Health Secretary Pascoe Kase, while commending the Public Accounts Committee inquiry into the procurement and distribution of medical supplies, says procurement and distribution processes involved many stakeholders.
“It is not the Health Department alone.
“Government laws must be followed to buy and distribute medicines and PNG has its own procurement legislation in which all procurement for goods and services must comply with,” he said.
Mr Kase said this when clarifying that the decision on awarding the contract to Borneo Pacific Pharmaceuticals was made by the National Executive Council (NEC) on the recommendation of the Central Supply Tenders Board (CSTB) now renamed as the National Procurement Commission) for approval of contract up to the value of K10 million and not the Department of Health.
In a statement, he said the Department of Health therefore, must comply with the Public Finance Management Act and the National Procurement Act to procure medicines.
“Under these laws, the health secretary does not approve all contracts under review.
“The Health Department through the two established Technical Evaluations Committees does the initial technical assessment, then make recommendations to Central Supplies Tenders Board (CSTB – now renamed as the National Procurement Commission) for approval of contract up to the value of K10 million.
“Where the value is over K10 million, CSTB makes recommendations to the NEC for approval, legal clearance on all contracts is given by the State Solicitors, the Head of State then signs contracts based on advice from the CSTB and NEC,” he said.
He said it is not correct that Health Department took decision to award contract for drug supply to Borneo Pacific Pharmaceutical Limited (BPPL).
He said for the 100 per cent medical kits tender in 2014, the technical evaluation committees recommended a joint venture between Mission pharma and City Pharmacy Limited to the CSTB on August 27 2014 with BPPL second.
“It is not true that the Health Department removed ISO on Quality of Drugs, because the ISO 9001 for warehousing requirement was removed in the tender document based on a decision in a pre-bid meeting with suppliers, not outside of it as some commentators have noted.
“The pre-bid meeting of suppliers noted that the inclusion of the ISO 9001 on warehousing requirement would have excluded local suppliers from the bidding process.
“It is important to note that the ISO 9001 warehousing requirement was not a requirement in previous PNG Government tenders.
“It was included in this tender by an advisor without consultation or discussions with relevant stakeholders in PNG,” he said.
ISO requirements and Good Management Practices (GMP) including ISO 13485 for medical devices on the other hand, have always been our requirements, including the 2014 tender.
It is always our requirement for manufacturers to ensure the production of quality of medicines.
This meant that whoever won the tender in 2014 had to ensure that the medical supplies procured have a Certificate of Pharmaceutical Product (COPP).
This ensures that the drugs are registered and satisfied all the quality and safety requirements as certified by the National Regulatory Authority of the country of origin.
The International Dispensary Association (IDA) did not win the 100% medical kits tender in 2014 because it was ineligible as it was not registered in PNG.
Companies intending to do business in PNG must be registered in PNG under the Companies Act and the Medicines and Cosmetics Act.
It is not true that the Health Department makes no efforts to protect the people from substandard or counterfeit drugs
The Department of Health has a very strict policy of not circulating low quality or expired medical supplies.
Where there are expired medical supplies in health facilities, this could be due to a change in treatment guidelines or stock being slow moving. In these instances, stock management is the responsibility of each facility.
The Department of Health requires a minimum of 75% shelf life, which translate to around 2 years for most medicines. If the Health Department receives anything less than this then these are sent back to the supplier to be replaced.
Reports of low-quality drugs are investigated by pharmacy inspectors and samples are sent for testing at the Therapeutic Goods Administration in Australia under the Pacific Medicine Testing Program, or the World Health Organization accredited National Institute of Drug Quality Control lab in Vietnam. If the drug is found to be low-quality then the company is liable for the full cost of replacement. The distributor is held responsible.
PNG is the only country of the small pacific island countries to have a drugs testing laboratory
PNG now has a medicines quality control laboratory at Gordons to test medicines.
This Laboratory was support by the PNG government with technical support from the World Health Organization and the Center for Disease Control in Atlanta, United States of America.
Currently it is undertaking a survey and testing on commonly used medicines already in circulation in country.
I should note that the 100 per cent medical kits were tested in 2014 with 46 samples sent to the National Institute of Drug Quality Control lab in Vietnam.
Out of these only one sample failed while the rest passed. NDOH informed the supplier, who replaced that item in the kits.
Testing drugs is routine work, and are done all the time by the Department of Health using laboratories that are accredited by the World Health Organization.
What can also occur outside of normal procurement processes is that some health facilities negotiate directly with sister organizations to have medical supplies donated.
There is a normal donation process that should be followed that does not always occur, where donors inform the Government of PNG on available supplies and the government confirms its interest.