On Halal Drugs and Vaccines: Safety Should Come First
The Padang, West Sumatra administration declared an extraordinary situation in February following an outbreak of diphtheria. A total of 62 people were suspected of being infected with the disease, one of them died. The outbreak, the first to have occurred in the province, prompted the local government to repeat diphtheria immunization to prevent the disease from spreading even further.

The outbreak in Padang was not the only incidence to have occurred in Indonesia due to incomplete immunization or a lack of it. Three disease outbreaks have been reported to have affected Indonesian children.

In the period 2005-2006, a polio outbreak hit Sukabumi and, to a lesser degree, Madura, affecting nearly 351 children, 305 of them became paralyzed for good. The second incidence was a diphtheria outbreak in East Java (2009-2011), which caused more than 1,200 children to be hospitalized, 120 of them ended dead. The third incidence occurred in Central Java and West Java (2009-2011) when an outbreak of measles affected 5,000 children, killing 16 of them.

"It turned out that 30 percent of them did not receive immunization and 40 percent received incomplete immunication," said child development specialist Dr dr Soedjatmiko, SpA(K). (detik.com, 9 May 2015)

Data also show that in Indonesia, 1 infant (0-12 months old) dies every 35 minutes and one toddler (0-60 months) dies every 12 minutes. In fact, there are around 4.6-5.5 million births every year. Ignorance of the importance of immunization is blamed for the high death rate.

The high incidence of disabilities and deaths indicates a low public awareness of the importance of immunization. This is despite the fact that immunization has proven to have prevented diseases as far back as 1798, when the first vaccine, for smallpox, was administered. Polio, diphtheria, measles, tetanus, pertussis (whooping cough), and hepatitis B are among diseases that can be prevented by immunization.

One of the reasons behind public reluctance to have their children vaccinated is because people doubt the safety of the vaccines used. There is also the issue of halal, whether the vaccines are halal, said dr. Sri Rezeki S. Hadinegoro, the chairperson of the Indonesian Technical Advisory Group on Immunization (ITAGI) and a member of the Immunization Task Force of the Indonesian Pediatric Society. (Kompas, 5 March 2015) 

The halal status of drugs and vaccines is a major issue for Indonesians who are mostly muslim. The halal debate became even more heated after the House of Representatives passed the halal law in September 2014.

The law requires all business owners to obtain halal certificates for their products and put the halal label on their product packages. Those who fail to comply with the law will face administrative sanction. 

Not all vaccines contain ingredients that are considered haram by the teachings of Islam. Even if non-halal ingredients are used, they have undergone an extraction process to obtain the specific compound needed. The non-halal ingredients are not used in vaccines, said Health Minister Nila Djuwita Anfasa Moeloek. She said people should just consider the benefit of vaccines. Public rejection of vaccines because of the halal issue could have a huge negative effect such as in the case of the diphtheria outbreak in West Sumatra, where diphtheria immunization must be repeated. It cost a lot in terms of economic cost and deaths, which could have been prevented. The state must spend Rp15 billion to repeat the diphtheria immunization in West Sumatra for around 700,000 toddlers and children aged 7-10 years old. The amount did not include the operating costs incurred by the local administration. All in all, the total cost of the repeated immunization was around Rp30 billion.

In a workshop on halal law and its effect on access to vaccines and medicines and the threat to public health held on 4 June 2012 and 10 September 2012 by the Center for Health Economics and Policy Studies (Pusat Kajian Ekonomi dan Kebijakan Kesehatan), experts in pharmaceutics, public health, Islam and key stakeholders from various backgrounds, including the Religious Affairs Ministry, discussed in a comprehensive way the issue of halal and haram in drugs and vaccines. The speakers at the workshop were Hasbullah Thabrany, an expert in health policies and a professor at University of Indonesia’s Community Health Department who was also chairman of the organizing committee; Nasaruddin Umar, an expert in the interpretation of religious texts, professor at Universitas Islam Jakarta, and Deputy Religious Affairs Minister; Ali Gufron Mukti, an expert in health economics, professor of community health science at Gadjah Mada University’s School of Medicine, and Deputy Health Minister; Umar Anggara Jenie, an expert in medical chemistry and professor at Gadjah Mada University’s School of Pharmaceutics;  Dr. Lahouari Belgharbi, WHO scientist, Department of Vaccines Immunization and Biologicals (IVB), Quality Safety and Standards [QSS]; and Maura Linda Sitanggang, director general of pharmaceuticals and medical devices at the Ministry of Health. 

In general, the experts agreed that the issue of halal and haram in drugs and vaccines should be treated with extra caution by taking into consideration all the relevant factors because of their strategic aspect that could affect the world’s perception of Indonesia. Even more important is the fact that as it is a health matter that concerns the safety and security of the general public, the halal status of drugs and vaccines could directly affect all the other aspects of public life, including politics, economy, social affairs and education.

A regulation on drugs and vaccines that disregards public health concerns could lead to an outbreak of contagious diseases, which occured in Nigeria and Sudan, including diseases that are nearly eradicated worldwide such as poliomyelitis (polio). In fact, in 2005 Sukabumi declared an extraordinary situation due to an outbreak of acute placid paralysis and 15 of the 17 cases were confirmed to have been caused by the same polio virus strain that hit Saudi Arabia and Sudan. This was despite the fact that since 1995, Indonesia has been declared polio free. Sukabumi sends quite a large number of workers to Saudi Arabia and one of the few regions with a polio vaccination rate that is lower than the national agerage due to resistence from a small segment of its population. The outbreak was contained as the government moved  fast and administered polio vaccines to 5.2 million toddlers in West Java, Banten, and Jakarta.

According to the experts who joined the workshop, drugs and vaccines are different from other consumer goods because (a) they are consumed only in an emergency and (b) consumers actually do not want them--they are forced to consume the drugs and vaccines—and (c) they are consumed in moderation (based on the provision of the Al Baqarah, Verse 173).] 

They also agreed that it would be irresponsible for a country to make the halal status of drugs and vaccines an issue if it does not have the capacity or experience to produce drugs and vaccines of sufficient quantity for the entire world muslim population. This is especially true after members of the Organization of Islamic Cooperation (OIC), including  Saudi Arabia, accepted the 2005 fatwa (guideline) of the  Fiqh Council that the polio vaccine—and for that matter all drugs and vaccines contaminated with porcine—are halal. 

The workshop also revealed that at the international level, the controversy of the halal status of a drug—in this case vaccines that have been contaminated with porcine—started in 2007 when Indonesia and Malaysia attempted to promote the “halal vaccine concept” at the Conference of OIC Health Ministers in Kuala Lumpur. The concept was immediately rejected by Middle East countries, namely Saudi Arabia (the birthplace of Islam), Kuwait and Turkey. The delegations of the three countries put forward the following considerations: 

1. Do not confuse health issues with religious doctrine. 
2. It will very irresponsible for Indonesia and Malaysia to demand halal drugs and vaccines while neither has the capacity or experience to produce vaccines in sufficient quantity for the entire world muslim population.
3. The statement about “halal” vaccines will disrupt the effort of the Kingdom of Saudi Arabia to ensure the safety of all hajj pilgrims and will cause confusion related to the mandatory vaccination for people planning to go on the hajj pilgrimage.
4. The term halal vaccines will create a misunderstanding that all non-halal vaccines are not safe, and will greatly affect the immunization drive, and eventually, the health of the citizens of muslim countries and vaccine producers in other muslim countries.

Meanwhile, H.M. Hamdan Rasyid, a member of the Fatwa Council of the Indonesian Council of Ulama (MUI), said that Islam allows immunization, vaccines and vaccination to prevent diseases. If a vaccine is contaminated with haram ingredients, then it is haram to use that vaccine. However, if a halal vaccine is not yet available, the so-called haram vaccine may be used in an emergency, for example for people going on the hajj pilgrimage, he added.

The MUI also stressed that non-halal drugs may be used in an emergency when their halal substitutes have yet to be found.

On another occasion, International Pharmaceutical Manufactures Group (IPMG) Chairman Luthfi Mardiansyah said that IPMG maintains coordination with the Health Ministry, the National Agency of Drug and Food Control (BPOM) and related institutions to ensure that the implementation of the halal law does not disrupt public health service. 

“As in the case of vaccines, which are not yet classified as halal products. We don’t want to arrive at a stage when many pharmaceuticals cannot be sold,” he said. “Indonesia is the only country to have such a law, which will cause problems in the future,” he added. 

IPMG Executive Director Parulian Simanjuntak stressed that IPMG fully supports the spirit of the halal law, which seeks to protect consumers. However, he warned that the law will be difficult to apply to the pharmaceutical industry because pharmaceutical raw materials come from various sources. According to IPMG Chairman Luthfi Mardiansyah, 90 percent of the raw materials used by the pharmaceutical industry in Indonesia are imported. Therefore, it will be very difficult for the government to audit the procedure related to the halal status of their products because that means the government must go to each country that produces the raw materials, Parulian added.

Therefore, Parulian proposed that the government revise the halal law to exempt the pharmaceutical industry from the requirement to have halal certificates for their products. Otherwise, pharmaceutical companies will stop producing drugs in Indonesia for fear of the sanction against violators of the halal law. This will affect drug supply in Indonesia, said Parulian.

Rather than allowing the seemingly endless debate on the matter to continue, the government should encourage research to produce substitutes for the so-called non-halal drugs and vaccines by providing incentives for pharmaceutical companies. That way, they can no longer  “hide” behind the “emergency” situation as alleged.

As long as halal pharmaceutical raw materials are not yet available, the so-called haram drugs and vaccines may be used in an emergency as stipulated by the MUI, to ensure public health for which drugs and vaccines are made.



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