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Forum
Halal pharmaceutical industry: opportunities and challenges Mohd Nor Norazmi1,2 and Li Sze Lim1 1 2
School of Health Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia Institute for Research in Molecular Medicine, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia
The expanding global Muslim population has increased the demand for halal pharmaceuticals. However, there are several challenges for this emerging niche industry, foremost of which is the need to establish a proper, wellregulated, and harmonized accreditation and halal management system. The current pharmaceutical landscape is crowded with many new companies entering the industry, spurred by the patent expiry of many innovator drugs and biologics. Even multinational companies are diversifying, producing generics and biosimilars to take advantage of the current situation and to stay competitive in the market. The increase in technological knowhow in many developing countries, especially Brazil, Russia, India, China, and South Africa (so-called ‘BRICS’) has propelled the businesses of many companies in these countries to become household names, not only in developing but also developed countries. The demand for affordable and quality healthcare has primarily come from consumers, who are now more knowledgeable about their needs. This enhanced understanding of health requirements has also brought about higher demands on the drugs consumed. From the Muslim consumers’ perspective, the demand comes in the form of whether a drug is halal or permissible in Islam. To a Muslim, the halal status of a drug assures that the product does not contain pork or other prohibited ingredients (such as other nonpermitted animal products or derivatives, or alcohol). In addition, it assures the consumer that the product has been prepared and manufactured using equipment that is dedicated for halal pharmaceuticals. It is further expected that any animal products or their derivatives used have to be sourced from animals slaughtered according to Islamic law [1]. The parallel for this is the Jewish kosher diet, which also prohibits the consumption of pork and other prohibited animal meat and their derivatives (http://www.kosher.jp/kosher/kosher. html). Therefore, halal pharma standards dictate that every step in drug preparation adheres fully to these requirements, including the source of the strain of microorganism, the type of media it has been cultured in, the containers and membranes used in the production process, the steps involved in the fill and finish processes, right up to the Corresponding author: Norazmi, M.N. ([email protected]). Keywords: Halal accreditation; Halal harmonization; Halal pharmaceuticals. 0165-6147/ ß 2015 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.tips.2015.06.006
packaging, until the product reaches the consumer. Perhaps the similarities between halal and kosher can also be analyzed to determine whether selected steps in the pharmaceutical production process can be reciprocally accepted under the different religious requirements. Opportunities Today, a quarter of the inhabitants of the world are Muslims. This figure is expected to grow by 35% over the next two decades, leaping from 1.6 billion to 2.2 billion by 2030 [2]. Even in markets where Muslims are a minority, when ranked by Gross Domestic Product at Purchasing Price Parity, large or developed nations, namely, the USA, Russia, UK, France, and Germany, are ranked among the top ten economies with Muslim buying power [3]. Driven by the potential lucrativeness of the industry, pharmaceutical giants, such as Novartis and GlaxoSmithKline, have attempted to come up with halal vaccines. With blockbuster drugs worth US$50 billion of market size going off patent this year [4], halal is an answer to raising the bottom line of the companies, because stringent halal certification processes once again set the companies apart. Traditional halal food regulatory authorities have also jumped at the opportunity, with countries such as Malaysia publishing their own halal standards [5]. The uniqueness of this standard is that it rides on the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), whereby the product has to first and foremost be certified to comply with safety, quality, and efficacy requirements under PIC/S standards before it can be certified halal. This would also demystify the notion that halal products are of lower quality. Challenges For the industry to thrive, there are challenges that need to be met to achieve a drug that is recognized by all Muslims as halal, and by non-Muslims as equal or superior quality. The major challenge is perhaps the need to put in place a wellregulated and harmonized accreditation and halal management system that is globally accepted. A good example is the antimeningococcal conjugated vaccine that has been certified halal by the Indonesian halal certification authority (http//www.id.novartis.com/news-detail-vc2010.html) but not by its Malaysian counterpart. In certifying products to be halal, certification bodies should comprise professionals (Muslims and non-Muslims) who are experts in both religious jurisprudence and science and technology. In fact, this approach is already being adopted by the Malaysian and Indonesian authorities. However, the technical capacity of Trends in Pharmacological Sciences xx (2015) 1–2
1
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Forum these regulatory agencies would need to be continually enhanced and harmonized to meet the anticipated increase in applications for halal drug approvals. This would enable reciprocal recognition by the various halal certification authorities for halal pharmaceuticals similar to the current practise for halal food and beverages. As the different types of production process within the pharmaceutical production chain seek certification, different types of question peculiar to each niche process are bound to crop up. Therefore, experts in specific production processes and drug development are needed to answer these questions. Other steps to strengthen the certification process may include introducing tests for DNA and protein sources, and publishing the list of halal pharmaceutical sources based on the available pharmacopoeia, to name but a few. In getting global recognition for halal, advocacy is needed to educate consumers that halal drugs are of a quality as high as, if not higher than, their non-halal counterparts. In halal branding, consumers, Muslim and non-Muslims alike, have to see halal products as wholesome, encompassing alternatives that do not compromise fundamental drug standards. Concluding remarks In the halal food industry, developed nations with minority Muslim populations are one of the biggest producers of halal products: Australia being a halal beef producer, New Zealand a halal lamb producer, and Brazil, a halal chicken
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producer. For the new market entrant into the pharmaceutical industry, whether they be a majority or minority Muslim country, it is logical to enter the market on a halal platform, because the foundation will be built on a differentiated global business model with added competitive advantage. To cater to the certification of this expanding industry, more efforts are needed to institute training of religious authorities on science and technology, as well as training scientific experts in basic religious requirements, and the development of scientific methods and literature to support the industry so that halal pharmaceuticals can enter the global market as smoothly as possible. Acknowledgments The authors would like to acknowledge the Apex Special Grant, Universiti Sains Malaysia for supporting their work on halal vaccine development. M.N.N. is a Fellow of the Academy of Sciences, Malaysia.
References 1 Halim, M.A.A. and Salleh, M.M.M. (2012) The possibility of uniformity on halal standards in Organization of Islamic Countries (OIC) country. World Appl. Sci. J. 17, 6–10 2 Pew Research Center (2011) The Future of the Global Muslim Population, Pew Research Center 3 Hunter, M. (2012) The emerging halal cosmetic and personal care market. Personal Care Mar. 2012, 34–39 4 Bloomberg Business (2013) Big Pharma’s Pa-tent Cliff, Bloomberg Business 5 Department of Standards Malaysia (2012) Halal Pharmaceuticals: General Guidelines, Department of Standards Malaysia
Forum
Halal pharmaceutical industry: opportunities and challenges Mohd Nor Norazmi1,2 and Li Sze Lim1 1 2
School of Health Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia Institute for Research in Molecular Medicine, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia
The expanding global Muslim population has increased the demand for halal pharmaceuticals. However, there are several challenges for this emerging niche industry, foremost of which is the need to establish a proper, wellregulated, and harmonized accreditation and halal management system. The current pharmaceutical landscape is crowded with many new companies entering the industry, spurred by the patent expiry of many innovator drugs and biologics. Even multinational companies are diversifying, producing generics and biosimilars to take advantage of the current situation and to stay competitive in the market. The increase in technological knowhow in many developing countries, especially Brazil, Russia, India, China, and South Africa (so-called ‘BRICS’) has propelled the businesses of many companies in these countries to become household names, not only in developing but also developed countries. The demand for affordable and quality healthcare has primarily come from consumers, who are now more knowledgeable about their needs. This enhanced understanding of health requirements has also brought about higher demands on the drugs consumed. From the Muslim consumers’ perspective, the demand comes in the form of whether a drug is halal or permissible in Islam. To a Muslim, the halal status of a drug assures that the product does not contain pork or other prohibited ingredients (such as other nonpermitted animal products or derivatives, or alcohol). In addition, it assures the consumer that the product has been prepared and manufactured using equipment that is dedicated for halal pharmaceuticals. It is further expected that any animal products or their derivatives used have to be sourced from animals slaughtered according to Islamic law [1]. The parallel for this is the Jewish kosher diet, which also prohibits the consumption of pork and other prohibited animal meat and their derivatives (http://www.kosher.jp/kosher/kosher. html). Therefore, halal pharma standards dictate that every step in drug preparation adheres fully to these requirements, including the source of the strain of microorganism, the type of media it has been cultured in, the containers and membranes used in the production process, the steps involved in the fill and finish processes, right up to the Corresponding author: Norazmi, M.N. ([email protected]). Keywords: Halal accreditation; Halal harmonization; Halal pharmaceuticals. 0165-6147/ ß 2015 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.tips.2015.06.006
packaging, until the product reaches the consumer. Perhaps the similarities between halal and kosher can also be analyzed to determine whether selected steps in the pharmaceutical production process can be reciprocally accepted under the different religious requirements. Opportunities Today, a quarter of the inhabitants of the world are Muslims. This figure is expected to grow by 35% over the next two decades, leaping from 1.6 billion to 2.2 billion by 2030 [2]. Even in markets where Muslims are a minority, when ranked by Gross Domestic Product at Purchasing Price Parity, large or developed nations, namely, the USA, Russia, UK, France, and Germany, are ranked among the top ten economies with Muslim buying power [3]. Driven by the potential lucrativeness of the industry, pharmaceutical giants, such as Novartis and GlaxoSmithKline, have attempted to come up with halal vaccines. With blockbuster drugs worth US$50 billion of market size going off patent this year [4], halal is an answer to raising the bottom line of the companies, because stringent halal certification processes once again set the companies apart. Traditional halal food regulatory authorities have also jumped at the opportunity, with countries such as Malaysia publishing their own halal standards [5]. The uniqueness of this standard is that it rides on the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), whereby the product has to first and foremost be certified to comply with safety, quality, and efficacy requirements under PIC/S standards before it can be certified halal. This would also demystify the notion that halal products are of lower quality. Challenges For the industry to thrive, there are challenges that need to be met to achieve a drug that is recognized by all Muslims as halal, and by non-Muslims as equal or superior quality. The major challenge is perhaps the need to put in place a wellregulated and harmonized accreditation and halal management system that is globally accepted. A good example is the antimeningococcal conjugated vaccine that has been certified halal by the Indonesian halal certification authority (http//www.id.novartis.com/news-detail-vc2010.html) but not by its Malaysian counterpart. In certifying products to be halal, certification bodies should comprise professionals (Muslims and non-Muslims) who are experts in both religious jurisprudence and science and technology. In fact, this approach is already being adopted by the Malaysian and Indonesian authorities. However, the technical capacity of Trends in Pharmacological Sciences xx (2015) 1–2
1
TIPS-1250; No. of Pages 2
Forum these regulatory agencies would need to be continually enhanced and harmonized to meet the anticipated increase in applications for halal drug approvals. This would enable reciprocal recognition by the various halal certification authorities for halal pharmaceuticals similar to the current practise for halal food and beverages. As the different types of production process within the pharmaceutical production chain seek certification, different types of question peculiar to each niche process are bound to crop up. Therefore, experts in specific production processes and drug development are needed to answer these questions. Other steps to strengthen the certification process may include introducing tests for DNA and protein sources, and publishing the list of halal pharmaceutical sources based on the available pharmacopoeia, to name but a few. In getting global recognition for halal, advocacy is needed to educate consumers that halal drugs are of a quality as high as, if not higher than, their non-halal counterparts. In halal branding, consumers, Muslim and non-Muslims alike, have to see halal products as wholesome, encompassing alternatives that do not compromise fundamental drug standards. Concluding remarks In the halal food industry, developed nations with minority Muslim populations are one of the biggest producers of halal products: Australia being a halal beef producer, New Zealand a halal lamb producer, and Brazil, a halal chicken
2
Trends in Pharmacological Sciences xxx xxxx, Vol. xxx, No. x
producer. For the new market entrant into the pharmaceutical industry, whether they be a majority or minority Muslim country, it is logical to enter the market on a halal platform, because the foundation will be built on a differentiated global business model with added competitive advantage. To cater to the certification of this expanding industry, more efforts are needed to institute training of religious authorities on science and technology, as well as training scientific experts in basic religious requirements, and the development of scientific methods and literature to support the industry so that halal pharmaceuticals can enter the global market as smoothly as possible. Acknowledgments The authors would like to acknowledge the Apex Special Grant, Universiti Sains Malaysia for supporting their work on halal vaccine development. M.N.N. is a Fellow of the Academy of Sciences, Malaysia.
References 1 Halim, M.A.A. and Salleh, M.M.M. (2012) The possibility of uniformity on halal standards in Organization of Islamic Countries (OIC) country. World Appl. Sci. J. 17, 6–10 2 Pew Research Center (2011) The Future of the Global Muslim Population, Pew Research Center 3 Hunter, M. (2012) The emerging halal cosmetic and personal care market. Personal Care Mar. 2012, 34–39 4 Bloomberg Business (2013) Big Pharma’s Pa-tent Cliff, Bloomberg Business 5 Department of Standards Malaysia (2012) Halal Pharmaceuticals: General Guidelines, Department of Standards Malaysia
