Pharmaceutical Industry

Sustainable access to innovative healthcare and continued advancement in research and development of innovative biopharmaceuticals are critical components for economic growth in the EU and ASEAN.

ASEAN leaders identified healthcare 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 is the foundation 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 unclear foreign ownership laws, and preferential procurement and listing 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 healthcare 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. Both innovative and generic pharmaceutical sectors are benefiting from this growth.

In 2016 the AEC will begin its integration, and will be a driver on expanding healthcare 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 FTA’s with certain ASEAN markets (the Philippines lagging behind) 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 that ASEAN and member countries liberalize foreign ownership laws so there is a consistency with WTO obligations, and that EU companies are able to compete equally with ASEAN domestic companies.

• 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 inter-ministerial 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 healthcare stakeholders be developed regionally to address this growing cross-border issue and promote awareness among consumers. [email protected]