Would ASEAN Accept Data and Reviews that Cross Borders?

Robert Lim, Head of Haematology and Oncology, for the National University Cancer Institute, speaks exclusively to Bryan Camoens from Pharma IQ, on the fundamental difference between pharmacodiligence and pharmacovigilance.

Pharma IQ: What are the unique risks and challenges to pharmacovigilance and drug safety faced by pharmaceutical companies in Asia?

R Lim: Receiving timely and accurate data. Asia is a diverse place, where many countries are hovering at different levels, including issues such as differing health care infrastructure. This would make it difficult to ensure consistency in reporting. There is the potential that some might not even honour patents on drugs, so there will be difficulty in comprehending reports on side effects of different preparations.

Distance to major hospitals can be great, making it difficult to access experts for assessing adverse events and causality. This would have an impact on data collection and potentially leads to less precise data (e.g. understanding the denominator of how much is prescribed vs. how many events.)

Furthermore, given how important pharmacogenetics has become in understanding drug handling issues, this is further compounded by the lack of accompanying data that could help our understanding and in identifying potential risks. Asia consists of different countries with different regulatory systems, different laws, and differing levels of sophistication, development and also vastly different political systems.

Pharma IQ: Asia lacks a harmonised regulatory system for pharmacovigilance and drug safety. The Association of Southeast Asian Nations (ASEAN) has taken the first step to build an integrated pharmaceutical sector. What about the rest of Asia? How long do you think it will take and what challenges do you foresee in creating an EMEA equivalent in Asia?

R Lim:  For reasons such as above, forming such an equivalent system in Asia is fraught with challenges. A certain political will and mindset would be of priority as would the agreement of all stakeholders. As usual, issues like infrastructure and costs then have to be factored in. ASEAN can try to work together in the pharmaceutical sector, but would it accept data and reviews that cross borders? Hopefully, looking at the broader context of Asia, one can postulate that there will be disagreements, different levels of expertise, and differing levels of motivation. It will likely take a long time. The way healthcare is delivered matters too - in the EU this is predominantly socialist - therefore government pays. Hence governments in that region can mandate the collection of data. In Asia, healthcare is still predominantly paid for by the patient (some exceptions do exist in certain government hospitals). Data collection in this setting would be difficult.

Pharma IQ: What steps can pharmaceutical companies and regulatory authorities take to create a comprehensive Pharmacovigilance system to serve the safety of Asian patients?

R Lim: Ease of use, accessible, standardised formats. In addition, harness IT. There also has to be not only agreement on the aims, methods and ownership of this, but also trust in each other that the ultimate goal of achieving the system will be of benefit to all.

Pharma IQ:  In your view, what is the fundamental difference between pharmacodiligence or pharmacovigilance?

R Lim: Pharmacodiligence would lay the greater emphasis on data collection and less so on the risk assessments and management of the data. The converse would be true of pharmacovigilance. An essential aim of a system to track and alert us to drug safety issues, is to achieve prompt warnings of emerging trends in drug related adverse effects. The ultimate goal here is increasing patient safety. In this regard, one might argue that the management of data (albeit with constraints of the quality of the data being inherent) is of greater importance.

Pharma IQ: What are the challenges to safety data collection and signal detection systems, considering the complex ethnicity of Asian population? What can be done to improve the situation?

R Lim: Create greater awareness and recognition by healthcare workers and patients of the importance and need to report events. Perhaps consider the issue of examining pharmacogenetics though this would require the banking of DNA/tissue for eventual study. This issue is fraught with tremendous concerns, ranging from confidentiality, data ownership, patents arising, local laws, sensitivities and ethics.

It may be important to perhaps consider geographical reporting than ethnic based reporting. What ever it is, the system must be able to pick up increased toxicities in certain geogrpahical areas compared to the norm. Integrating the ethnicity issue follows that., ethnicity itself might be less pertinent in the longer run.

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Pharma IQ: What can be done to combat drug counterfeiting and to minimise the impact of substandard pharmaceuticals on drug safey and pharmacovigilance in Asia?

R Lim: Improving access to the patented drugs, which are often costly and thus beyond the reach of many patients. Counterfeiting exists in part due to the relative inaccessibility of these drugs, especially due to the costs. This is a complicated issue which in part involves the parent pharmaceuticals being part of the solution as well.

Pharma IQ: How do you see pharmacovigilance evolving over the by the year 2020?

R Lim: I think there should be a forum of the equivalents of MOH and HSA of all interested Asian countries to meet and work together to harmonise and compare notes on drug regulation, including adverse event reporting, the methods employed in collecting accurate data and measuring or tracking patient outcome. It would be ideal to also collect genetic data if possible. The next level would have major pharma engage and talk with these regulatory authorities. Other ways may be to set this up as a not-for profit organisation, that works across borders to collect data from different countries. However, this again requires the will and consensus from all concerned.