BioSpectrum – Regulatory Challenges For APAC Businesses – Biotech in Asia Pacific

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By 2020, according to Frost & Sullivan, healthcare expenditure in the APAC will increase 151 percent over 2010 figure, to $2927 billion at a compound annual growth rate of 9.2 percent.

Factors such as increasing population, per capita income, prevalence of lifestyle diseases due to rapid urbanization, apart from cost factors, are aiding growth. However, the opportunities come with a set of challenges, some of which are unique to the region. The APAC is characterized by diverse therapeutic segments, different and complex regulatory laws and a fragmented market, and the global economic crisis has added a new layer of complexity to the already challenging environment.

Originally published here.

BioSpectrum identifies 10 challenges that are common to the region and are likely to be hurdles in the industry’s progress. Cultural Diversity Critical Mass Policy Issues Raising Capital Human Resouces Regulatory Issues Currency Fluctuation Partnering Price Sensitivity Credible “midsize” CROs.

Regulatory challenges in APAC include a major challenge in India of having an effective mechanism for dealing with the government, given its active responsibility in taking funding decisions, regulating healthcare services, and deciding policy issues, including the most crucial ones regarding intellectual property rights. “In China, companies need to pass many hurdles such as complicated regulatory framework and a lengthy process for getting a product registered and then getting it added to the national reimbursement list,” he adds. In Australia, he says, the challenge for pharmaceutical companies “is the upcoming patent expiration for drugs developed in the 1980s and replicating those profit streams”.

More about regulatory challenges in APAC can be read here.

Full Article can be read here10 challenges for businesses in APAC

Rahul Dev, Partner at the law firm of Tech Corp Legal LLP, is a patent attorney and international technology business lawyer. Dev’s corporate law practice is aimed at integrating patents, technology laws, intellectual property rights, regulatory and security laws to provide services to FinTech companies.

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