
Please cite this article in press as: Nunes AM, et al. The Portuguese generic medicines market: What’s next? Health Policy (2020), https://doi.org/10.1016/j.healthpol.2020.02.014
Year
To fight against corruption and improve the monitoring system of prescription of medicines and diagnostic To fight against corruption and create the Invoice Conference Centre (inspection unit) To introduce regular (quarterly) feedback to physicians in terms of prescription of the costliest and widely used medicines To induce physicians to prescribe generic medicines and the less costly available branded product (target of 60 % market share for generics) To remove all entry barriers for generics
2012
Effective changes of implementation Access
Efficiency
Cost containment
Costs containment
–
(?) Lack of evidence
(-) Goal not reached; generics market share close to 50 %
Costs containment and reduction of out-of-pocket payments
(+) Positive as the access improved given the smaller price
–
(+) Positive as the benchmarking exercise became fairer
To reduce public expenditures with medicines, without hampering the access
(+) Positive
(+) More efficient management of medicines expenditure on the market
(+) Positive
To regulate pharmacies
(+) Better access of citizens to cheaper medicines –
–
–
(?) Lack of evidence – not implemented
(?) Lack of evidence – not implemented
To revise the profit margins of pharmacies
To improve accountability and access To integrate the whole prescription system
(+) Better access as citizens receive prescriptions via text message
(+) Waste reduction in terms of printed/ duplicated prescriptions; lower errors due to the difficulty on understanding the prescriber’s handwriting
(+) Cost savings and higher transparency and accountability
To improve accountability and medicines/diagnostic monitoring
–
(+) Mitigated fraud and duplicated prescriptions
(+) Prescription of what the user really needs
(?) Lack of evidence - random inspection not covering the entire system (?) Lack of evidence
2013
–
2013
(-) Meaningless impact
(?) Lack of evidence
(+) Better access to generics, cheaper than branded ones (-) Target of 60 % market share was not achieved (+) Better access to generics
(+) Higher efficiency, promoting sustainability of the public sector
2012
2013
To promote the generics and to reduce public expenditures with medicines
(+) Cost containments per prescription
(+) Less barriers to entry
Source: the authors.
ARTICLE IN PRESS
(I) Pricing and reimbursement of pharmaceuticals 2011 To set the maximum price of the first generic introduced in the market to 60 % of the branded product with similar active substance 2011 To revise the existing reference-pricing system based on international prices by changing the countries of reference to the three EU countries with the lowest price levels or countries with comparable GDP per capita levels 2011 To define a ceiling of the annual expenditure with medicines, with a payback fixed in expense of more than D 2 billion (II) Pharmacies sector 2012 To effectively implement the existing legislation regulating pharmacies 2012 To change the computation of profit margin into a regressive mark-up and a flat fee for wholesale companies and pharmacies (III) Prescriptions and their monitoring 2012 To impose electronic prescription for medicines in public sector To impose electronic prescription for 2013 medicines in public sector
Intended changes
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Please cite this article in press as: Nunes AM, et al. The Portuguese generic medicines market: What’s next? Health Policy (2020), https://doi.org/10.1016/j.healthpol.2020.02.014
Table 1 Impact of major reform measures implemented in the medicines’ sector (2011–2014) in Portugal.
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Fig. 1. Evolution of the generics’ market share in Portugal. Sources: SNS [15] and INFARMED website (https://www.infarmed.pt/).
orandum of understanding (60 % of volume-based market share for generics), even in the post-crisis period featured by reinforced measures and incentives to pharmacies. Based on the previous discussion and according to the opinion of some experts in the pharmaceutical market, we present some suggestions for policies that may contribute to the increase of the use of generic medicines in Portugal. Their implementation is hampered by the fact that many of the measures employed in other countries are already underway and so we focus on weaknesses identified notably at the level of communication and incentives. 5.1. To create incentives for pharmacies to promote substitution To continue and strengthen the policy of incentives to pharmacies for the promotion of generic medicines, not only based on the number of packaging but as a share of the value, penalizing the substitution of generics for others more expensive medicines without proper justification. 5.2. To create incentives for physicians to promote substitution Assign a performance payment system to primary health care institutions associated with the volume of generic prescription. The amount will represent a part of the related savings that can be delivered to that health unit, which should be destined to investments. Training actions (e.g., funding for research, congresses, and scientific journals) for health professionals could also be promoted, as had already been envisaged (Order no. 7145/2002, of March 07), although rarely applied. 5.3. To apply a different pricing rule for generics The introduction of reference prices seems to have been effective in increasing generics use in Portugal. However, it must be continued, and one should ensure that new generics can achieve more attractive and competitive prices with higher margins than branded medicines. One of the solutions could be to reduce the costs of generics distribution. 5.4. To lessen the citizens’ concerns about safety and efficacy through communication There is also a need to promote measures to address concerns about the safety and efficacy of generics, not only among users but also among health professionals (doctors, nurses, pharmacists).
5.5. To apply the therapeutic management at the level of primary health care and pharmacies The patient should have a health professional (physicians, nurses, and pharmacists) who will help her/him to manage medication, teaching how to take and checking for duplication of prescription. Some (if not all) of these ideas can be adopted by other countries. We recall the 2017 Valletta Declaration signed by ten European countries (Portugal, Spain, Italy, Greece, Ireland, Cyprus, Croatia, Malta, Romania, and Slovenia) that sought to build an aggregated joint market for medicines commercialisation and, as such, to warrantee the citizens’ access to innovative medicines, to explore synergies between the signatory States, and to ensure their health systems’ financial sustainability. In Portugal, by virtue of this declaration, a technical commission was created to explore various strategies and models of voluntary cooperation which include, among others, information sharing, identification of best practices, the evaluation of innovative medicines and treatments, exploring possible mechanisms for price negotiation and joint procurement. 6. Concluding remarks This article aimed at evaluating the policies implemented in the past few years regarding the generics and their market in Portugal, highlighting some issues such as prescription, incentives, and dispensation. In Portugal, the adopted policies in this sector mainly sought to increase the market share of generics, as early as this century, although without significant results. Since 2011, in the midst of austerity policy, the measures applied to the pharmaceutical sector intended at obtaining cost savings and reducing financial waste. Although the results for the generic medicines have been positive with an increase in market share, that figure fell short of the target imposed by the memorandum of understanding. It can therefore be said that the participation of generics in the Portuguese pharmaceutical market at the end of the austerity period did not keep up with the high expectations. A policy of continued promotion of the generic medicine was carried out in the post-crisis period (2015-onwards), but results to date are still modest. We have discussed the results obtained after those policies implementation and have found that, since the end of the austerity period, incentives to pharmacies have been lacking to compensate them for the distribution of the generic medicines (those measures adopted in January 2017 are not very motivating). On the one hand, brand-name medicines are still more lucrative. There is also
Please cite this article in press as: Nunes AM, et al. The Portuguese generic medicines market: What’s next? Health Policy (2020), https://doi.org/10.1016/j.healthpol.2020.02.014
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a lack of incentives for primary health care centres (namely, the physicians prescribing medicines to the outpatients) to promote the prescription of generics. On the other hand, we have found that it is necessary to familiarize users and health professionals by elucidating them about the efficacy, quality and similarities of generics compared to the brand-name medicines to improve the former prescription and reinforce the right of option at the time of purchase. With this, we conclude that the essential measures to promote generics have already been taken. It is now compulsory to reinforce them and to monitor their outcomes by taking additional initiatives to achieve the objectives for which they were created. From the above, we argue, as recommendation, that incentives based on payments to pharmacies should be adjusted to increase the efficiency of the substitution process. In addition, pharmacies may be allowed to perform some health services and activities of counselling, health promotion, and disease prevention through a contract with the NHS for specific cases of users with needs and whose primary health services are unable to respond. Additionally, we suggest that the price rule for generics should be revised so that pharmacies are not financially penalized for dispensing them. Finally, we also suggest a review of the regulatory framework so that concerns about the safety and efficacy of generic medicines are overcome. The future prospect foresees that Portugal will further increase the market share of the generic, achieving additional satisfactory results and contributing certainly to the sustainability of the NHS and to the reduction of out-of-pocket costs, keeping the same effectiveness and quality of brand-name medicines. Declaration of Competing Interest None. Acknowledgements The second author gratefully acknowledges the generous financial support of the project ‘hSNS: Portuguese public hospital performance assessment using a multi-criteria decision analysis framework’ (PTDC/EGE-OGE/30546/2017), funded by the Portuguese Foundation for Science and Technology (FCT, from the Portuguese abbreviation of Fundac¸ão para a Ciência e a Tecnologia). References [1] Shah U. Regulatory strategies and lessons in the development of biosimilars. In: Wang W, Singh M, editors. Biological drug products: development and strategies. Nova Jersey: John Wiley & Sons; 2014. p. 367–410. [2] Nardi R, Masina M, Cioni G, Leandri P, Zuccheri P. Generic equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world. Italian Journal of Medicine 2014;8(2):88–98. [3] Bate R, Jin G, Mathur A. Does price reveal poor-quality drugs? Evidence from 17 countries. Journal of Health Economics 2011;30(6):1150–63. [4] Xanthopoulou SS, Katsaliaki K. Policies and perceptions on generic drugs: the case of Greece. Health Services Management Research 2018, http://dx.doi.org/ 10.1177/0951484817752630. [5] OECD. Share of generic market for pharmaceuticals. In: Health at a glance: Europe 2016: state of health in the EU cycle. Paris: OECD Publishing; 2016, http://dx.doi.org/10.1787/health glance eur-2016-64-en. [6] Coelho S. Percepc¸ão e comportamento dos consumidores portugueses relativamente aos medicamentos genéricos [Perception and behavior of Portuguese consumers regarding generic medicines]. Lisboa: Instituto Universitário; 2010. [7] Nunes AM, Ferreira DC. Reforms in the Portuguese health care sector: challenges and proposals. The International Journal of Health Planning and Management 2018;34(1):e21–33.
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Please cite this article in press as: Nunes AM, et al. The Portuguese generic medicines market: What’s next? Health Policy (2020), https://doi.org/10.1016/j.healthpol.2020.02.014