During a 1995 meeting of the Islamic Organization for Medical Sciences (IOMS), medical experts and Islamic jurisconsults deliberated on “Judically (sic) Prohibited and Impure Substances in Foodstuffs and Drugs” (Recommendations of the 8th Fiqh‐Medical Seminar ). The ethico‐legal discussions resulted in a religious decree that considered it permissible for Muslims to use medicines that contained “gelatin formed as a result of transformation…of a judicially impure animal (e.g., pig)” (Recommendations of the 8th Fiqh‐Medical Seminar ). Attending this meeting were several health policy stakeholders, including representatives of the World Health Organization (WHO). Motivated by a desire to “relieve all Muslims…from the embarrassment they feel” when taking medicines with porcine gelatin, WHO representatives disseminated the verdict widely (Gezairy ), and as a result vaccine advocates came to promote the Islamic permissibility of using vaccines with porcine components.

More than a decade later, in 2008, the Indonesian Ulema Council (MUI) issued a religious verdict declaring the GlaxoSmithKline (GSK) meningitis vaccine to be impermissible to use, ḥaram, because porcine was used in its production (Yessir ). Eventually the MUI permitted use of the vaccine by considering an extreme necessity, ḍarurah, to exist (Sagita ). This conditional permission was revoked in the following year when the MUI decreed the meningitis vaccines produced by Novartis and Tian Yuana to be porcine‐free and therefore ḥalal (Hapsari ; Jakarta Post ).

In this article, I examine the Islamic bioethical deliberations around the use of vaccines with porcine components from an applied Islamic bioethics perspective. More specifically, I seek to explore how ground‐level actors, in this case health policy stakeholders, utilized the aforementioned verdicts. Therefore I will begin by first reviewing the juridical decrees and then by recounting how several health policy stakeholders used these verdicts, by way of media reports and documents available in the public domain. My analysis will next highlight aspects of the particular Islamic ethico‐legal arguments noted by the juridical authorities in the final verdicts in order to illustrate more general concepts within Islamic law. I will argue that certain core elements of the Islamic ethico‐legal tradition were overlooked by policy stakeholders utilizing the IOMS verdict, and that these elements must be accounted for when using religious decrees to inform public policy. While Islamic juridical council deliberations are extensive, and their proceedings offer much insight into the fiqhi frameworks and deliberative processes used by jurists and the dissenting voices at the proverbial council table, such materials are not primary sources to understand the usage of the consensus final verdicts by Islamic bioethics consumers, nor are they easily accessible to nonjurist health professionals (by accessible I mean both in terms of physical access, and in terms of understanding). Since health policy actors seek and use verdicts, I restrict myself to pointing out the ethico‐legal frames and constructs noted in the final verdicts, where possible. I will conclude my commentary by offering several recommendations that may facilitate the more judicious use of verdicts in policy‐relevant Islamic bioethics discourse.

The Story

Recounting the Narrative through the Lens of Applied Islamic Bioethics

As we turn to examining the IOMS and MUI verdicts more closely, defining a few concepts will aid the reader in placing this study within Islamic bioethics scholarship.

The study of fatawa (singular fatwa) and qararat (singular qarar) represents the cornerstone of Islamic bioethics research. Fatawa and qararat play a role similar to that of legal response literature in Halakhaic reasoning, and are nonbinding ethico‐legal opinions of traditional Islamic jurisconsults and juridical councils. These judgments utilize a method of religious‐text prioritization and ethico‐legal argument that is mapped out in Islamic moral theology and jurisprudential theory, usul al‐fiqh. Fatawa and qararat are used ubiquitously by the laity (Muslim patients and physicians) to guide health‐care behaviors, by Islamic bioethics researchers to derive normative goals for medical practice, by policy actors to craft regulations and law, and by religious leaders to advise their communities on ethical challenges in health care. Fatawa and qararat, as expressions of the Islamic ethico‐legal tradition, further represent a window into the jurisconsult's mind as he/she approaches modern medicine and are central to applied Islamic bioethics scholarship. Applied Islamic bioethics is a discipline that seeks to (1) examine the ways in which Islamic authorities approach ethical questions raised by Muslim health‐care providers, religious leaders, and patients in their dealings with medicine and biotechnology and to (2) study the application of religious verdicts by health‐care providers, patients, and health‐care stakeholders. Thus the field is founded upon the study of fatawa and qararat.

With this introduction I argue that a neglect of three concepts contributes to the possible misreading of the IOMS verdict. The first concept is the distinction between a fatwa and a ḥukm. I contest that the IOMS and MUI verdicts are morally and legally nonequivalent on the basis of this distinction. The second concept is that schools of Islamic law differ in their acceptance of ethico‐legal constructs. Therefore verdicts using ethico‐legal reasoning based on a particular school of law may be considered deficient according to other schools of law. I will use the construct of istiḥāla to elaborate upon this idea. The last concept relates to the differentiation between a normative and a contingent ruling. This notion will be illustrated by examining how the verdicts cite ḍarurah, extreme necessity.

Istiḥāla, Complete Transformation, across the Sunni Schools of Law

When reading fatawa, it is critical to note the ethico‐legal constructs employed by jurisconsults when making their argument. The constructs used by legists adherent to one school of law may not be considered valid by legists belonging to another school of law. Thus a particular verdict may not have resonance across schools and its generalizability is challenged. This feature within Islamic ethico‐legal theory is illustrated in the IOMS's reliance upon istiḥāla to deem porcine‐based medicines permissible.

What exactly istiḥāla signifies physically and how the construct should be used in ethico‐legal assessment is a matter of continuing debate within the Sunni legal schools. Generally defined as tabdeel al‐maḥiyyat or tabdeel al‐ḥal, istiḥāla signifies “(the) chang(e) in nature of (a)…substance to produce a different substance in name, properties and characteristics” (Recommendations of the 9th ). Looking to the natural world and at Prophetic examples, classical Islamic jurists noted that while the Qur'an and the Prophet prohibited drinking wine, the consumption of vinegar was allowed (al‐Naisaburi , 23:5091). The same type of circumstances and judgments surrounded the use of the tanned hides of dead animals. These paradigmatic examples, where an Islamically unclean (najis) substance underwent a change in character such that the resulting substance was considered clean and permissible to use, informed the techno‐scientific imagination of the medieval jurists such that the construct of complete transformation, istiḥāla, came into the vocabulary of Islamic law. Technically, then, istiḥāla signifies the transmutation of a ḥaram material into a ḥalal substance. As noted above, the IOMS decrees invoke istiḥāla to deem porcine‐based vaccines permissible.

From an applied Islamic bioethics viewpoint the problem lies not in the verdict's ethico‐legal reasoning; rather, it is that there is no mention in the final verdict, and perhaps thereby in the synopsis disseminated by the WHO, that the Sunni schools of law disagree on whether istiḥāla applies to porcine products. Thus stakeholders who try to use the fatwa to inform health policy may mistakenly construe a false consensus of opinion and believe that the fatwa is universally acceptable.

In reality there is a considerable degree of variance within and across the Sunni legal schools as to whether istiḥāla applies to products of pig origin. Briefly, the prevailing opinion in the Hanafi school (al‐Hattab , 1:97; Ibn Nujaym , 1:294) and Maliki school (al‐Dusuqi , 1:97; al‐Hattab , 1:97) is that istiḥāla can purify pig products. However, the Shafi doctrine is that porcine products do not fall under the purview of istiḥāla (al‐Shirbini , 1:236). The dominant opinion in the Hanbali school is debatable, with the majority view being that istiḥāla does not purify pig (al‐Dusuqi , 1:97; al‐Buhuti , 1:214–15; Ibn Qudamah , 1:86, 2:66), however one opinion of Imam Ahmad (Ibn Qudamah , 1:76), and the opinion of Ibn Taymiyyah and Ibn Qayyim al‐Jawziyyah is that porcine products are covered by istiḥāla (Ibn Qayyim al‐Jawziyyah , 2:15; Ibn Taymiyyah n.d., 21:70). It is important to note that there are minority opinions within the Hanafi school, like that traced to Imam Abu Yusuf (Ibn Humam , 1:202) that discount istiḥāla for porcine. While the IOMS juridical council (or any jurisconsult) is free to judge based on the opinion of another school, an istiḥāla‐based argument is by no means universally acceptable.

To reiterate my point, it is critical for policy stakeholders to recognize the inherent limitations of a particular fatwa when using it as the basis for health policy. One such limitation may stem from the usage of ethico‐legal constructs that are deemed valid by some schools of law and invalid by others. To accurately assess the acceptability of a particular fatwa within a community, policy stakeholders must therefore be aware of the ethico‐legal proclivities of a specific Muslim community, and be cognizant of whether contested constructs are employed within the ethico‐legal reasoning of a particular fatwa.

The IOMS verdict's universal appeal is challenged by its reliance on istiḥāla. Given this limitation, the WHO's suggestion that the verdict would “relieve all Muslims” (Gezairy ) may be an overstatement of its potential relevance within the global Muslim community. Moving to the MUI, their fatwa declared the GSK vaccine ḥaram due to porcine components used in its production. This ruling may, in part, be explained by the fact that most Indonesian jurisconsults incline toward the doctrinal Shafi position that istiḥāla does not apply to porcine. A detailed analysis of their fatwa would provide greater clarity on the ethico‐legal arguments they employ to argue for the ḥaram status of the vaccine. However, this type of analysis is unnecessary to make the point that the MUI was free to offer their own verdict even while the IOMS was being circulated because the IOMS has no legal authority over Indonesian Muslims.

Ḍarurah‐Based Rulings: Considering Normative Assessments in the Islamic Ethico‐Legal Tradition

Another critical concept that may be overlooked by stakeholders in seeking to apply Islamic verdicts is the difference between a normative and a contingent ruling. This element of Islamic ethico‐legal deliberation may not be readily noticed by nonlegal specialists, and as a result, a ruling with a limited scope may be seen as more widely applicable. As a rule of thumb whenever a verdict cites ḍarurah as the basis for judgment, the resulting ethico‐legal opinion is nonnormative.

Technically ḍarurah is an Islamic ethico‐legal concept that describes circumstances of extreme necessity. Its usage in Islamic ethico‐legal argumentation is captured by the legal maxim, al‐darurat tubih al‐mahzurat—extreme necessity renders the impermissible to be permissible. This maxim is derived from several Qur'anic verses and Prophetic statements that indicate extreme circumstances may require normative prohibitions to be overturned. A verse that is of particular relevance to this discussion reads:

Say (O Prophet): I find not in that which is revealed unto me aught prohibited to an eater that he eat thereof, except it be carrion, or blood poured forth, or swine‐flesh for that verily is foul or the abomination which was immolated to the name of other than Allah. But whoso is compelled (thereto), neither craving nor transgressing, (for him) Lo! your Lord is Forgiving, Merciful. ([al‐An'am:145] Pickthall )

Even while forbidding the consumption of pig, the verse puts forth an exception noting that “whoso is compelled” may partake of the forbidden food.

Another related legal maxim states al‐mushaqqa tajlabu al‐tayseer, that hardship allows for bringing about ease (Ibn Nujaym , 64). Particularizing these principles, the four Sunni schools of law allow an extreme necessity, ḍarurah, to overturn a normative prohibition when a core objective of the Islamic ethico‐legal code is at stake. These core objectives, maqaṣid, of the Islamic ethico‐legal code are the protection of religion, life, intellect, lineage, and property (Auda ; Padela ). Defining what constitutes an extreme necessity is controversial and can vary from Islamic jurisconsult to jurisconsult, and from legal school to school. Circumstances that lead to invoking a ḍarurah are, by definition, motivating the exception and thus the judgment represents a nonideal scenario. In Islamic bioethics, ḍarurah is invoked with considerable variance and ambiguity.

The IOMS verdict does not rely on ḍarurah; rather, it considers istiḥāla as the operative construct allowing the use of porcine‐based medicines. One may, therefore, conclude that the IOMS judgment is a normative assessment. However, the legists offer a caveat limiting the scope of their permissive ruling by stating that “(we) recommends (sic) the necessity of utilizing skins and bones of (ḥalal) animals for the purpose of extracting gelatin…as this will…avoid sources that might be juridically unacceptable” (Recommendations of the 8th ). It appears, then, that using a vaccine comprised of porcine gelatin seems to be less than ideal and that nonporcine gelatin is the preferred norm.

The MUI initially declared the GSK porcine‐based vaccine to be ḥaram but subsequently permitted its usage by citing ḍarurah. For these scholars, the conditions that came together to meet the threshold of ḍarurah were the lack of a nonporcine alternative and the Saudi mandate of meningitis vaccination prior to Hajj.

Noting the normative or contingent nature of a ruling is integral to appropriately applying the fatwa. Accordingly if the approval of porcine‐based medications is based on several contingencies, then it follows that the verdict is actionable only for as long as those particular circumstances remain in effect. In the health policy realm, a further implication arises: the conditions that create the social circumstances that necessitate a contingent ruling are themselves intervention points. In other words, when a ruling is motivated by circumstances that constitute ḍarurah, health policy stakeholders may work to change the contexts that impede a more normative ruling.

Although the final IOMS verdict is not motivated by ḍarurah the text suggests that using porcine gelatin is not ideal. This qualification seems to have been overlooked by vaccine industry stakeholders as they promote the “Islamic” sanction of their porcine‐based vaccines (Padela ). For example, a medical information specialist with Sanofi Pasteur stated that their porcine‐based vaccines have been approved by Islamic authorities and referenced the WHO letter (Thallmeyer ). Furthermore, interpreting the ruling as normative allowed the industry to consider the status quo as acceptable to the Muslim world.

The 2008 MUI verdict changed this evaluation in that declaring porcine‐based vaccines ḥaram created the market‐based impetus to create meningitis vaccines that were porcine‐free. Even though the MUI allowed for the use of porcine‐based vaccines by means of ḍarurah, it was clearer to health policy stakeholders that this permission was conditional. Both verdicts had tangible impact upon the vaccine industry.

Final Remarks

In this article I examined how health policy stakeholders utilized the IOMS and MUI verdicts on the permissibility of using vaccines. I highlighted aspects of the arguments employed in these verdicts to point out key concepts within the Islamic ethico‐legal tradition that need to be taken into account when using Islamic verdicts to inform health policy. Specifically, I commented on (1) the distinction between a fatwa and a ḥukm, (2) the nonuniversal acceptance of Islamic ethico‐legal constructs across the schools of law, and (3) the differentiation between a normative and a conditional ruling. In conclusion, I offer several recommendations for the producers and consumers of Islamic bioethical discourse that will facilitate products that better meet the needs of Muslim patients, physicians, religious leaders, and policy stakeholders.

First, I recommend that Islamic jurisconsults (1) clearly note the validity of the particular ethico‐legal constructs employed in their verdicts across the Islamic schools of law, (2) unambiguously delineate the circumstances their decrees address, and (3) specify conditions under which the ruling is operable. In the past, individuals and state actors often sought fatawa from local Islamic authorities. This “neighborhood” fatwa meant that the issuing Islamic authority was well known and trusted by the seeker of the fatwa, and that the fatwa was communicated through the medium of a jurist who could explain the ethico‐legal rationale behind it, and the conditions under which action was due upon a fatwa.

In the era of mass media, global interconnectedness, and with the advent of the Internet, Islamic verdicts are now part of a global public discourse. The increased number of options presented by the myriad of extant fatawa allows the seeker to select and act upon the fatwa that most clearly suits his or her circumstances, and is viewed as the most accurate description of the Divine law. At the same time, however, the increased proliferation of fatawa creates the scenario where those seeking to implement a fatwa may be far removed from the Islamic scholars who issue them. The “transnational” fatwa opens up the door for misappropriation and misunderstanding as the verdict comes to be decoupled from context, and removed from the interpretative medium of a trained Islamic jurist. Therefore clearly delineating the circumstances a particular fatwa addresses, and the conditions under which the fatwa is actionable, will make it easier to identify whether a specific verdict is transferable across time, space, and context. Moreover, by clarifying whether the ethico‐legal constructs employed by a jurist are universally acceptable across the Islamic schools of law would facilitate the critical evaluation and successive refinements of the fatwa. In this way, Islamic bioethical discourse can adapt to better meet the changing needs of the Muslim community while at the same time maintaining fidelity to the ethico‐legal tradition.

Additionally, I believe that Islamic juridical authorities must consider the policy implications of their verdicts. I do not mean to suggest that jurists do not routinely take into account the social realities impacting their ethico‐legal deliberations; however, I suggest that policy‐level ramifications may need to be more central to the deliberative processes. As fatawa participate in a global Islamic bioethics discourse, and transnational health policy stakeholders disseminate and use Islamic rulings, anticipating the downstream policy (mis)application beforehand may impact the content of the ruling, as well as compel jurists to be more lucid in the writing of the final verdict.

To more fully consider the ways potential rulings would be used in the public policy realm, a multidisciplinary engagement is needed within Islamic juridical councils. Fiqh academies tend to predominately involve medical experts and Islamic jurists, yet Islamic theologians, health policy experts, social scientists, patients, and others may all serve as content‐experts in bioethical deliberation. By bringing into dialogue these oft‐overlooked experts, juridical councils can spawn an “Islamic” bioethics whose practitioners are literate in both the Islamic sources (the texts) and the social realities (the contexts), and effect a discourse that represents a living tradition engaging with the complex bioethical challenges of modern times.

Acknowledgments

This article grew out of a presentation at the conference on “Islamic Bioethics: The Interplay of Islam and the West” that was held in Doha, Qatar, June 24–25, 2012. This conference was part of the project “Islamic Medical and Scientific Ethics (IMSE),” funded by the Qatar National Research Fund (QNRF) and organized by the Library of the School of Foreign Service in Qatar (SFSQ), Georgetown University in cooperation with the Bioethics Research Library, Georgetown University, Washington, DC. The article was also presented in partial form at the conference on “Health‐Related Issues and Islamic Normativity” at the University of Hamburg, Germany in June 2012. We thank Shaykh Amin Kholwadia, Prof. Ebrahim Moosa, and Shaykh Musa Furber for their insightful research, discussions, and encouragement that led to this article. We also note the assistance of Mufti Zubair Butt and Mufti Ehzaz for assistance with citations. The research leading to this manuscript was, in part, funded through the Robert Wood Johnson Foundation Clinical Scholars Program, and carried out as Visiting Fellow at the Oxford Centre for Islamic Studies.