The EU as a Political Determinant of Global Health: The Case of Research and Development Incentives for Orphan Medicines and Biotechnology

Abstract

Context: The European Union (EU) governs global health through its constituent laws, institutions, actors, and policies. However, it is unclear whether or how these political factors interact to position the EU as a political determinant of global health.

Methods: The authors conduct a case study of the political factors influencing the adoption of the EU's Biotechnology Directive 98/44/EC and Orphan Medicines Regulation 141/2000.

Findings: The European Commission (EC) generally framed both of its proposals around economical and biomedical paradigms aligned with the needs of the EU's industry and patients, whereas the European Parliament (EP) contested some of these frames and proposed amendments supporting global access to medical products. The political factors influencing the adoption (in the Biotechnology Directive) or rejection (in the Orphan Regulation) of the EP's amendments include the complementarity between the EP and EC proposals, the EP's power in the intra- and interinstitutional negotiating process, the existence and support of civil society, and the alignment with member state priorities in the Council.

Conclusions: In the late 1990s, the EU was an internally fragmented and politicized player concerning global health matters. These political factors should be considered for a coherent post-2022 EU strategy on global health.

In the face of increasing health inequalities between and within countries, the mounting (political) power of (transnational) health-related industries, growing nationalistic sentiments, and strained public health budgets, ever more attention is paid to the political determinants of health (PDoH) (Coggon 2020; Kittelsen, Fukuda-Parr, and Storeng 2019; Ottersen et al. 2014). PDoH have been described by Kickbusch (2015) as the “different power constellations, institutions, processes, interests, and ideological positions [that] affect health within different political systems and cultures and at different levels of governance.” To date, most literature focuses on global or national PDoH, with growing attention to the European Union (EU) as a PDoH within its borders (Godziewski 2020). The present article looks beyond the EU's internal impacts on human health to explore the political factors that could make the EU's internal legislation and regulation a political determinant of global health.

To explore this question, we must first understand how the EU's political architecture exemplifies the components of a PDoH, which include voting/voters, governance, and policies (Velasquez, Figueroa, and Dawes 2022). This article focuses on the last two components.

The EU's governance for global health has both external and internal dimensions. The EU's explicit external role in governance for global health is shaped by its formal competences, which are rooted in its scope for action on development cooperation (article 208 Treaty on the Functioning of the European Union [TFEU]) and external trade (article 207 TFEU) and are complemented by the EU's duty to protect human health “in the definition and implementation of all Union policies and activities” (articles 9 and 168 TFEU). The EU's governance for global health can also draw on “informal practices,” such as its material power, in the absence of formal competences in global health, as observed in relation to COVID-19 vaccines (Svendsen 2021). Externally, the EU has exclusive competence to represent its member states in trade negotiations such as those at the World Trade Organization (WTO), and it often plays a leading role in the negotiation of new global health laws at the World Health Organization (WHO) (Ruiz Cairo 2020).

Internally, the EU governs for global health from within its public health (articles 9 and 168 TFEU) and internal market (article 114 TFEU) competences, using its autonomous legal order and institutions to affect global health issues. For example, by regulating the internal market, the EU can establish health norms, standards, and decisions that inspire similar global standards (e.g., Guidelines on Good Clinical Practice) and medicine licensing decisions by regulators in third countries (EC 1997b: 23; Perehudoff et al. 2021). The EU can also create incentives for private industry or even mobilize its resources to invest in the research and development (R&D) of health-related goods for European citizens and potentially for patients beyond the EU (Rollet 2022). This article focuses on the internal dimension of the EU's governance for global health.

The last component of a PDoH—EU policy—can prioritize or marginalize global health issues. The EU's early (internal) public health and external development policies emerged from different departments of the European Commission (EC),¹ the so-called directorate-generals (DGs). These DGs and their content respectively reflected a fragmented approach to global health (EC 1993, 2000, 2002). This gap was partially bridged in 2010 by the EC communication on the EU's role in global health and the Global Health Council conclusions (Emmerling and Rys 2016: 81). The EC prioritized greater policy coherence and aimed to coordinate research on global health more effectively by identifying global research priorities and promoting “effective and fair financing of research that benefits the health of all people” (EC 2010: 9). In response, the Council of the EU echoed the EC's call for effective and fair R&D financing for all by ensuring “that innovations and interventions produce products and services that are accessible and affordable” (Council 2010: 5). Following a decade of policy stagnation, the EC's 2022 Global Health Strategy ushered in the EU's renewed aspiration to be a global health leader, backed by 20 global health principles and a commitment to policy coherence. Among those principles is the aim to boost research on technologies needed for global health (principle 5) (EC 2022).

The EU represents a substantial normative market and regulatory power in the world (Bradford 2021; Damro 2012; Manners 2002). Through its legislation, institutions, actors, and policies, the EU and its internal politics have the potential to influence global health policy and practice, such as whether the EU adopts R&D incentives for health-related technologies, and to what extent they could benefit people in low- and middle-income countries. Therefore, this article asks the question: which political factors influence the production of the EU's internal market legislation establishing incentives for biomedical R&D? This article is based on the assertion that the EU's internal market action on biomedical R&D (specifically directive 98/44/EC on the legal protection of biotechnological inventions (hereinafter: Biotechnology Directive) and regulation 141/2000 on orphan medicinal products (hereinafter: Orphan Regulation) could contribute to the development and dissemination of innovative medicines and health-related technologies needed in developing countries (Perehudoff et al. 2021).

Global Health and R&D for Health-Related Technologies

The dearth of R&D and access to innovative medicines and biotechnologies for preventing, treating, and surveilling diseases worldwide, and specifically in developing countries, increasingly threatens human health and well-being, sustainable development, and economic and health systems. These issues arise in part from the market-driven model of biomedical R&D, which incentivizes new health products for “profitable” diseases or populations and neglects the needs of “patients [who] are either too few or too poor,” referring to orphan conditions or diseases widespread in developing countries (EC 2010: 5).

Several policy interventions have attempted to address this dearth of biomedical R&D and barriers to access to medicines. One intervention is to offer market exclusivity, whereby the medicine is protected from competition for a period during which similar products for the same indication cannot be marketed. The EU adopted this policy measure in its Orphan Regulation as an attempt to incentivize medicine developers to test and license (often existing) medicinal products for orphan indications lacking acceptable or effective therapeutic options. The regulation offers 10 years of market exclusivity for medicines designated as orphan products. Such incentives offered on major global markets (i.e., EU, United States) could also result in a potential net benefit for patients and consumers in developing countries who require the same medicines and health technologies (EMA 2013; Villa, Compagni, and Reich 2009). The example of off-patent azidothymidine (AZT) for HIV/AIDS illustrates how a US law offering market exclusivities for products treating rare conditions incentivized a drug company to further develop that product to be the first antiretroviral (Sekalala 2017: 16–17).

Another policy intervention to enhance access to health-related technologies in developing countries is to promote the fair governance of technologies developed using resources from those regions. Many developing countries are rich in biodiversity, making them prime sources of genetic resources and organisms of use or value to humanity (article 2 UN Convention on Biological Diversity [CBD]), that is, by serving as a basis for modern biotechnologies. Important ethical questions arise when (foreign) companies and private parties use Indigenous knowledge to identify, screen, and/or harvest/export these resources from developing countries to further develop, patent, and/or sell them as private property on the global market (Cloatre 2006: 348). This phenomenon, known as “bioprospecting” (Greene 2004: 213), was addressed in the CBD to which the EU and its member states are parties. The CBD promotes “equitable sharing in benefits,” requiring resources derived from developing countries and with Indigenous knowledge that lead to a marketable technology to be protected and the material benefits to be shared with the contributing local communities (article 8[j]). A critical component of sharing benefits is establishing the geographic place of origin of the (genetic) materials on which biotechnologies are based, which makes it possible to identify to whom the benefits are owed. The CBD also requires the private sector to take steps to facilitate access to and transfer of technology for the benefit of governments and the private sector in developing countries (article 16).

In the late 1990s, these concepts were still novel to the EU's approaches to incentivizing biomedical R&D (Cloatre 2006: 346). The place-of-origin requirement was raised by EU legislators in the context of Biotechnology Directive negotiations. The directive sought to harmonize the level of patent protection for biotechnology on the EU's internal market, and in doing so, to promote its functioning and create incentives for biomedical R&D.

Theory

This study applies Rushton and Williams's (2012) framework for analyzing global health policy making to conceptualize the power and authority of political actors and the paradigms and frames they use to explain which political factors influence the production of global health policy (fig. 1).

Rushton and Williams argue that the content of global health policies is shaped by the independent and combined influence of the power and authority of political actors, on one hand, and the paradigms (156) and their framing in political discourse on the other. Underlying the power/authority and the paradigms/framing dimensions is a so-called deep core that structures global health policy making (153). According to Rushton and Williams, “neoliberalism appears to operate as a deep core, in doing so having both direct and indirect effects upon global public policy. It seems to both privilege particular policy preferences and also structures the terrain on which policy debates take place” (165).

Paradigms are the underlying mindsets that “structure how actors view and understand the world, [and] embody taken for granted ideas and assumptions about how the world works” (156). The predominant paradigm(s) or underlying mindset(s) through which an actor views a global health issue influence the extent to which the actor will be persuaded by certain policy choices. Policy choices that are framed or articulated in a manner consistent with the actor's paradigm will, as argued by Campbell (cited in Rushton and Williams 2012: 156) “appear natural and familiar” and are more likely to convince that actor of the salience of a particular problem and a related policy solution (155).

In the ensuing policy debate, other actors often advance different frames, resulting in the alignment, contestation, and/or connection with the deeper paradigms held by those actors (148–49).

According to Rushton and Williams (149), the power and authority of a political actor influence the persuasive power of their framing discourse, the latter being informed by their understanding (i.e., paradigm) of how the world works. This consideration takes into account which actors can access the policy process, their relative positions of power, and the fact that their positions can be influenced by institutional cultures (159–60). Actor power is also influenced by their material/economic resources, their discursive abilities, and their expertise—both actual depth and breadth of expertise, and the authority attributed to such types of expertise, for example, biomedical expertise has substantial “soft power” in global health policy debates (159–60).

Applying Rushton and Williams's Framework to the EU

Rushton and Williams take a “maximalist” view of global health policy, which includes “those policies, both formal and informal, adopted on either an international or domestic level that respond to or affect health” (150, emphasis added). This article examines the global health angles of the EU's formal instruments—namely the Biotechnology Directive and the Orphan Regulation—which also represent parts of the EU's implicit global health policy at the time of their negotiation and adoption.

This article adopts Rushton and Williams’ argument that neoliberalism is the “deep core” structuring global health policy making (153) and applies it to the reality of the EU's global health policy making at the time that the Biomedical Directive and Orphan Regulation were negotiated. This assertion is consistent with the historical position of health protection to serve market interests in the EU treaties, which focused primarily on market creation and maintenance rather than an ambitious role in health promotion. Moreover, the EU lawmaking terrain historically privileged the (pharmaceutical) industry, which was seen as the legitimate stakeholder of DG Enterprise—the DG responsible for the pharmaceutical product files. By contrast, the structure of EU lawmaking failed to establish policy spaces for expertise and dialogue on global health issues affecting EU policy, and in doing so, deprioritized health interests. Because of these parallels between the original theory and our application to EU policy making, the present article does not focus on the deep core, but rather accepts this assertion and proceeds to focus on the paradigms/frames and power/authority components observed in the EU's internal legislative processes in the adaptation of EU legislation establishing incentives for biomedical R&D. Rushton and Williams propose several influential paradigms that fit with a global health discourse, including biomedicine, security, human rights, economics, and international development (157–58). These paradigms will be used as a classification tool (table 1).

Methods

This article is a case study of the political factors influencing the legislative processes behind the adoption of two EU biomedical acts. Examining the lawmaking process and language adopted in the final text reveals the persuasive power of different political factors involved.

The cases include the Biotechnology Directive and the Orphan Regulation. These are well-suited cases to examine the EU's role in global health because, although the EU lacks an explicit competence for global health, the EU historically manifests its global health interventions in the pharmaceutical and biotechnology sectors, where it is competent to promote the functioning of the internal market and free movement of these goods. Moreover, the EU has historically used “soft” policy measures, such as financing incentives for product development (e.g., EU Framework Programme funding for health interventions for global health) (Perehudoff et al. 2021) to exert its influence over global health policy. The scope of the analysis is limited to the second Biotechnology Directive proposal adopted in 1998; it does not concern the first such proposal (EC 1988).

The analysis is guided by the following research subquestions adapted from Rushton and Williams (2012: 159–62):

• Power/authority:

  • ▪ Which communities have a visible stake in the adoption of an EU act?

  • ▪ Which EU institutions are involved in the legislative procedure? Which institutions/individuals provide leadership, and who is excluded from the legislative process? In which ways is procedural power evident?

  • ▪ Which communities of experts are referenced and deployed in negotiations?

  • ▪ Is contestation between different paradigms/frames apparent in the legislative process, and how is such contestation mediated or settled?

  • ▪ Is there evidence that actors without traditional material power have influence on the legislative outcomes?

• Paradigms/frames:

  • ▪ How are discussions of a global health issue framed in the legislative procedure? Which competing frames are brought to bear? How well do they resonate with the major paradigms of global health?

  • ▪ Who voices particular framings, within which institutional contexts, and how do other actors in the legislative process react to these framings (i.e., are they supported, opposed, repeated in other contexts, etc.)?

  • ▪ Which authorities or texts are cited in support of a particular framing?

Official EU documents relating to the legislative procedure for these cases were gathered from eight EU archives. All documents were searched by using the search function for the predefined search terms (i.e., synonyms such as [Third] world, global, international, foreign, third/developing country/countries, Asia, Africa, North/South America, and Indigenous and antonyms such as Europe(an), nation, state, and developed countries). Relevant text was extracted as direct quotations and organized according to the institution, its place in the legislative process, and the document title. The extracted text was categorized according to paradigms (see table 2) and synthesized, alongside relevant academic literature, to answer the research subquestions. Afterward, the results for both cases were compared, and trends were identified.

Results

This analysis first identifies the EU institutions and actors involved in the legislative processes. Second, the salient frames and paradigms invoked by EU institutions throughout these processes are described. Last, a critical analysis is conducted that concerns the role of power and authority of these institutions and communities in relation to the frames and paradigms they use by combining evidence from official documents with academic literature. The persuasiveness of these political factors is illustrated by the relative success or defeat of key global health amendments. These amendments enjoyed relative “success” in the negotiation of the Biotechnology Directive, that is, by acknowledging a place-of-origin requirement, albeit in a recital. This is in contrast to their “defeat” in the Orphan Regulation, where an amendment proposing a Community strategy on R&D for tropical diseases was rejected.

Figure 2 shows the institutions, legislative procedures, and timelines that the negotiations of the Biotechnology Directive and Orphan Regulation followed. Outside of the EU institutions, the proposal for the Biotechnology Directive concerned farmers, breeders, and agricultural (trade) organizations; biotechnology researchers and industrialists; patient organizations; environmental protection and Indigenous communities; the authorities of third countries (e.g., from which genetic material may be sourced); and ethicists (Rothley 1997). The proposal for the Orphan Regulation concerned patient organizations, European regulators of pharmaceuticals, the pharmaceutical industry, the authorities of third countries (e.g., managing tropical or infectious disease outbreaks), and, to a lesser extent, medical-humanitarian organizations active in third countries (Cabrol 1999).

Biotechnology Directive Negotiations

The EC framed its proposal for introducing a standard level of patent protection on biotechnology to avoid distorting the internal market and to create R&D incentives for industry by providing greater legal certainty to inventors and harmonizing disparate patent rules among member states (EC 1995: recitals 2–3, 5), which resonates with an economic paradigm (see table 2). The EC also used a biomedical paradigm, advocating for the prevention and treatment of diseases by leveraging the patent system to promote R&D (recital 14). These frames and paradigms were echoed by other actors throughout the legislative process, such as the European Economic and Social Committee (EESC), the EP, and the Council, and were retained in the adopted text. The EESC cautioned that international agreements should ensure the respect of patent rights while ensuring these countries have access to these new technologies (EESC 1996: para. 4.11.2), which resonates with a human rights paradigm.

In response, the EP—and within that, the Committee on Development and Cooperation (DEVE),² and to a limited extent, the Committee on Environment, Public Health, and Consumer Protection (ENVI)³—questioned whether the EC's proposal would respect Indigenous rights and the principles of fair governance of (genetic) material sourced from developing countries in accordance with the CBD (Rothley 1997: paras 2.2–2.4, 4.1–4.4). These critiques, framed as an imperative to ensure biotechnologies are disseminated in the “third world,” embodied a global human rights paradigm that resonated not only with the lead EP committee (Legal Affairs and Citizens’ Rights) but also the EP's plenary. As a result, the EP proposed amendments to the recitals aiming to highlight the importance of third countries’ sovereignty over their resources, technology transfers, and benefits sharing (EP 1997: recitals 33e–j). These recitals were bundled by the EC into recital 55 referencing the Council decision on the EU's accession to the CBD and adopted as recital 55.

More importantly, the EP proposed the new article 8a(1), making the granting of a patent conditional on the disclosure of the material's geographical place of origin accompanied by evidence from “the patent authorities that the material was used in accordance with the legal access and export provisions in force in the place of origin” (EP 1997). The adoption of article 8a(1) would ensure the enforcement of some CBD principles under EU law. However, unlike recital 55, a global human rights paradigm and access to technologies frame were unsuccessful at persuading the EC in this instance, which rejected article 8a(1) in its revised proposal, claiming that it would go beyond the EU's commitments in international law and would be incompatible with personal data protection (EC 1997a: 1).

The Council agreed with the EC's concerns regarding article 8a(1) in the common position, and additionally found it difficult to verify the information requested from patent authorities in various third countries (Council 1998: C110/29). Rather than entirely rejecting the principles behind article 8a(1), the Council appeared to agree with the EP's global human rights paradigm and fair sourcing/genetic governance because it proposed a softer version of the article: recital 27. This recital states that a patent application that uses biological material originating from plants or animals “should, where appropriate, contain information on the geographical place of origin of such material” (C110/19). It was ultimately adopted in the final text.

The adopted directive lost explicit references to (third) countries’ sovereignty over their resources, access and technology transfer, and benefits sharing. Nevertheless, it retained recitals requiring that patent applications in the EU disclose the source material's origin, and that the directive is implemented coherently with the member states’ and the EU's CBD commitments.

Orphan Regulation Negotiations

The EC framed the Orphan Regulation proposal as a response to the insufficient (return on) investment for the R&D of medicines for rare conditions and the risk of distorting the internal market (EC 1998: 3) (see table 2). Besides this economic paradigm, the EC also adopted biomedical and human rights paradigms (albeit neither was globally oriented) by framing its proposal around the need for patients afflicted with rare conditions to enjoy the same quality of care, medical advances, and medicines of assured quality, safety, and efficacy as other patients (recitals 2, 7). These framings, adopted in the final act, are consistent with the Council resolution on orphan drugs (Council 1995).

Curiously, the EC's proposal also leveraged global human rights and biomedical paradigms to justify its Communitywide definition of rare conditions as having a prevalence of 5 or fewer in 10,000 people, which was a major objective of the proposal. The EC suggested that this threshold would not only serve European patients but also could potentially incentivize the R&D of medicines for diseases that are “very widespread in the Third World,” for example, tropical diseases, but that are uncommon in Europe (EC 1998: 8). However, these frames were only present in the explanatory memorandum and were not translated into legal text. The ESC's opinion echoed the EC's economic and human rights paradigms while introducing a development paradigm by suggesting that Community action on rare diseases, particularly diseases “widespread in other parts of the world,” would “place Europe at the centre of solidarity with the developing countries” (EESC 1999: paras 3.1.1, 3.1.6).

The lead EP committee (the ENVI committee) adopted the concerns of a politically “weaker” committee by providing an opinion (the DEVE committee) questioning whether the proposal and its potential impacts on the R&D of medicinal products for tropical diseases might be too optimistic, citing experience from the United States (Cabrol 1999: 32–36). DEVE's critique led the EP (1999: C175/62) to propose recital 2(a):

This amendment is rooted in a global biomedical paradigm with the phrase “[to] enable the main infectious diseases currently prevailing in developing countries to be kept under control” referring to a mild health security paradigm. This framing did not persuade the EC, which rejected recital 2(a) in its revised proposal without further elaboration other than that the EC accepted amendments that generally clarified or elaborated on the original text without altering its “fundamental principles” (EC 1999).

The Council largely accepted the EC's revised proposal with a few minor amendments that did not touch on the paradigms/frames already discussed (Council 1999); hence recital 2(a) was not reinstated in the final adopted act. The final act lacks any reference to global health paradigms and frames even though they partially formed the impetus for the initial definition of rare diseases in the EU.

Analysis of Power and Authority

The above outcomes should be contextualized by the power and authority of the actors and institutions involved.

The codecision procedure, followed in both cases, establishes the procedural powers of the EU institutions. Importantly, the codecision procedure gives the EC the right of legislative initiative, and it makes the EP a colegislator together with the Council, giving the EP the power to approve, amend, or reject the proposal in the first reading and the Council position in the second reading (article 189b Treaty Establishing the European Community (TEC) Maastricht, article 251 TEC Amsterdam). Although this article does not examine the first Biotechnology Directive proposal, it is notable that the EP rejected the Council position during the second reading of that proposal. This was perceived as a significant political defeat for the EC, which, Cloatre (2006: 353) argues, made the EC more conscious of, and potentially more responsive to, the anticipated and actual (ethical) concerns of the EP toward the EC's second Biotechnology Directive proposal. The EP's power in the codecision procedure (vis-à-vis other EU institutions) increased further under the Amsterdam Treaty, which simplified the codecision procedure (Rasmussen 2012: 736). After receiving the EC's proposal in the first reading, the EP may propose an amended act (by simple majority). If the Council approves this, the act may be adopted, hence concluding the negotiations after the first reading, as occurred with the Orphan Regulation (article 251 TEC Amsterdam).

The EU had limited competences regarding (global) health under the TEC. This, together with the responsibility for the pharmaceutical and (bio)technology files being allocated to market-oriented DGs (Biotechnology Directive: DG Internal Market and Financial Services; Orphan Regulation: DG Industry), paved the way for the EC to use its power of legislative initiative in these two instances to primarily serve the functioning of the internal market (article 100a TEC Maastricht, article 95 TEC Amsterdam), which was the resulting legal basis in both cases. The relatively sparse attention in both proposals to globally oriented paradigms, such as global human rights or global biomedicine, is consistent with the fragmented position of global health across multiple DGs during the late 1990s, diffusing responsibility and resources across DGs for addressing (global) health issues in Community policies and their implementation. The resulting economic paradigm that predominates in the EC's proposals is consistent with the primary concerns of industry associations, who were considered to be the natural stakeholder group that the market-oriented DGs leading these files should consider (Cloatre 2006).

In these two cases, the EP demonstrated some of its hallmark functions: normative actor, transmission belt, priorities influencer, and political player in EU external (health) relations. The EP's attempt to introduce a place of origin requirement into the Biotechnology Directive is consistent with Rollet's (2022: 2–4) conception of the EP's function as a normative actor by proposing to the EC and Council “to align with international norms” such as technology transfer and benefits sharing enshrined in the CBD.

Both legislative processes highlight the EP's emerging role as a transmission belt relaying the concerns of civil society regarding the EC's proposals (Rollet 2022: 2–4). Through interviews with policy stakeholders involved in the adoption of the Biotechnology Directive, Cloatre (2006: 355–56) revealed that nongovernmental organizations were critical in problematizing the issue of “bioprospecting” and transplanting it from the international level (CBD) to the European level. The pressure from international and domestic debates around biopiracy, together with the EP as the nongovernmental organizations’ primary point of contact, resulted in support for these global health concerns (355–57). Curiously, the EP's first report on the Biotechnology Directive proposal is characterized by a lack of perspectives from global health stakeholders, while, by contrast, European industrial/trade associations, patient organizations, and other interest groups are quoted in the report (Rothley 1997: 35). In the Orphan Regulation, the EP had less work to do as a transmission belt between civil society and EU lawmakers. This is because of the early consultation and strong representation of interests of European patient organizations in the EU institutions’ positions (EC 1998: 5–6; Scapagnini 1999: 18), which aligned with the EC's economic and biomedical paradigms and interests of the lead DG's primary stakeholder group: European industry. Curiously, the voices of any global health representatives were scarcely acknowledged in the EU institutions’ explanatory statements, except for data from Médecins sans Frontieres, which was cited by the DEVE committee in support of introducing recital 2(a) into the Orphan Regulation (Cabrol 1999: 35).

Additionally, both legislative processes demonstrate how the EP attempted to be a priorities influencer by convincing “the EC and Council to adopt priorities and to follow objectives that were not initially considered by the EC” (Rollet 2022: 2–4). However, both cases show that the EP was only successful at influencing priorities that aligned with the EC's initial frames, prevailing economic and biomedical paradigms, and proposed policy solutions that flowed from those frames. The EP's proposal for disclosure of the place of origin in the Biotechnology Directive (article 8a[1]/recital 27) may have been successful partially because it complemented, but did not compete with, the EC's overarching policy choice to introduce patents on biotechnology. By contrast, the EP's proposal in the Biotechnology Directive to develop a Community strategy on R&D for diseases in the tropics (recital 2[a]) demanded an entirely different policy tool than the EC's proposed market exclusivity, which may have contributed to its rejection.

The relative “power” of the leading actors within the EP may partially explain the relative success of these two global health amendments. An important indicator may be the relative power and authority of the EP's rapporteurs on these files, which, according to Costello and Thomsen (as cited in Rasmussen 2012), is vested in the size/popularity of the rapporteur's political group and their affiliation with a national party. The EP's rapporteur on the Biotechnology Directive, Willi Rothley, may have enjoyed negotiating success vis-à-vis the Council because of his membership in the large Socialists and Democrats EP political group, which was also strategically targeted by civil society because of the group's size and influence, to counter the problem of biopiracy in the directive proposal (Cloatre 2006: 357–59). By contrast, the EP's rapporteur on the Orphan Regulation, Christian Cabrol, was part of the small and ill-fated Union for Europe group in the EP and a national political party of declining popularity in France, which was unlikely to give him a privileged negotiating relationship with the Council.

The negotiations of the Biotechnology Directive may illustrate how the Council can function as a backup advocate of a global human rights paradigm when the EP is unable to persuade the EC. This function of the Council may be triggered or enhanced when a member state supports the rights-based proposal being challenged by the EC. For example, unpublished Council minutes revealed that the Danish delegation reportedly sought to reintroduce article 8a(1) into the proposal (as reported by Cloatre 2006: 353). Danish NGOs (although lacking traditional power in EU legislative processes), left-wing national parties, and members of the Danish government “widely accepted” the requirement for the disclosure of place of origin in the Biotechnology Directive (358).

Another factor influencing the success of an amendment is the intensity of contact between EU lawmakers before or during negotiations. For example, the second Biotechnology Directive proposal followed the ill-fated first proposal, which is a process that would have facilitated ample (in)formal contact between EU legislators, potentially leading to greater mutual understanding during the negotiations of the second proposal. Although the Orphan Regulation was the EC's first proposal, and therefore lawmakers’ first engagement with one another on these issues, it flowed from the Council resolution on orphan drugs (Council 1995). Here the Council used economic and biomedical paradigms to call on the EC to take legislative action to incentivize the R&D of medicines for rare conditions. This guidance could have given the EC important insight into the Council's mindset and the scope, content, and framing of an acceptable legislative proposal for member states.

Discussion and Conclusion

This article has demonstrated how various frames and paradigms were advocated by actors wielding power and authority to different degrees throughout the legislative processes giving rise to the Biotechnology Directive and the Orphan Regulation. Global human rights and global biomedical paradigms were advanced through the EC's policy proposals and/or the EP's amendments motivated by the pursuit of global health equity and addressing patients’ medical needs worldwide. Whether or not these proposals/amendments were adopted in the final text reflects a unique combination of political factors that suggest that the EU was an internally fragmented and highly politicized political player on global health matters in the late 1990s.

With its power of legislative initiative, the EC framed the initial challenge of incentivizing the R&D of health-related technologies and its policy choices around economic and biomedical paradigms that focused on the needs of European industry and patients, respectively (except for the Orphan Regulation, where the EC used a global biomedical paradigm to justify its definition of rare diseases). These frames, and the EC's proposed policy choices that flow from them, generally garnered much support throughout the legislative processes, suggesting the EC's dominance in agenda setting. However, the codecision procedure (allocating increasing power to the EP) could have led the EC to take colegislators’ sensitivities (and those of external stakeholders who would lobby colegislators) more seriously at an early stage of proposal drafting.

The EP contested some of the EC's frames and the related policy choices, using global human rights and global biomedical paradigms. The EP's relative success at securing a reference to the disclosure of place of origin in the Biotechnology Directive could be attributed to its coherence with the EC's policy choice (rather than to proposing an entirely different policy choice), and to the EP's strong rejection of the first proposal. Moreover, the EP's success could be influenced by the power of its rapporteur in the intra- and interinstitutional negotiating process, combined with the demands and support of external global development advocates targeting the EP and the Council.

By contrast, the EP's global biomedical paradigm was unsuccessful at convincing the EC and the Council of the need for a commitment to develop Community strategy on the R&D of medicines for the tropics in the Orphan Regulation. A critical difference between the EP's global health amendments in the Biotechnology Directive and the Orphan Regulation is that in the latter, the EP's demand was a departure from the EC's initial policy choice (i.e., market and other R&D incentives), and to be adopted, the amendment would require colegislators to align with the same paradigm. Failure of the EP to convince the EC and the Council could be attributed to factors including the weak political power of the EP's rapporteur; the lack of a clear civil society voice representing global patients in this process, and the strong concurrent presence of European patient groups advancing positions that aligned with the EC's paradigms and European industry's interests; and potential competing priorities of member states in the Council.

Limitations and Future Research

The intrainstitutional and interinstitutional factors that may lead to the success of a particular negotiating position or concrete amendment are plentiful; however, they could not be extensively verified in this research, given that nearly two decades have passed since these acts were adopted, which limits our access to firsthand accounts of these negotiations and the online resources from stakeholders outside EU institutions. We have mitigated this challenge by relying on the robust record of official EU documents and supplementing it with published academic literature.

A key question that remains is to definitively understand how EU institutions mediate conflicting views on global health policy proposals and reach an agreement. Future research on more recent legislative processes, including the revision of the EU's general pharmaceutical legislation, could explore the roles of informal contacts, trialogues, or other negotiations between the colegislators (EP and Council) and at what stage in the legislative process these occur (Luh and Baltag 2021), and the influence of the EP's recently established Public Health Committee. Moreover, the launch of the EU's Global Health Strategy in 2022 paves the way for stronger consideration of global health in EU health lawmaking, which should be the subject of future research.

What Future for the EC's Global Health Strategy?

The present analysis offers much scope to reflect on the political factors affecting the future of the EU's Global Health Strategy. The EC has now assigned a formal home to global health in DG SANTE, which likely is combined with some increase in resourcing/capacity. Whether it will be enough to increase policy coherence for global health across all DGs remains to be seen. The procedural power of the EP has only increased, and the institution has positioned itself as a human rights defender on a variety of issues, including global health (EP 2022). At the same time, EP elections deliver an increasingly conservative parliament that may shy away from a global human rights paradigm on some health issues in favor of more inward-looking paradigms related to economics or health security; for example, see the EP report on the COVID-19 pandemic (Montserrat 2023). After the pandemic, it could be expected that a health security paradigm is increasingly persuasive to legislative actors, and in particular the Council, as national elections and administrations can rise and fall on matters of protecting domestic health (care). These shifts may not be conducive to proposing, monitoring, and implementing a progressive, human rights–oriented EU policy for global health, as was partially observed in the present study. Finally, today there are a plethora of external bodies (e.g., WHO, the Bill and Melinda Gates Foundation) and civil society representatives of global health interests (e.g., Global Health Advocates, Médecins Sans Frontières, Oxfam) actively striving to advise/influence or even fund EU institutions for their work on global health issues. Therefore, in the future the EU will undoubtedly continue to be a prominent global health actor. However, the extent to which its leadership will advance human rights and global health equity, and/or the EU's own economic growth and/or health security, will be determined by a range of frames/ideas, actors, and power dynamics at play within the EU's legal order.

Acknowledgments

This research arises in part from funding awarded to Katrina Perehudoff from the Netherlands Organization of Scientific Research, the Amsterdam University Funds, and the Amsterdam Centre for European Studies at the University of Amsterdam. Part of this research was conducted within the master of international and European law at the University of Amsterdam.

Notes

References