Overview of Hong Kong
The healthcare system of Hong Kong runs on a dual-track basis encompassing the public and the private sectors. The public system is guided by the Hospital Authority (HA) and is organized into seven clusters serving the entire population of Hong Kong with subsidized medical care. The private hospital system, loosely associated within the Hong Kong Private Hospital Association, includes 12 private hospitals1. For the past several years, Hong Kong’s government budget for medical health services has increased year-to-year. In 2018-19, the budget has allocated additional recurrent funding of nearly HK$6 billion to Hospital Authority and set aside HK$500 million to support the improvement of patient’s co-payment mechanism for purchasing drugs2.
As of 2018, Hong Kong has a population of 7.3 million and an annual GDP per capital of US$36,2003. The total health expenditure has witnessed a steady growth since 2008, rising from HK$93.7 billion in the year ended March 2009 to HK$112.1 billion in the year ended March 2013, representing a compound annual growth rate (CAGR) of 7.6% during this period. The total health expenditure is expected to reach HK$176.5 billion in the year ending March 2020. Health expenditure is expected to continue to represent approximately 5% of GDP4.
Currently in Hong Kong there are significant implications of population ageing, added with communicable diseases and government attention on enhancing healthcare system and improving access to medicines. These lead to a dominating Western medicine segment in the Hong Kong pharmaceutical market with a 90.0% in revenue. Contributing to the Western medicine segment are OTC, generic and patented drugs: OTC drugs are drugs that are generally purchased over-the-counter without a prescription; generic drugs and patented drugs are primarily prescribed by doctors.
In Hong Kong, the Department of Health is the sole government body who is responsible for evaluating and overseeing the safety, efficacy and quality of all pharmaceutical medicines marketed in the country. All medicines are required to be registered under the Pharmacy and Poisons Ordinance Chapter 138 (Cap 138).
Regulating under Cap 138, criteria for pharmaceutical registration involves safety, efficacy and quality of the product drug. The following documents are considered as mandatory documents for a pharmaceutical registration application: cover letter, a copy of business registration certificate, , authorization letter from manufacturer, manufacturer’s license, site master file, PIC/S GMP certificate, free sale certificate from the country of origin, master formula, finished product specification, stability data, prototype sales pack and proposed package insert.
The process of pharmaceutical registration involves evaluation by the pharmaceutical registration committee and the Pharmacy and Poison Board. This stage usually can take up to nine months from the date of submission of the application. Further steps are required for new chemical entity registration which involve law drafting, legislation vetting and gazette that can take up to twelve months or even more.
Approved pharmaceutical products are grouped into three main categories based on the severity of the diseases they intend for and the magnitude of the side effects they cause7:
Category 1 – “Prescription Drugs” used to treat serious diseases. Incorrect dosage or improper use could result in serious health damage. These medicines require a doctor’s prescription to be dispensed and sold in registered pharmacies under the direct supervision of registered pharmacists.
Category 2 – “Drugs Under Supervised Sales”. Incorrect dosage or improper use could cause health risks. These medicines must be sold in registered pharmacies under the supervision of registered pharmacists, but do not require a doctor’s prescription.
Category 3 – Drugs used to treat or alleviate minor illnesses, with few side effects. Incorrect dosage or improper use could still result in undesirable side effects. These medicines can be sold in pharmacies or stores without resident pharmacists.
According to the Pharmacy and Poisons Ordinance, all new drugs must undergo rigorous assessment by the Pharmacy and Poisons Board before they can be sold, distributed or possessed for the purpose of sales in Hong Kong. Unregistered product marketed found to contain substances that fall into the identification of a pharmaceutical product, a maximum penalty for an offence is a fine of HK$100,000 and two years of imprisonment6.
Hong Kong Healthcare Bodies
