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Balancing Intelectual Property Protection and Legal Risk Assessment in Registration of Covid-19 Vaccines in Malaysia

Ahamat H, Sa'ban H, Manap NA

Health Care Anal, 2023 Dec;31(3-4):196-207.
PMID: 37477838 DOI: 10.1007/s10728-023-00465-9

The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area.
Occupational radiation exposure to anesthetists from fluoroscopic projections during orthopedic operative procedures

Abas AA, Rahman RA, Yahya N, Kamaruzaman E, Zainuddin K, Manap NA

Clin Ter, 2014;165(4):e253-7.
PMID: 25203339 DOI: 10.7417/CT.2014.1739

The role of anesthetists during orthopedic fluoroscopic procedures exposes them to radiation. We conducted a prospective, descriptive study to estimate the radiation exposure to anesthetists during procedures over a six-month period in the orthopedic trauma operating theatres which had the most fluoroscopic usage.
A solution towards a viable compensation mechanism for injury from COVID-19 vaccines in Malaysia: A qualitative study

Mokhtar FS, Ariff AM, Manap NA, Mustaffa NM

Heliyon, 2024 Feb 15;10(3):e25204.
PMID: 38333837 DOI: 10.1016/j.heliyon.2024.e25204

BACKGROUND: It has been established that the existing compensation mechanism is not the favoured platform for vaccine recipients with Adverse Effects Following Immunisation (AEFI). With the mass production of vaccines during the COVID-19 pandemic, intensified by the mandatory National COVID-19 Immunisation Programme in Malaysia, an alternative resolution mechanism for compensation is long overdue. This qualitative study aims to propose a viable alternative dispute resolution (ADR) mechanism for those who suffer AEFI from COVID-19 vaccination, particularly the economically disadvantaged, older people, and disabled individuals in Malaysia.
METHODS: The researchers conducted an in-depth focus group discussion in September 2022 involving seven participants representing key stakeholders in vaccine compensations from governmental agencies, non-governmental organisations (NGOs), and private institutions who were experts in litigation and legislation, consumer protection, and medical practices in Malaysia. The study utilised ATLAS.ti 22 to conduct a thematic analysis.
FINDINGS: The analysis yielded three themes: existing mechanisms and their challenges, the role of ADR, and the solution for a vaccine injury compensation mechanism. The participants shared their knowledge and experience regarding the existing vaccine compensation mechanisms in Malaysia, i.e. the common law of Tort and Consumer Protection Act 1999, and explained how each mechanism relates to specific challenges or arguments that provide the basis on which they are unable to accord fair compensation to the vaccine recipients. The participants debated the merits and disadvantages of the types of ADR for AEFI and unanimously proposed a specific healthcare centre for compensation (SHCC) as the most viable compensation mechanism for AEFI.
CONCLUSION: SHCC offers a new ADR to serve as a compensation mechanism for claimants affected by the COVID-19 vaccines while also contributing to achieving Sustainable Development Goal 16: peace, justice, and strong institutions.
Fulltext Effect of an Education Programme on Cardiovascular Health Index among Patients with Myocardial Infarction: A Preliminary Study

Manap NA, Sharoni SKA, Rahman PA, Majid HAMA

Malays J Med Sci, 2018 Mar;25(2):105-115.
PMID: 30918460 MyJurnal DOI: 10.21315/mjms2018.25.2.11

Introduction: Health education is an essential part of controlling the risk of myocardial infarction (MI). This study evaluates the effects of one-on-one education programmes on the cardiovascular health index among patients with MI.
Methods: A quasi-experimental study was conducted in Kuala Lumpur Hospital, Malaysia. Data were collected from November 2014 to January 2015 with a total of 58 respondents who met the inclusion criteria. The respondents received a 20-min one-on-one education programme regarding coronary heart disease, treatment and prevention, and healthy lifestyle. A questionnaire comprising demographic data was administered and the cardiovascular health index was measured before and after four weeks of the education programme. Data were analysed with descriptive and inferential statistics.
Results: There were statistically significant decreases in the score of anxiety, stress, depression, body mass index, and smoking status (P < 0.001) between pre-test and post-test.
Conclusion: The findings suggest that the one-on-one education programme could improve the cardiovascular health index of patients with MI. Furthermore, nurses need to develop and implement a standard education structure programme for patients with MI to improve health outcomes.