PhAMA currently has five Committees who are committed to a shared cause of increasing access to innovator medicines. Within these Committees, Taskforces are formed to work on projects. While most committees function independently, some projects cut across different committees, which results in cross-functional taskforces. 

To maintain inclusiveness, neutrality and fairness to all member companies, all Committee and Taskforce members are to be appointed by the Country Head/ General Manager/ CEO/ Country President.

Committee member: 1 representative from each member company in each committee (with the exception of Regulatory Affairs and Ethics, where 2 representatives are permitted). 

Taskforce member: TF members are typically subject matter experts, and may or may not be members of a committee. 

 

1) Policy & Intellectual Property Rights (IPR)

Committee members create opportunities for dialogue and engagement with government, government-related agencies and key stakeholders towards policy-shaping and nation-building, at the same time advocate for the strengthening of Intellectual Property Rights to support Malaysia in becoming a Knowledge-Based Economy.

Taskforces:

  • Annual Budget Recommendations
  • Health Financing
  • Patent Linkage
  • Animal DNA Testing Alternatives
  • Dasar Ubat Negara (National Medicine Policy)

 

2) Market Access & Procurement

Committee members identify and resolve obstacles in access to innovative medicines to enable wider access to the best-in-class medicines towards the goal of Universal Health Coverage. This includes enhancing the process of Formulary Listing, Public Procurement, Health Financing, Health Economics and more.

Taskforces:

  • Health Technology Assessment (HTA)
  • MOH National Drug Formulary
  • Medicine Access Schemes (MASc)

 

3) Regulatory Affairs

Committee members work closely with the National Pharmaceutical Regulatory Authority (NPRA) and Pharmacy Services Programme within the Ministry of Health to promote high regulatory standards and a robust environment that facilitates efficient registration of medicines and New Chemical Compounds in the country.

Taskforces:

  • E-labelling
  • APAC RAEWG
  • APAC e-Labelling EWG
  • APRIA
  • Reliance (Alternative pathways & Collaborative Platforms)
  • Track & Trace 
  • Pharmacovigilance

 

4) Clinical Research

The committee is dedicated to driving clinical research initiatives in Malaysia by working with external stakeholders such as Clinical Research Malaysia (CRM), Institute of Clinical Research (ICR), Clinical Research Organisations and more, towards making Malaysia a preferred hub for clinical research in the region.

Taskforces:

  • Protégé Programme
  • Public awareness programmes

 

5) Ethics & Compliance

Committee members comprising commercial (client-facing) and non-commercial (medical, compliance, legal) personnel develop, maintain and enforce high ethical standards for industry players through the PhAMA Code of Practice using principle-based and risk-based approaches. 

Taskforces:

  • Code of Practice workshop
  • Code of Practice Review

 

 

 

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