Philippines Pharmaceutical Updates

Introduction:

The Philippines pharmaceutical market is growing rapidly. It is heavily driven by imports and is currently the third largest market in ASEAN after Indonesia and Thailand. The Philippines pharmaceutical market, currently valued at about $3.0 billion, is predicated to reach about $3.4 billion by 2013 according to experts. The body for Philippines pharmaceutical regulations, the Bureau of Food and Drug (BFAD), adopted US Pharmacopoeia standards. Hence, US pharmaceuticals should continue to have good market potential. The majority of pharmaceutical sales in the country are from prescription drugs. Over the past five years, there has been an increase in the number of both local and foreign drug companies. Currently, the biggest pharmaceutical companies in the Philippines include Novartis, Sanofi-Aventis Philippines, Wyeth, Abbott, Pfizer, and Johnson & Johnson.

In an effort to grant citizens more access to essential drugs, the government passed the “Cheaper Medicines Act of 2008”. This legislation gave power to the President, upon recommendation of the Health Secretary, to impose a maximum retail price (MRP) over any or all drugs enumerated in the Philippine Essential Drug List. However, despite various government policies, drug prices in the Philippines are some of the highest in Asia.

Pharmaceutical Regulatory Information:

The BFAD is the main body for Philippines pharmaceutical regulations. The BFAD handles the registration of processed food, drugs, medical devices, in-vitro diagnostic reagents, cosmetics, and household hazardous substance products.

For companies that want to know whether their product falls under the food, drug, or cosmetic category, they may apply for product classification. Application documents with sample and complete product information and proof of payment can be submitted to the Policy, Planning, and Advocacy Division of the BFAD.

Companies involved in the manufacture, packaging, re-packaging, importation, exportation, distribution, and retailing of processed foods, drugs, medical devices, in-vitro diagnostic reagents, cosmetics, and household hazardous substance products must secure a License to Operate (LTO) from the BFAD before applying for pharmaceutical product registration in the Phillippines.

Philippines pharmaceutical regulations may require the following documents for the product registration:

  • an Application for Registration of Pharmaceutical form,
  • a valid License to Operate from the manufacturer/distributor/importer,
  • labeling materials,
  • product sample,
  • product formulation and dosage, etc.

In The News:

According to news reports, the demand for medicines in the Philippines is expected to increase 17% yearly. The majority of the demand will be met through out-of-pocket expenses, rather than through government insurance funding or subsidies. Top causes of mortality include respiratory and cardiovascular diseases, which are reflected in the strong demand for drugs in these categories. The Philippines government has promised to expand the Philippine Health Insurance (PhilHealth) to all citizens by 2013. However, studies show the Philippines is lagging behind in making medicines more accessible to the poor.

Hepatitis B:

In July 2011, the Filipino subsidiary of pharmaceutical giant Roche Inc. along with the Hepatology Society of the Philippines have launched a new program to help hepatitis B patients gain access to treatment at discounted rates. The “PEGASSIST Easy Access Plan” allows patients to access peg-itnerferon alfa-2a hepatitis treatment medication with discounts up to about 50%. In addition, hepatitis B patients can have free access to selected laboratory tests that would otherwise be very expensive. Patients can find out if they qualify by visiting their gastroenterologist and consulting a financial assessment agency.
Hepatitis B has a particularly high presence in the Philippines and affects over 7.7 million Filipinos (about 1 out of every 10 people). It is also the most common serious liver infection worldwide and is one of the most challenging infectious diseases to manage. It places people at high risk of death from cirrhosis of the liver and liver cancer. The hepatitis B vaccine is 95% effective in preventing the hepatitis B Virus infection and its chronic consequences. The high burden of hepatitis B in the Philippines can be partially attributed to the patients’ inability to afford expensive treatments.

Pneumonia:

In July 2011, the Filipino Food and Drugs Administration approved the use of the vaccine Prevnar 13 (Pneumococcal conjugate vaccine) in adults aged 50 years or older. This vaccine is produced by Pfizer and is the first and only vaccine in the Philippines that aims to prevent pneumonia. Pneumonia is the leading vaccine-preventable cause of death in the country. Studies show that pneumonia is the leading cause of illness and the fourth leading cause of death among Filipinos over the age of 50.

Over the past year, Pfizer’s Filipino subsidiary has strengthened its campaign against pneumococcal diseases by working with local government units and organizations for an anti-pneumonia vaccination drive. Prevnar 13 is the Pfizer’s best-selling pharmaceutical product for pneumonia. The vaccine is currently in use in over 100 countries.

Dengue:

The dengue fever vaccine, developed by France-based pharmaceutical company Sanofi Pasteur, is currently undergoing advanced “Phase III” clinical trials in the Philippines. This is the final stage of testing before the vaccine officially becomes available to the public. The testing will take place in the cities of San Pablo and Cebu in Laguna Province and Cebu Province respectively. Based on initial test results from about 2,000 children in Laguna (aged 2-14 years) since July 2011, the vaccine has proved both safe and effective. While the testing is scheduled to last four years, it may be expedited if no dangerous side effects are found. Until the vaccine becomes available, authorizes are limited to public awareness campaigns to control mosquito populations.
Dengue fever, a mosquito-borne disease, infected almost 124,000 Filipinos in 2010 alone. Dengue hemorrhagic fever, a complication of dengue fever, was first reported and identified in the 1950s in the Philippines. The number of dengue cases in the Philippines continues to rise every year. There is currently no vaccine or treatment for dengue in the market. Researchers worldwide have been working on a dengue vaccine for the past 60 years. If final testing in Philippines is successful, the world’s first dengue vaccine will be released no later than 2014.