Health Ministry orders FDA to halt dealings with codeine cough syrups

The Ministry of Health has ordered the Food and Drugs Authority (FDA) to suspend the registration, importation and manufacturing of cough syrups containing codeine with immediate effect.

The ministry has also directed the FDA and the Pharmacy Council to enforce the requirements for the distribution of tramadol, products containing the drug and all doses of codeine registered by the FDA strictly as prescription-only drugs and controlled medicines.

Launching the reviewed edition of the National Medicines Policy in Accra yesterday (Friday, June 22, 2018), the Minister of Health, Mr Kwaku Agyemang-Manu, said the measures were part of efforts to effectively deal with abuse of tramadol and the abuse of cough syrups that contain codeine, particularly, among the youth.

“My full statement on these directives will come shortly as the ministry is taking steps to work with the office of the Attorney-General for appropriate executive instruments to be issued on these actions,” he said.

Mr Agyemang-Manu indicated that the directives formed part of regulatory measures under the revised National Medicines Policy, based on the advice of the Technical Advisory Committee of the FDA to protect public health and quality healthcare delivery.

Policy review

This is the third time the National Medicines Policy has been reviewed. The first policy document was adopted in 1999 and was reviewed in 2004 and 2017.

The review is to ensure that the policy better responds to the pharmaceutical needs of the country by addressing gaps in the previous editions, such as implementation frameworks, alignment to the Sustainable Development Goals (SDGs), among other gaps.

The overall goal of the policy is to ensure universal, equitable and sustainable access to priority, efficacious and safe medicines, as well as health technologies of acceptable quality for all Ghanaians and all resident non-Ghanaians.

The policy has been revised to provide direction and guidance to all stakeholders in the pharmaceutical sector in Ghana.

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The revision has been informed by the need to strengthen pharmaceutical systems as a key component of health systems to meet the ever-changing health needs of the population.

The policy review is driven by the government's medium-term development strategy as outlined by the National Development Planning Commission and the Health Sector Medium-Term Strategy by the World Health Organisation’s (WHO's) ) guidelines for drug policy development.

The policy has five main clusters. They are selection of medicines, governance, global trade, research and development; use of medicines; as well as quality assurance and strategic purchasing.

Agreement

Mr Agyemang-Manu said last month, the ministry signed a memorandum of understanding (MoU) with suppliers under which 54 products were to be procured based on a pre-determined pooled procurement prices with effect from June 1, 2018.

He said the prices of pharmaceuticals remained a big challenge for the government and, therefore, stakeholders were expecting that the impact of the agreement on the prices of pharmaceuticals would be felt very soon.

Affordability

To ensure that pharmaceutical products were affordable, the health minister said the government promised in its manifesto in the run-up to the 2016 general election, to remove value added tax (VAT) on all medicines listed as essential in 2017.

“This action, the government believes, should lead to the reduction of prices since VAT forms 40 per cent of total taxes on pharmaceuticals. The VAT exemptions came into force on November 3, 2017,” he added.

Mr Agyemang-Manu announced that effective July 1, 2018, prices of all NHIS medicines would be reduced by an average of 30 per cent.

Second Lady’s remarks

In her remarks to officially inaugurate the third edition of the policy, the Second Lady, Mrs Samira Bawumia, said the policy was an expression of the government’s commitment towards ensuring universal health coverage.

Mrs Bawumia said issues affecting health were widespread and addressing them required an approach that would ensure that every individual and community, irrespective of their circumstances, received the health services they needed

WHO

The World Health Organisation’s Country Representative, Dr Owen Kaluwa, commended the broad consultative process used in the review of the policy.

He said the WHO applauded such a policy because of its ability to improve access to self-efficacious medicines.

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