ASEAN Countries will Lead Asian Pharmacovigilance Harmonisation
Dr. Suzette H. Lazo, Director of the Philippines’ Food & Drug Administration, believes that Asia can see harmonised, EMEA equivalent pharmacovigilance system in Asia in the next decade, if there is strong leadership from stakeholders including governments, and pharma companies. Lazo emphasised the need to separate politics from scientific affairs, and believes that ASEAN could take a leadership role in harmonising PV across Asia in this exclusive interview with Pharma IQ’s Divya Sangam.
Pharma IQ: What are the unique risks and challenges to pharmacovigilance and drug safety faced by pharmaceutical companies in Asia?
S Lazo: There is variation in laws, health care systems, attitudes and level of technical sophistication among countries in Asia. Legal issues still predominate as a deterrent to reporting in some countries with resultant underreporting. There is also the prevailing notion that drugs in the market are 100% safe and the realities of risk to benefit decisions are still beyond the perception of the public; a culture of finger-pointing and blame-finding still exist. Poor regulatory understanding of PV, pressure from politics, media and even the public hamper the development of a well-functioning national pharmacovigilance system. Not all pharmaceutical companies appreciate the importance of pharmacovigilance and may regard it as an isolated activity that belongs only to a small department within a pharma company.
In reality, PV is an integrated discipline that cuts across almost all departments of the company. The high profile safety issues related to some products have created greater regulatory enforcement with greater accountability of pharmaceutical companies on the protection of the public. Rapidly developing new disciplines such as pharmacogenomics and the advent of personalised medicines and interchangeability issues of biosimilars require new approaches for both regulatory and industry.
Pharma IQ: What kinds of solutions will be applicable to address the above mentioned challenges?
S Lazo: Education, advocacy, regulatory reforms. Setting up a legislative framework is important. Policies should be put in place to promote transparency in the pharma industry to address issues like risk benefit management and communications.
Pharma IQ: How long do you think it will take to create a harmonised regulatory system in Asia, and what challenges do you foresee in creating an EMEA equivalent in Asia?
S Lazo: With strong leadership from one or two ASEAN countries, it could be successful. WHO support will also be key, but there is a need to dissociate politics from scientific regulatory work.
Pharma IQ: What steps can pharmaceutical companies and regulatory authorities take to create a comprehensive pharmacovigilance system to serve the safety of Asian patients?
S Lazo: First, there must be trust and professionalism. Building on the experience of the different countries to integrate which systems work and assessing usefulness to benefit all.
Pharma IQ: What can be done to combat drug counterfeiting and to minimise the impact of substandard pharmaceuticals on drug safety and pharmacovigilance in Asia?
S Lazo: Reforms that will address regulatory capture, political will and backing, punishment of errant groups consistently and without favoritism and sharing information and learning on actual cases of detection and closures and prosecution.
Pharma IQ: Where do you see pharmacovigilance in Asia by the year 2020?
S Lazo: With strong leadership, harmonisation may be attained in a decade from now.
Pharma IQ: A number of people define PV in Asia as strictly post-market. Do you think is the case? Why?
S Lazo: This is a very limited view of PV which should in fact, cover public health, due diligence in manufacturing, transporting and testing drug products before it even gets out into the market. Earlier stages of clinical trials will also need drug safety monitoring.
I believe that PV extends beyond PMS and covers risk management and risk communications. PV is also concerned about medication errors that are nonintentional and seek solutions to prevent such from happening repeatedly. PV also addresses detection of counterfeit medicines.