Furore as drug distribution guidelines take off July 1

In as much as industrial pharmacists long for a sector devoid of counterfeiting loopholes and illicit trading activities, it appears they are far from ready for the desired change.

The new National Drug Distribution Guidelines (NDDG) initiated by the Federal Government in 2012 to reform and regulate drug distribution in the country was commended by the stakeholders to sanitise the system. But on second thought, practitioners foresaw a disaster for investors should the guidelines be implemented wholesale.

Amidst arguments for and against the policy, the implementation date has been shifted for the umpteenth time, and it appears the July 1, 2015 new date may just suffer the same fate.

While there was no doubt in their minds that the guidelines seek to establish a well-ordered drug distribution system for Nigeria, industrial pharmacists see no wisdom in implementing the guidelines without plans to first regulate drug entrepreneurs (wholesalers) and the chaotic distribution system, address inadequate Mega Distribution facilities and protect interest of local manufacturers that are often at the mercy of their marketers and sales representatives.

Meeting at the bi-monthly meeting of the National Association of Industrial Pharmacists (NAIP) recently in Lagos, the manufacturers submitted that the guidelines had merely created a business model, without additional value or alternatives should it fail at implementation.

A member of the policy drafting committee, Dr. Lolu Ojo, informed the practitioners that the guidelines had erected pillars and clearly delineated channels of distribution with roles and responsibilities.

According to the policy, the manufacturers and the importers are at the apex of the ladder and their role is to make the drugs available and sell only to Mega Drug Distribution Centres (MDDC), State Drug Distribution Centres (SDDC) and National Health Programmes.

The next layer is occupied by the MDDC and the SDDC. While the MDDC is private sector-driven, the SDDC is for the public sector at the state level. The SDDC will cater for all public health facilities in the state and is also allowed to sell to National Health Programmes (where indicated) and wholesalers. The MDDC is allowed to sell to wholesalers only.

The wholesalers, being one of the main concerns of the dissatisfied stakeholders, occupy a pivotal role in the value chain. Purchases can be from MDDC or SDDC but not from the manufacturers or importers.

The wholesaler is allowed to sell to community pharmacies, public/primary healthcare facilities and private health institutions. With this function clearly spelt out, there is really no need for a wholesaler to engage in retailing as it is now.

At the bottom of the distribution ladder, are the community pharmacists and public/private health institutions who sell directly to the consumers. The community pharmacy is also allowed to sell to private health institutions.

There are other provisions which affect pharmacists directly. All drug retailing institutions, including private hospitals, local government clinics (a pharmacist is allowed to supervise four clinics) must be registered by the Pharmacists Council of Nigeria (PCN). With this, more employment opportunities will open for pharmacists. A lot of practitioners will disagree.

President NAIP, Gbenga Falabi, observed that counterfeiting was one of the main problems before the sector today, and the talk about solution would be incomplete without the supply chain.

Falabi said while several companies and regulatory agencies were choosing different strategies to safeguard products and foil faking, it was quite disturbing that counterfeiters were having a filled day.

A particular example is the Mobile Authentication Services (MAS) initiated by the National Agency for Food, Drugs Administration and Control (NAFDAC). While N90m was spent to drive the campaign, less than 24 per cent of consumers still text the codes to check the validity of their antimalarial drugs, Falabi said.

Apparently undaunted by the albatross of counterfeiting, he said practitioners must begin to consider other options, one of which is the much awaited NNDG.

Chief Executive Officer (CEO), Neimeth Pharmaceutical PLC, Emmanuel Ekunno, added that the NNDG policy was well intended to grow the manufacturing sector, narrow faking, clean up the value chain and promote professional prosperity.

On the flip side of the coin, however, is the disruption in the status quo, the need for adequate preparedness by practitioners and the enormous risk of poor execution at the point of implementation.

“July 1 is about a month away and should the new minister of health choose to implement the policy, we are ready. The NDDG is well timed,” Ekunno said with much optimism.

Chairman of Fidson Healthcare, Dr. Fidelis Ayebae, however, disagree. Ayebae, with 20-years experience in the sector and chairing a company of N200b worth of investment, was quick to remind his colleagues that distribution remains the sole of the pharmaceutical industry, without which either drug manufacturers or its importers are incomplete.

“This policy is entirely about distribution and if we get it wrong at the distribution level, we are all doomed,” Ayebae said.

Like Ojo and Ekunno, he explained that the policy was “healthy”, but everything is wrong operating it in a “chaotic drug distribution system, still perpetrated by charlatans (the drug marketers/entrepreneurs/wholesalers).”

He observed that the policy had only introduced the Mega Drug Distribution Centres (MDDCs) into the value chain, without plans to address issues of marketers, upon whom 60 to 70 per cent of the distribution chain rests.

“The first thing to do, in my opinion, is to allow the NDDG to run evolutionarily and not revolutionally. Because by introducing the policy and insisting on a commencement date for everyone to fall in line, it is going to be a disaster. They (Mega Distributors) cannot meet your target nor meet mine.