Pharmaceutical Industry to Get First Nat’l Strategy, Action Plan

A first of its kind 10-year national strategy and a five-year plan of action for pharmaceutical manufacturing development are being developed by the World Health Organization (WHO) following a request by the government to develop the pharmaceutical industry and improve access to medicine.

The first draft of the strategic plan was discussed on June 2, 2015 in the presence of Kebede Worku (PhD), state minister for Health (MoH) and Mebrahtu Meles (PhD), state minister for Industry (MoI).

The draft national strategy was developed near the end of the first Growth & Transformation Plan (GTP I), which had failed to accomplish its targets for the pharmaceutical industry.

It aspires to increase the current market share of local pharmaceuticals manufacturers to 80pc by 2025 and the export earnings of the sector from the current two million dollars to 80 million dollars after 10 years.

In the first GTP, the government’s target for the pharmaceutical industry was to achieve full utilisation of the local pharmaceutical and medical supplies manufacturers; raise their local market share to 50pc and increase the export earnings of the sector to 20 million dollars.

The actual share of the local markets, however, with participation by all 22 local companies stood at 20pc and the export earnings of the sector was only two million dollars, far below the target in GTP one.

Incentives provided by the government for the local pharmaceutical sector during the first GTP, included tax free loans of up to 70pc for new companies and 60pc for well-established companies, 100pc Customs duty exemption on the import of capital goods such as construction materials and 15pc exemption of spare parts, two-year income tax exemption for companies that export 50pc of their products and others. But these incentives have failed to achieve the GTP I targets.

Financial and human capital problems in combination with the absence of defined policy were the problems in the first GTP and this strategy was necessitated because the government became convinced that access to medicine through local industrial development is an important substitute forimported medicine, which is 80 pc, Mebrahtu said.

TsigeGebremaryam (Prof.) WHO consultant and general manager of Regional Bio Equivalence Centre told Fortune that the government’s incentive revived the pharmaceutical sector but there were multi-faceted and complex problems of management, human capital and planning that rendered the companies’ incapable of producing at full capacity and therefore hindered the achievement of the GTP I targets.

The plan for improving access to medicine through locally produced quality products is to be implemented by ensuring that the companies comply with good manufacturing practice (GMP) andinternational manufacturing standards of WHO.

Ensuring that 20 companies will have international GMP by 2025 is the target of the draft strategy. Presently there are no companies with such qualifications, though the Ethiopian Food,Medicine & Health Care Administration & Control Agency (FMHACA) had adopted a GMP road map for implementation from 2013 to 2018.

The draft strategy has seven action plans, which include improving access to medicines through locally produced quality assured medicines, providing new incentives for local pharmaceutical companies to create import substitution, developing a pharmaceutical cluster, and production of active pharmaceutical ingredients (API). Among the additional incentives proposed by the new strategy, is the pooled procurement of raw materials.

Only one target in the GTP did not have a strategic plan and there was no clear cut time frame for the targets, monitoring and meeting objectives, Tsige said. The development of the strategic plan in combination with the action plans will give ownership to the targets both for the regulation and production and put a time frame in which the activities are to be accomplished, he added.


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