Halal Biopharma: Closing the Therapeutic Gaps

Dr. Israfil Merican, MD, MHM, Vice President - Head of Biopharma and Patient Access, Pharmaniaga Berhad

Dr. Israfil Merican is the Head of Medical Affairs for Pharmaniaga Research Center, a subsidiary of Pharmaniaga Berhad, a GLC based in Malaysia. He has Master of Health Management and has spent almost 15 years in various sectors of healthcare – public hospitals, medical travel, biopharmaceutical, diagnostics and digital health.

Introduction

In the realm of medical practice, the pursuit of saving lives stands as the foremost mission for healthcare professionals, regardless of their personal beliefs.

Healthcare professionals understand the importance of prescribing the most effective medications in curing dangerous disorders even during emergency (darurah) situations. When a person's life is at immediate risk and there are no permissible alternatives available, Islamic principles allow for the use of haram (forbidden) medicine as a last resort. While consuming haram substances is generally discouraged in Islam, the preservation of life takes precedence in situations of necessity or emergencies.The use of haram medicine during emergencies should be considered a last resort, taken only when there are no permissible alternatives available, and after consulting with relevant experts and religious authorities.

However, when it comes to preventive measures such as vaccinations or prevention of venous thromboembolisms (VTE) in pregnant women, there is an increasing trend among patients - vaccine hesitancy and discontinuing the anti-coagulants particularly due to concerns about non-halal ingredients. Despite receiving medical explanations from healthcare professionals and being given alternatives that are acceptable in accordance with religious authorities, patients are reluctant to accept these medications because there are no immediate life-threatening situations. It is crucial to address these concerns and provide accurate information to help individuals make informed decisions about their health and the health of their unborn child.

This is clearly the therapeutic gap, in which the lack of 'halal' medicines may jeopardize public health initiatives (vaccinations), as well as improvements in safe motherhood, amongst other healthcare challenges. With the growing concern, who should be in charge of conducting research, developing, and manufacturing halal medicines?

Proposal

Access to Halal healthcare is based on the principle that Muslims should have access to healthcare and medication that are compatible with their religious beliefs and practices. It seeks to address the therapeutic gaps by providing halal-certified alternatives for various medical treatments, including medications, vaccines, and medical procedures. To achieve this, the local industry players, healthcare professionals and the government should be working together in the best interests of our main stakeholders, patients, and the public to made available halal medicines and vaccines for patients. Listening and understanding their wants and needs will improve acceptance and adherence towards recommended medical interventions and consequently reduce diseases burden, mortality, and morbidity. This is the way forward for better healthcare outcomes.

Clinical trials are an essential part of the development of new medicines including halal biosimilars. Halal status for an alternative medicine is insufficient as healthcare professionals hold dearly the evidence-based medicines in their practices

Mutual understanding of halal requirements and seamless collaboration with our supply chain partners is vital. Identifying international partners that have alternatives to porcine based medicines is the most important first step. This is not just a simple replacement of substances but also requires the sourcing process of the raw materials, purification and development processes to produce the finished goods to comply with the standard Halal requirements.

“At Pharmaniaga, we are committed to becoming the leading halal biopharma company in Malaysia and the regions focusing on vaccines, insulin, and anti-coagulants. We have made this our priority with the investment in establishing the world’s first halal biopharma manufacturing and EU certified plant in Malaysia since 2013”.

Within biosimilar product research and developments, different activities including analytical characterization, preclinical studies and clinical trials which accounts for more than half of R&D budget and timelines need to be completed prior to the final approval. In general, this can cost between USD 100 million to USD 300 million.

Challenges

R&D Cost

In addition to the relatively high cost of R&D (for small & mid-size biopharma companies), the success rate for developing new biosimilars remains relatively low. Support from relevant government agencies in the form of R&D grants would be crucial to ensure the success of products development. Especially when the product pipelines are aligned with the public health initiatives by the government, such as the National Immunization Program.

Healthcare Professionals Trust

Halal Accreditation

Different countries have different standards of Halal accreditation requirements due different ‘mazhabs’ - schools of thought within fiqh (Islamic jurisprudence).One country will give one product a halal status where else the other country might not give the same Halal status. Closer engagement between the industry players and the authority is important to align the R&D process and halal status requirements. Next, regional, or global standardisation is very important to ensure faster access to different Muslim majority markets and bring confidence for acceptance by the populations.

Patient Access

Another form of support that would be key for the long-term success is a guaranteed purchase from the government with a strong public healthcare system, ensuring immediate patient access to halal medicines. The increase in demands from public healthcare facilities will shape the private market demand and drive the local halal biopharma companies to invest in expansion and new innovations. Thus, ensuring vaccine security and sustainable supply of other Halal biosimilars for the country. Consequently, this can allow access towards affordable halal biopharma products for the country and other international Muslim population.

Conclusion

In healthcare ecosystems, patients are at the center of care. Understanding patients’ journey and identifying the pain points at each milestone will help us to provide better solutions and outcomes. Halal biopharma is an opportunity to achieve the intended healthcare outcomes and requires continuous collaboration and supports from the government authorities, industry players, halal experts, healthcare professionals, and payers to deliver halal and medicine and finally close the therapeutic gaps in the long term.