SUSTAINABLE access to innovative health care and continued advancement in research and development of innovative biopharmaceuticals are critical components for economic growth in the European Union (EU) and Asean (and the Philippines!). Asean leaders identified health care as one of the 12 priority sectors to help drive Asean integration and creation of the Asean Economic Community. Asean health ministers have also emphasized that health development is a shared responsibility and must involve greater participation from all groups. EU business commends this commitment for collaboration among governments and the private sector.
The EU biopharmaceutical industry supports Asean and its member- countries’ trade, health and regulatory reforms that promote the free flow, of goods for consumers, and ensures quality, efficacy and safety of pharmaceuticals. However, challenges exist.
Patient safety and producing quality medicines are the foundations of the EU pharmaceutical industry, but necessary, burdensome, or inconsistent regulations impede or delay access to medicines in Asean member-states.
Market-access restrictions in the form of preferential procurement and procedures affect the ability of bring innovative products to market.
Inadequate intellectual-property protection and enforcement have a detrimental impact on the availability of safe medicines, and create potential health hazards to consumers.
The EU pharmaceutical industry will continue to support the ongoing reforms, and act as a partner of local and regional health authorities to deliver on their health-care goals.
The pharmaceutical industry in most Asean markets is growing and dynamic, albeit at variant rates. The growth is driven by several factors, including the emergence of more efficient health systems that are expanding access for consumers (such as universal health in the Philippines). Both innovative and generic pharmaceutical sectors are benefiting from this growth.
In 2016 the Asean Economic Community started its integration, and will be a driver on expanding health-care services and goods throughout Asean with more partnerships forming, and greater collaboration on research and development being encouraged. The EU pharmaceutical sector stands ready to be collaborative partner. The EU bilateral free-trade agreements with certain Asean markets have the potential to be the most significant driver for opening the markets and benefiting Asean and EU companies.
Key issues are:
- Patient safety
- Clarification of laws
- Clinical trials
- Regulatory delays
- Parallel trade
- Labeling standards
Market access:
- Foreign direct investments
- Government procurement
- Preferential treatment for state-owned enterprises
- Intellectual property
- Patents
- Regulatory data protection
- Counterfeit medicines
Key recommendations:
- The EU pharmaceutical industry recommends greater and more frequent private-sector consultation in advance of the development of domestic regulations, and that private-sector issues be more frequently addressed at the Asean level.
- The industry recommends clear and transparent procurement or listing procedures for biopharmaceuticals that recognize the value of innovation, rather than create disincentives for access to innovative medicines.
- The EU pharma industry urges Asean governments to prioritize IPR protection and develop initiatives to reduce the delays and backlogs that exist in granting patents.
- The industry recommends greater interministerial coordination at the Asean and domestic level so that trade, health, economic matters can be effectively and cohesively addressed.
- The EU pharmaceutical industry recognizes that Asean member- countries take the threat of counterfeit and substandard medicine seriously, and recommend greater collaboration among all health-care stakeholders be developed regionally to address this growing cross-border issue and promote awareness among consumers.