The pharmaceutical industry is a strategic sector in Spain, owing not only to the nature of its activity but to its invaluable economic contribution. It is particularly relevant considering its heavy investment in R&D.
The pharmaceutical sector, which has been directly affected by the covid-19 pandemic, is (and will continue to be) at the forefront of discussions regarding R&D budgets and priorities, patent protection and cost-reduction measures, among others. Almost certainly, cost-containment measures will continue to play a prominent role in the following years, with a special focus on the authorities fostering generics and biosimilars.
This chapter provides an overview of the current situation of the pharmaceutical sector in Spain, paying particular attention to the most recent developments from a regulatory, intellectual property and antitrust perspective. In most cases, both the regulations (and guidance and interpretation documents) issued by European Union (EU) institutions and Spain's own state and regional regulations, with their peculiarities, are relevant for these purposes.
II LEGISLATIVE AND REGULATORY FRAMEWORK
i Pharmaceutical regulation
The main piece of legislation governing medical products in Spain is the Royal Legislative Decree 1/2015, approving the revised text of the law on guarantees and the rational use of medicines and medical devices (the Guarantees Law). The Guarantees Law sets out the general principles applicable to the authorisation, manufacturing, labelling, distribution, pharmacovigilance, promotion, dispensation, pricing and reimbursement of medicines for human and veterinary use (including generics and biosimilars), and medical devices.
The Guarantees Law has been amended several times since its enactment, notably during the previous financial crisis to incorporate several cost-cutting and savings measures, and most recently during the covid-19 pandemic.2
The general principles laid down by the Guarantees Law are further detailed by specific regulations depending on the type of medicinal product and its life cycle, from the most basic clinical development to its placing on the market, prescription, dispensation and use.3
Public purchasing of pharmaceuticals is governed by Law 9/2017, on contracts with the public sector (the Public Procurement Law).
The Spanish Medicinal Products and Medical Devices Agency (AEMPS) is the main body responsible for all technical and quality aspects of medical products, while economic aspects (particularly pricing and reimbursement) are dealt with by the General Directorate for the Common Portfolio of National Health System and Pharmacy Services, both part of the Ministry of Health. In addition, the 17 regional governments and other public contracting authorities (including public hospitals) are also competent to negotiate and reach specific pricing agreements with drug marketers, subject to the provisions of Public Procurement Law.
Among other initiatives designed to encourage innovation in the pharmaceutical sector, a prominent role is played by the 'Plan Profarma'. The main objective is to boost competitiveness within the pharmaceutical industry in Spain through modernising the sector and furthering investment in new industrial plants and new technologies for production, and fostering research, development and innovation.4
Pharmaceutical companies operating in Spain that supply its pharmaceutical products (or medical devices) to the Spanish National Health System (SNS) are required to make a contribution to the SNS, calculated on the basis of the volume of sales to the SNS. By participating in the Plan Profarma, they may benefit of certain reductions (up to 35 per cent), according to a varying scale depending on their valuation within the Plan Profarma.
The legal criteria for the inclusion of a medicine in the public reimbursement system and the setting of its price also mention (among many other factors) the medicine's degree of innovation, but in practice it is usually only considered to be relevant as regards real 'blockbusters', as opposed to, for instance, improvements or follow-on innovations.
Finally, the Spanish Ministry of Health has recently published5 a price protection scheme for orphan medicines meeting some requirements. In particular, the scheme foresees the exclusion of those orphan medicines from the reference price system. This is a very recent decision whose interpretation and effects have yet to be assessed.
ii Competition regulation
In the field of competition, the legal framework is two-fold, insofar as both Spanish and EU rules can concurrently apply to potentially anticompetitive practices and mergers and (one or the other depending on which set of thresholds is met) to acquisitions having a potential effect in Spain. The main applicable Spanish competition provisions (including merger control) are set forth in Law 15/2007 on the Defence of Competition (LDC), which is implemented essentially by means of the Regulations on the Defence of Competition approved by Royal Decree 261/2008 (RDC).
Leaving aside rules governing state intervention in companies, the main applicable EU competition rules are Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU),6 which ban, respectively, anticompetitive agreements between companies and abuse of dominance. These primary rules are supplemented by secondary law in the form of parliament and council legislation, as well as European Commission regulations and guidelines. Council Regulation (EC) No. 139/2004 on the control of concentrations between undertakings (Regulation 139/2004)7 sets up the EU merger control regime.
EU and Spanish competition rules fully apply to the pharmaceutical sector to the extent that it constitutes an economic activity. Nonetheless, the Court of Justice of the European Union (CJEU) has ruled, in a case concerning the Spanish national health system, that certain activities carried out by the state in the context of free universal healthcare services that are financed through social security contributions and other state funding do not qualify as economic activities for the purposes of applying competition rules.8
iii Patent and exclusivity regulation
Both Spanish and European patents (designating Spain) coexist in the Spanish patent arena.
Spanish patents are governed by Law 24/2015, on patents and utility models (the Spanish Patents Law). In line with the requirements of the Agreement on Trade-related Aspects of Intellectual Property Rights, Spanish patents last 20 years as from the date of the application.
Spain has been party to the European Patent Convention since 10 July 1986. In line with its Article 65 of the Convention, the effectiveness of European patents in Spain is subject to a further requirement (currently foreseen in Article 155.2 of the Spanish Patents Law). In particular, the filing with the Spanish Patents Office of the translation into Spanish of the relevant patent pamphlet within a three-month period as of the date when the granting was published in the European Patent Gazette.
Supplementary protection certificates (SPCs) for medicinal products are granted by the Spanish Patents Office under EU Regulation No. 469/2009.
The enforcement of Spanish patents, European patents designating Spain and SPCs are governed by both the Spanish Patents Law (with regard to specific patent issues, such as time periods, specific remedies, damages, amendments of claims during the proceedings and standing) and Law 1/2000 on Civil Procedure (for broader procedural matters, as evidence, hearings and appeals).
In addition to the protection granted by patent legislation, the Guarantees Law grants the originator eight years of data exclusivity (during which no application for marketing authorisation of a generic or biosimilar can be sought) and two or three additional years of market protection (as generic drugs cannot be commercialised until 10 years after the date the initial authorisation of the reference medicinal product is granted, or 11 years if a new indication is approved during the first eight years).
Finally, in connection with orphan medicines, Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 establishes a 10-year market-exclusivity period during which no application for a marketing authorisation can be accepted for the same therapeutic indication and in respect of a similar medicinal product. This market exclusivity may be extended in the case of completion of a paediatric investigation plan. In addition to this market protection, the exclusion of orphan medicines from the reference price system must also be taken into account (see Section II.i).
III NEW DRUGS AND BIOLOGICS – APPROVAL, INCENTIVES AND RIGHTS
i Drugs in general
To be placed on the Spanish market, drugs are required to have obtained a prior marketing authorisation from the AEMPS, under the national, mutual recognition or decentralised procedures (or from the European Medicines Agency (EMA), under the centralised procedure), and be registered with the AEMPS's medicines registry.
The national authorisation procedure is regulated by Royal Decree 1345/2007. The authorisation process, following the principles established at the EU level, requires the submission of a detailed application9 that covers all aspects of the medicine, the results of preclinical, clinical and pharmaceutical investigations, and relevant expert reports. The documentation is assessed by the AEMPS, which may request additional information. The assessment of the positive therapeutic effects of the medicinal product will be considered in relation to any risk related to the quality, safety and efficacy of the medicinal product for the patient's health or public health, under a benefit-risk balance approach. The AEMPS then issues a reasoned report, which, if unfavourable, is sent to the applicant before a decision is taken.
In accordance with EU law, as implemented in Spain, the decision of the AEMPS must be issued within 210 calendar days following the submission of a valid application. This term can be extended for three months (or exceptionally six months) if the applicant is requested to provide additional documentation. The authorisation will be valid for five years and may be extended for an indefinite period subject to the risk-benefit ratio being reassessed.
Once authorised, the authorities will need to be notified before a medicine can be placed on the market for the first time. If, within three years after the authorisation is granted, the marketing authorisation holder does not actually place the product on the market or if, after it has been authorised, registered and marketed, it is no longer actually present on the market for three consecutive years, the authorisation for a medicinal product will be deemed to have expired. This 'sunset clause' does not apply, however, when health-related reasons so require, in which case the AEMPS will maintain the validity of the authorisation and may require the effective marketing of the product.
Under certain circumstances, the Spanish regulations also include exceptions to the above-mentioned procedure. In particular, unauthorised medicines can be supplied in special situations (e.g., compassionate use or foreign medicines use). These authorisations can be granted on a named-patient basis or under a general protocol applicable to a category of patients.
Pricing and reimbursement
In addition, before marketing a prescription medicine, the pharmaceutical company must submit it to the national health authorities so that they decide on its inclusion in the reimbursed medicines system. The process to obtain a resolution for pricing and reimbursement is taken at a state level (the Ministry of Health).
The inclusion of a medicinal product in the reimbursement system by the SNS is made possible 'through a selective and discriminatory financing system' that takes into account general, objective and published criteria. Specifically, the following criteria are considered for the purposes of reimbursement decisions:
- severity, duration and effects of the various pathologies for which the medicine is prescribed;
- specific needs of certain patient groups;
- therapeutic and social usefulness and the incremental clinical benefit of the medicine, taking into account its cost-effectiveness;
- rationalisation of public expenditure on medicinal products and the budgetary impact the medicine's inclusion will have on the SNS;
- existence of medicines or other therapeutic alternatives for the same diseases with a lower price or lower treatment cost; and
- degree of innovation of the medicine.
Further, pharmacoeconomic aspects of the product are considered besides the relevant cost-effectiveness and budgetary impact analysis, such as its contribution to the sustainability of the SNS if, for the same result, its contribution to the national gross domestic product is positive.10
Further, most of the regional health authorities perform their own – sometimes informal – cost-benefit assessment prior to allowing the use of new medicines. These factors continue to significantly delay the launch of innovative medicines.
A polemic issue that has raised a deep debate in Spain refers to the transparency and publicity of the procedure for setting the prices and reimbursement conditions of medicines.11
Finally, even though the existing regulation12 is not crystal-clear in this respect, in practice, the health authorities expect medicines to refrain from being marketed and promoted until all the relevant pricing and reimbursement formalities have been completed; this restriction also derives from the Spanish Code of Ethics of the Pharmaceutical Industry. However, these restrictions are currently under review; certain regions already take a more flexible approach towards promotion and there may be options, to be explored on a case-by-case basis, to launch a medicine on the private market while a decision on reimbursement is pending.
ii Generic and follow-on pharmaceuticals
Simplified procedures are in place under the Spanish legislation implementing EU Directive 2001/83/EC for: generics of medicines that have been authorised in other jurisdictions for at least eight years (even if not authorised in Spain); and active principles that are regarded as having had a 'well-established use' in the EU for 10 years and are known to be effective and safe.
The Guarantees Law sets out a simplified procedure for granting marketing authorisations for generic drugs. In particular, there is no obligation to provide the results of the required preclinical and clinical trials if it is proven that the medicinal product is a generic of a reference medicinal product13 that is or has been authorised for a minimum of eight years in any EU Member State, or by the EMA, even if the reference medicinal product is not authorised in Spain.
However, generic drugs cannot be commercialised until 10 years after the date the initial authorisation of the reference medicinal product is granted, or 11 years if a new indication is approved during the first eight years.
Generics benefit from the 'Bolar exemption' that promotes low-cost generic copies of original medicinal products (see Section IV.i).
iii Biologics and biosimilars
Under Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing the EMA, certain biological products, such as advanced therapy products, can only be authorised by the EMA under the centralised procedure. Biosimilars' authorisation is therefore carried out through a centralised procedure based on clinical, non-clinical and quality studies. These studies allow the extrapolation of indications, frequently, without carrying out additional analyses.
The simplified procedure used for the approval of generic drugs, as mentioned in Section III.ii, can be followed for a biological product that is similar to a previously authorised biological product (as a reference product). However, where a biological medicinal product that is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing, in particular, to differences relating to raw materials or differences in manufacturing processes of the similar and the reference biological medicinal product, the results of preclinical tests or clinical trials relating to these conditions must be provided.14
Biosimilars also benefit from the application of the Bolar exemption (see Section IV.i).
There is some controversy regarding the possibility of 'substituting' biological medicines for their biosimilars at the hospital level.15 The Order of the Spanish Ministry of Health SCO/2874/200716 states that, under Article 89.4 of the Guarantees Law, biological medicinal products may not be substituted at the time of dispensing without the express permission of the prescribing physician. The issue at stake here is whether this regulatory provision exclusively applies to the dispensing in street pharmacies, or if it also affects hospital pharmacy services. After some hesitation, the AEMPS seems to support the later view.17 However, future legislative developments or interpretation changes on this issue are not to be ruled out.
In April 2019, the Permanent Pharmacy Commission of the SNS Interterritorial Council approved a proposal for an action plan to promote the use of biosimilar and generic medicines.18 This proposal incorporated a number of initiatives to foster the use of biosimilars and generics, sometimes allowing for positive discrimination in favour of these medicines (such as prioritising the initiation of the dossiers for inclusion of generics and biosimilars in the pharmaceutical reimbursement system, adopting the prescription by active ingredient, introducing a claw-back mechanism for pharmacy discounts, etc.). Implementation of this action plan, should it be the case, would require the relevant legislative amendments. While this proposal has been welcome by operators in the generic and biosimilar sector, it has been heavily criticised by biological companies and, in general, full-fledge innovators.
This plan was closely analysed by the Spanish Markets and Competition National Commission (CNMC).19 While the CNMC issued some recommendations and suggestions to improve this plan, it generally shared its orientation and ultimate objectives, reiterating that it is necessary and desirable to promote the penetration and widespread of generic and biosimilar medicines in the Spanish market.
The plan, which was further updated in September 2019 to try to encompass the suggestions made by the CNMC, clearly shows that the Spanish authorities intend to encourage the development, authorisation, prescription and use of generic and biosimilar medicines to seek a better efficiency in health economic resources. It remains to be seen whether this proposal will be approved or whether it will undergo further changes as many operators in this sector claim.
Otherwise, biological medicines in Spain are generally subject to the same general requirements for manufacturing, advertising and sale as other medicines.
IV PATENT LINKAGE
Under Spanish law, the existence of one or more patents (or SPCs) that can be potentially infringed is not taken into account when granting the marketing authorisation for a generic or biosimilar product (or during its inclusion in the SNS). The Guarantees Law and Spanish courts have clarified that these decisions are taken without prejudice to the rights granted by the industrial property legislation.
However, as will be seen, this does not entail that the patent (or SPC) holder cannot take any action during or after the administrative proceedings, especially in situations where there is a risk of imminent commercialisation by the manufacturer of generics or biosimilars. These measures normally focus on avoiding commercialisation before the expiry of the patent (or SPC) as well as the inclusion of the original medicine in a price reference group or homogenous group, or both, (which would lead to a reduction in its price).
i Granting the marketing authorisation to the generic or biosimilar product
Article 61.1 of the Spanish Patents Law contains the 'Bolar provision', which states that the rights granted by a patent (or SPC) do not apply to studies and trials aimed at obtaining the authorisation for medicines (in Spain or abroad), including preparing, obtaining and using the active ingredient for this purposes. Therefore, none of these activities can be considered to infringe a patent (or SPC) provided that they are strictly aimed at obtaining the relevant marketing authorisation.
ii Inclusion of a generic or biosimilar in the reimbursement system of the SNS
Since the enactment of Royal Decree Royal Decree 177/2014, the inclusion of medicines in the reimbursement system of the SNS is a two-step procedure. As explained above, once the medicine is authorised, pricing and reimbursement proceedings start. At first step, the Ministry of Health decides on its inclusion in the reimbursed medicines system. However this inclusion will not be effective (and the medicine included in the catalogue of medicines) until a further step is taken by the marketing authorisation holder. In particular, the filing of a communication on its decision to commercialise (and intended date commercialisation) the medicine at hand to the Ministry of Health (more specifically, to the General Directorate for the Common Portfolio of National Health System and Pharmacy Services).
The actual date of effective inclusion depends on the date the effective date of commercialisation being communicated.20
Patent actions during the non-effective inclusion period
For patent actions to be granted, patentees must evidence, at least, a risk of imminent infringement.
According to Spanish case law, the non-effective inclusion of a generic or biosimilar in the SNS does not entail per se an infringement of the relevant patent (or SPC).
However, during this period, originators should closely follow the factual situation to be in a position to file action when possible. For these purposes, patentees normally send warning letters to the manufacturers of generics or biosimilars informing them of the existence of the relevant patent or SPC (and, in light of the response, infer its intention to commercialise the generic or biosimilar product before the expiration of the patent or SPC).21 Likewise, originators usually request the General Directorate for the Common Portfolio of National Health System and Pharmacy Services to keep them updated on the status of reimbursement proceedings of the generic or biosimilar.
In any event, under certain circumstances, there could be a risk of imminent infringement even before the date of effective inclusion in the SNS. Especially, when the manufacturer of generics or biosimilars is in a position to commercialise them considerably before the date of expiry of the relevant patent (or SPC). It may occur in situations where the marketing authorisation is granted (or the financial information to establish the price is provided to the authorities) more than three years before the patent expires (due to the impact of the sunset clause explained in Section III).
This evidence can be completed by the responses by the manufacturers of the generic or biosimilar to the originator's warning letters referred to above (denying or not the commercialisation of the product before the patent or SPC expires). In this regard, case-law objective factors would prevail over the subjective declarations of the generic or biosimilar companies.
Patent actions as of effective inclusion
After the effective inclusion in the SNS, the commercialisation of the generic or biosimilar is imminent and, therefore, as a general rule, there is an imminent risk of infringement.
iii Preliminary or final injunctions
Originators can request both preliminary and final injunctions. In particular, preliminary injunctions can be requested before or together with the claim; and with or without hearing the defendant (cases where the originator must bear in mind the impact of the 'protective letters'). Requirements for the granting differ depending on the type of preliminary injunction.
Several types of preliminary or final injunctions have been granted by Spanish courts, such as: the prohibition (or cease) of the commercialisation of the generic or biosimilar medicine; restrictions to the transfer of the marketing authorisation (and the corresponding notification to the AEMPS); and notification to the General Directorate for Pharmacy Medical Devices that the generic or biosimilar product cannot be commercialised or prescribed (and its exclusion from the Spanish Prescription Nomenclator). In connection with second-use patents, the communication by the manufacturer of generics or biosimilars to the practitioners that the product cannot be prescribed or provided for the specific protected use as well as the corresponding indication in the Spanish Prescription Nomenclator (to avoid generics or biosimilar being prescribed) can be requested.22
V COMPETITION ENFORCERS
The CNMC is the independent administrative agency responsible for applying Articles 101 and 102 of the TFEU, the LDC, the RDC and other applicable competition rules in Spain. Certain regional governments have their own competition authorities, which may intervene in relation to anticompetitive practices having an effect only in their territories but lack merger control competence. The CNMC's and regional authorities' decisions are subject to appeal before, respectively, the National Court of Appeal and the corresponding regional high court. Eventually, they can also be appealed to the Supreme Court.
Additionally, the European Commission (the Commission) is competent to apply EU competition rules in all Member States. It has exclusive jurisdiction under merger control rules where the concentration is deemed to have an 'EU dimension' within the meaning of Regulation 139/2004. Contrarily, competence for applying Articles 101 and 102 of the TFEU to practices 'affecting trade between Member States' is agreed upon with national competition authorities through coordination within the European Competition Network. The Commission's decisions are subject to appeal before the General Court of the EU, the rulings of which may be challenged before the Court of Justice.
The CNMC is composed of an investigative body (the Directorate for Competition), which is functionally independent from the decision-making body (the Competition Chamber of the Board). Regional authorities mirror this structure but some of them feature only an investigative body and rely on the Board of the CNMC for decision-making. The Directorate for Competition brings proceedings on its own motion, at the request of the Board or following a complaint filed by any person. In addition, a leniency programme allows cartel infringers to apply for immunity or reductions in fines in exchange for acknowledgment of liability and information on the infringement, as well as a publicly available whistle-blower tool.
Before proceedings are formally opened, the Directorate for Competition can conduct an informal preliminary inquiry, during which companies' procedural rights are not fully guaranteed. Once the Directorate for Competition considers that there are sufficient signs of an infringement, it may open the formal procedure. Otherwise, it may propose its closure to the Board, which may order that the formal procedure be initiated instead. Following formal opening, the Directorate for Competition must complete its inquiry and submit a draft decision to the Board, and the latter must adopt and notify a decision within 18 months or it will expire.
The CNMC has broad investigative powers to carry out unannounced inspections at companies' premises or employees' domiciles, which allow its officials to enter and seal any facilities (upon prior consent or court order), access, seize, copy and retain any documents in any format, and request and record explanations on facts and documents. It may also send requests for information.
Additionally, the CNMC may impose administrative fines of up to a certain percentage of the infringer's total turnover (not only revenues from the products concerned) in the preceding year to the decision: 1 per cent for minor infringements (mainly procedural breaches), 5 per cent for serious infringements (e.g., abuse of dominance, anticompetitive agreements between non-competitors or gun jumping) or 10 per cent for very serious infringements (e.g., abuse of dominance by current or former monopolies, or anticompetitive agreements between competitors). Time limitation periods are one year for minor infringements, two years for serious infringements and four years for very serious infringements, as from the moment they cease. Following the annulment of its former fining guidelines by the Supreme Court in 2015,23 the CNMC is developing a new methodology that is still rather opaque.
Administrative consequences of competition infringements in Spain may also include fines totalling €60,000 for legal representatives and managers of infringing companies, which have been fairly common since 2016 in cartel cases. Additionally, in several recent decisions,24 the CNMC has availed of the public procurement provision, which allows for debarment of natural or legal persons from public tendering for up to three years in the case of a serious (or very serious) infringement. There is still uncertainty around the direct applicability of the debarment sanction imposed by the CNMC, which has so far referred it to public procurement enforcement bodies to decide on the scope and duration of the prohibition, while declaring leniency beneficiaries exempt.
Regarding private enforcement, Articles 1 and 2 of the LDC entail the nullity of any agreement or conduct in breach thereof, as do Articles 101 and 102 of the TFEU, and provide grounds for a claim for damages before national commercial courts. Actions for damages have been boosted in Spain by the 2017 amendments to the LDC and Law 1/2000 on Civil Procedure, which implemented Directive 2014/104/EU of the European Parliament and of the Council of 26 November 2014 on certain rules governing actions for damages under national law for infringements of the EU's and Member States' competition law provisions.25
Concerning intervention prospects, the CNMC has endorsed the 2019 report on competition enforcement in the pharmaceutical sector drafted by the Commission in the context of the ECN.26 Since then, it carried out announced inspections at the premises of at least three laboratories in 2019, according to public press releases. Moreover, in line with the Commission's resolution to curb exploitative price abuses by laboratories, the CNMC has proven ready to inquire into excessive pricing by bringing proceedings against Aspen, which were eventually closed when the Commission took over.27 This trend is expected to grow in the aftermath of the covid-19 pandemic as profiteering practices come under fire.
VI MERGER CONTROL
Under Spanish merger control rules, any change in the control structure by means of the merger of several companies, the acquisition of control by one or several companies over one or several companies, or the creation of a fully functional joint venture is an economic concentration.28 If an economic concentration having an effect in Spain does not meet the thresholds to be considered of an 'EU dimension', it may be subject to notification to the CNMC,29 in which case its implementation must be suspended until clearance.30 Referral mechanisms between the Commission and national competition authorities are also in place.
Prior to formal submission, customary informal contacts are held with the CNMC to ensure filing is completed and potential concerns clarified. Pre-filing contacts are not subject to a deadline, but their duration may range from around two to four weeks in straightforward cases to around four to five months if there are significant activity overlaps or important presence in vertically related markets. After formal submission, phase 1 starts, and a decision must be issued within one month. If serious concerns are raised, phase 2 is opened, which consists of an in-depth analysis for up to two additional months.31 If no decision is issued within these deadlines, the concentration is deemed authorised. Intervention by the government in prohibition or conditional approval phase 2 cases is possible under certain circumstances but are very exceptional in practice.
The legal test for a concentration to be banned under Spanish rules (in the same way as under EU rules) is the 'significant impediment to effective competition' caused by either non-coordinated effects (i.e., post-merger reduction of the competitive pressure on either the merged entity or on the other remaining players in the market), or coordinated effects (i.e., increased likelihood of collusion among competitors or easier or more effective pre-existing collusion). To solve concerns raised by the CNMC, the notifying parties may offer their commitment to implementing remedies as a condition for authorisation. Structural remedies (essentially divestments) are usually preferable but behavioural remedies might be sufficient in the absence of significant overlaps.
Recently, the CNMC has had the opportunity to look into the marketing of pharmaceuticals and defined local markets for the wholesale distribution of medicines and health products to pharmacies encompassing areas of 120 to 150-minute drive radii (albeit analysing in practice the provinces in which the combined market shares exceeded 25 per cent and bordering provinces).32
Regarding finished doses, the CNMC uses the Anatomical Therapeutic Chemical (ATC) Classification System of the World Health Organisation as a reference for market definition in line with the CJEU's case law, which sets ATC level 3 (i.e., therapeutic and pharmacological subgroups) as a departure point for selecting candidate products33 (see below). In a recent case, the CNMC has defined the market as narrowly as at ATC level 5 (i.e,. molecular composition) for two orphan drugs with no close substitutes (of a national scope), as well as an upstream (at least European) market for the licensing of rights in relation to them, while recalling that separate markets are to be defined for prescription and over-the-counter products.34
Previously, the CNMC had adopted the same approach in defining a national market for over-the-counter antidiarrhoeal drugs (while leaving open whether ATC levels 2 or 3 were relevant) and a separate European market for their active pharmaceutical ingredients.35 In this case, the termination of an agreement whereby a pharmaceutical company granted to another the exclusive right to use a brand for the marketing of certain antidiarrhoeal drug in Spain, along with the relevant know-how and the right to obtain the necessary marketing authorisation, was classed as a concentration as it involved the returning of control over the business to the brand owner.
As concerns future trends, 'killer acquisition' concerns over transactions involving pipeline products have come to the forefront of the European merger control debate in the context of a broader discussion about the consideration to be given to innovation. The trend towards a higher degree of factual and economic analysis, which seems to have also reached the CNMC, is anticipated to infuse the aforementioned discussion into Spanish merger control.
VII ANTICOMPETITIVE BEHAVIOUR
Restrictions on parallel imports under Articles 1 of the LDC and 101 of the TFEU used to take centre stage in Spanish pharmaceutical competition enforcement due to the intervened prices for publicly financed drugs to be dispensed in Spain. After a series of decisions and judgments, this practice was disregarded as not resulting from a 'dual pricing' policy of laboratories but rather from public intervention overriding their commercial freedom.36
More recently, a complaint by the veterinary medicines sectoral association against a number of laboratories was dismissed.37 Allegations centred around the fixing of resale prices charged by retailers authorised to dispense veterinary medicines, their absolute territorial protection, and the request of sensitive information from them were rejected. The reasons were the lack of proof of collusion among laboratories or hard-core vertical restrictions, and the laboratories' individual market share below 30 per cent, which were held by the CNMC to make any potential vertical restraint exempt.
Concerning abuse of a dominant position, the administrative and judicial practice has been brought in line with CJEU's case law as regards the definition of relevant markets for drugs below the ATC level 3 (see Section VI) and the possibility of dominance not being excluded by national health systems' buying power.38 Two earlier precedents saw national markets for finished doses be delimited according to their therapeutic indication (i.e., ATC level 3),39 while the possibility of descending to the mode of action (i.e., ATC level 4) was considered but deemed too narrow.40 Abuse charges were deemed unfounded in both cases, so no in-depth analysis of dominance was carried out.
Furthermore, dominance used to be ruled out in traditional National Court of Appeal's case law because of the intense public intervention and the great bargaining power of the national health system in pharmaceutical markets.41 The Pfizer case marked the turning point as this company was considered dominant in an ATC level 4 market, where its original drug was only rivalled by generics, on the grounds of the exclusivity rights attached for a long period to patent protection.42 Nonetheless, proceedings were closed due to lack of proof of the abusive conduct.
Besides, the recent developments brought about by the CJEU's rulings regarding pay-for-delay and other practices may make the CNMC open to taking a more fact-based stance. Thus, for instance, prescribers and patients' inertia and switching patterns, as well as the companies' own perception of rivalry, may gain a foothold in market definition and dominance appraisal to the detriment of rigid categories based on the objective characteristics of the drugs, in line with cases such as Servier,43 Hoffmann-La Roche44 and Generics.45 The light shed by these judgments may also lay the foundations for more targeted competition enforcement in the pharmaceutical sector. For that matter, the CNMC's action plan for 2020, as adjusted to the covid-19 pandemic, mentions the pharmaceutical sector as the target of a sectoral inquiry, and announces enhanced cooperation with the Spanish national medicines association for the detection of anticompetitive practices.
VIII OUTLOOK AND CONCLUSIONS
The Spanish pharmaceutical sector is mainly shaped by EU regulations, although with certain peculiarities and trends of its own, in particular with regard to the pricing and reimbursement system. In any case, the impact of the covid-19 outbreak in Spain and the most recent developments should be especially taken into consideration. We can expect Spanish authorities, in both the regulatory and competition fields, to continue promoting the use of generics and biosimilars, as one of the measures to contain health expenditures, although, hopefully, also allowing for a framework where innovation is still encouraged. In any case, under Spanish patent legislation (which can be combined in some cases with regulatory actions), originators will retain useful tools that lead to a good protection to their investments. Also, transparency of public financing and pricing decisions, aiming at ensuring greater efficiency in the distribution of resources, will continue to be a particularly relevant issue.
As regards competition enforcement, the trend towards bolder intervention to curtail abusive commercial practices witnessed in other EU jurisdictions (including the Commission) anticipates action will be taken in relation to excessive pricing, especially in the context of price gouging aiming to profiteer from the covid-19 pandemic. Additionally, recent clarifications in CJEU's pay-for-delay rulings appear to have paved the way for national prosecution of hypothetical strategies aimed at foreclosing generics from the perspective of both anticompetitive agreements and abuse of dominance (the importance of the sector has already been highlighted in the CNMC's 2020 action plan). In any event, a higher degree of sophistication in enforcement and more margin for fact-based and economic-driven analysis is to be expected in line with European developments, which in the field of merger control may translate into innovation theories of harm being the bone of contention.
1 Teresa Paz-Ares, Alfonso Gutiérrez and Ingrid Pi Amorós are partners at Uría Menéndez Abogados, SLP. The authors thank Alejandro Abad, Pablo Solano and Fernando Azcona for their contributions to this chapter.
2 For instance, Article 94.3 of the Guarantees Law was modified to allow the Interministerial Drug Pricing Commission to establish the maximum retail price of medicines, medical devices and other health protection products so as to guarantee citizens' access to these products during the covid-19 outbreak in Spain.
3 These include, among others, Royal Decree 1345/2007 on the procedure for the authorisation, registration and supply conditions of industrially-manufactured medicinal products for human use (Royal Decree 1345/2007); Royal Decree 1015/2009 on the availability of medicines in special situations (Royal Decree 1015/2009); Royal Decree 824/2010 on pharmaceutical laboratories, producers of active ingredients for pharmaceutical use, and the international trade of medicines and investigational medicines; Royal Decree 177/2014 governing the reference price and homogeneous groups system within the national healthcare system and certain information systems concerning reimbursement and pricing of medicines and medical devices; and Royal Decree 477/2014 on the authorisation of non-industrial advanced therapy medicines.
4 The current Plan Profarma (2017–2020) was approved by means of the Resolution of 6 July 2017 of the General Secretary of Industry and the Medium and Small Size Enterprise.
5 Decision dated 3 March 2020 and published 12 June 2020.
6 Official Journal of the European Union C-326, 26.10.2012, p. 1–390 (consolidated version).
7 Official Journal of the European Union L-24, 29.1.2004, p. 1–22.
8 Judgment of the Court of First Instance of 4 March 2003 in case T-319/99 FENIN v. Commission, upheld by Judgment of the Court of Justice of 11 July 2006 in case C-205/03 P FENIN v. Commission.
9 The current fee for the evaluation, authorisation and registration of a new medicinal product for human use is €21,151.22, and €8,603.75 for a new generic medicine. These fees may vary depending on the state's general budget.
10 Once a product is listed for reimbursement, specific prescription, dispensation and financing conditions may be imposed on reimbursed products to ensure the rational use of the medicinal product within the scope of the SNS. Thus, for example, it is not uncommon to find medicines for which reimbursement by the SHS requires that they are dispensed in hospitals, while the summary of product characteristics contains no such dispensation restrictions
11 The Spanish Transparency and Good Governance advisory body (CTBG), and some subsequent court decisions, have been resolving on different matters concerning balance between, on the one hand, the general right of the public to information and transparency, as enshrined in Spanish Law 19/2013 on transparency, access to public information and good governance (and at the EU level, regarding medicinal products, in Directive 89/105/EEC) and, on the other hand, the protection of business and commercial interests of marketing authorisation holders. The Spanish Ministry of Health stands for the need to maintain the confidentiality of information concerning the price of medicines, as it allows 'each country to achieve the best possible price according to its circumstances', claiming that 'if there were no confidentiality at the European level, prices would tend to equalise in a single value that could be relatively low for the richest countries, but too high for those with less economic capacity', which 'could hinder access to patients in those countries with fewer resources' (see CTBG's Resolution 478/2019 of 26 September). However, the CTBG has not always upheld these arguments, ruling in some cases that certain documentation within the administrative files of a medicine's price setting, which is non-confidential or does not affect the economic interests of the marketing authorisation holder, must be provided to the applicants. The debate is open and there are relevant cases pending before the courts.
12 Article 93 of the Guarantees Law.
13 To prove that a medicinal product is a generic of a reference medicinal product, according the definition adopted in Spain following the implementation of Directive 2001/83/EC, the generic medicine must meet the following conditions: it has the same qualitative and quantitative composition of active ingredients; it has the same pharmaceutical form; and its bioequivalence with the reference medicinal product has been proved by bioavailability studies.
14 Article 17.4 Guarantees Law.
15 While some stakeholders (among others, several Spanish Medical Associations and Farmaindustria; see Farmaindustria's Statement of 8 February 2017 on the substitution of biological drugs) advocate that it is not possible to replace a biological medicinal product by its biosimilar at the hospital pharmacy level, as these products hold the condition of 'individualised products' (subject to further monitoring) and substitution can only be decided by the prescribing physician (and not by the hospital pharmacy commission), other relevant actors, including regional health departments, public contracting bodies or scholars, claim that this substitution is perfectly legal, prioritising the ultimate objective of cost-reduction measures.
16 Also the Information Note of the AEMPS of 24 April 2009.
17 According to the information published by the AEMPS on its website on 4 April 2018.
18 Plan de acción para fomentar la utilización de los medicamentos reguladores del mercado en el sistema nacional de salud: medicamentos biosimilares y medicamentos genéricos, Comisión Permanente de Farmacia del Consejo Interterritorial del SNS, 11 April 2019, updated 24 September 2019.
19 INF/CNMC/059/19. Informe sobre el Plan de acción para fomentar la utilización de los medicamentos reguladores del mercado en el sistema nacional de salud: medicamentos biosimilares y medicamentos genéricos, CNMC, 27 June 2019.
20 In particular if the communicated date of effective commercialization is between days 1–15 of the month, effective inclusion in the SNS will take place on day one of the following month; and if the (communicated) date of effective commercialisation is between days 16–31 of the month, effective inclusion in the SNS will take place on day one of the second subsequent month.
21 See, e.g., the Order of the Commercial Court of Barcelona dated 29 December 2009; the Judgment of the Court of Appeal of Barcelona dated 6 November 2010; Judgment of the Barcelona Court of Appeal dated 22 January 2013; Order of the Court of Appeal of Barcelona dated 16 June 2013; and the Order of the Commercial Court of Barcelona dated 30 May 2017.
22 Order of the Court of Appeal of Barcelona dated 5 July 2016.
23 Judgment of the Supreme Court of 29 January 2015 in appeal 2872/2013.
24 Decisions of the CNMC of 14 March 2019 in case S/DC/0598/2016 Electrificación y. Electromecánicas Ferroviarias, of 1 October 2019 in case S/DC/0612/17 Montaje y. Mantenimiento Industrial, and of 13 February 2020 in case S/DC/9626/18 Radares Meteorológicos.
25 Official Journal of the European Union L-349, 5.12.2014, p. 1–19.
26 Report from the commission to the Council and the European parliament 'Competition enforcement in the pharmaceutical sector (2009-2017). European competition authorities working together for affordable and innovative medicines' (COM(2019) 17 final).
27 Decision of the CNMC of 20 July 2017 in case S/DC/0601/16 Laboratorios Aspen.
28 'Control' means the possibility of exerting decisive influence, regardless of the legal grounds, on the market behaviour of a business with current market presence, or that can be reasonably expected to develop market presence in a reasonably timely manner, and to which a market turnover can be clearly attributed. The Commission has considered that this is the case of developing, manufacturing and marketing rights in a pipeline drug that is already in phase III (confirmatory) trials, along with related tangible assets, administrative approvals, clinical trial data and supply contracts, in the decision of the Commission of 18 December 2015 in case M.7872 Novartis/GSK (ofatumumab autoimmune indications).
29 There are two alternative notification thresholds in Spain: a market share is acquired or increased up to or over 30 per cent (50 per cent if the target's turnover in the preceding financial year did not exceed €10 million) in any product market either in Spain or in a geographic market defined within it; or both parties' combined turnover in Spain in the preceding financial year exceeded €240 million, and each of their turnover in Spain exceeded €60 million.
30 Failure to notify a concentration subject to review by the CNMC, and its execution before authorisation (i.e., gun jumping) are two separate serious infringements entailing fines of up to 5 per cent of the company's total turnover during the preceding financial year.
31 In practice, however, proceedings extend significantly beyond the two-month deadline, since requests for information to the merging parties or to third parties automatically stop the clock. The offering of remedies entails an extension of 10 additional days in phase 1 and 15 in phase 2.
32 Decisions of the CNMC of 19 July 2018 in cases C/0959/18 Bidafarma/Socofasa and C/0958/18 Bidafarma/Zacofarma, and of 21 November 2019 in case C-1054/19 Cofares/Cofarta. In the latter, the CNMC did not authorise as ancillary to the acquisition of a distributor by a cooperative the pre-existing agreement between them, which was subject to tactic extensions for an indefinite duration, whereby the target would integrate its orders with those of the acquiring cooperative, and which contained an exclusivity purchasing commitment.
33 Judgment of the General Court of 1 July 2010 in case T-321/05 AstraZeneca v. Commission.
34 Decision of the CNMC of 2 March 2018 in case C-0925/18 Recordati/Mylan.
35 Decision of the CNMC of 14 March 2017 in case C-0832/17 Janssen/Esteve (Assets).
36 Decisions of the former CNC of 29 May 2009 in case 2623/05 Pfizer/Cofares, and of the CNMC of 19 January 2017 in case S/DC/0546/15 Pfizer/Cofares, and of 30 August 2018 in case S/DC/0608/17 EAEPC v. Laboratorios Farmacéuticos, and corresponding appeals (still pending before the National Court of Appeal as at the date of this contribution).
37 Decision of the CNMC of 7 October 2018 in case S/DC/0539/14 Medicamentos veterinarios.
38 Judgments of the General Court of 1 July 2010 in case T-321/05 AstraZenecav v. Commission (upheld by Judgment of the Court of Justice of 6 December 2012 in case C-457/10 P AstraZeneca v. Commission) and of 12 December 2018 in case T-691/14 Servier and others v. Commission.
39 Decision of the CNC of 9 June 2010 in case S/0176/09 Sedifa y. Grufarma.
40 Decision of the CNC of 25 April 2011 in case S/0228/10 Novartis.
41 Judgments by the National Court of Appeals of 14 February 2005 in appeal 79/2002, of 17 July 2006 in appeal 179/2004, and of 10 May 2007 in appeal 56/2004. Also, decision by the CNC of 16 January 2008 Preparados Farmacéuticos.
42 Decision of the CNC of 13 February 2014 in case S/0441/12 Pfizer Health AB y. Pfizer SLU.
43 Judgment of the General Court of 12 December 2018 in case T-691/14 Servier and others v. Commission.
44 Judgment of the Court of Justice of 30 January 2020 in case C-307/18 Generics (UK) Ltd and others v. CMA.
45 Judgment of the Court of Justice of 23 January 2018 in case C-179/16 F. Hoffmann-La Roche Ltd and Others v. AGCM.