Bulgarian Generic Pharmaceutical Association

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BGPharmA position on the need to introduce a package of major measures to promote use of generic medicines

The Bulgarian Generic Pharmaceutical Association offers a package of major measures to promote the usage of generic medicines to support optimal use of public resources in healthcare:

1. Introduction of legal mechanism for obtaining reimbursement status and prices for generic drugs, together with receipt of the authorization and the marketing of products. This will allow immediate access of patients to more cost-effective generic products will be stimulated price competition in the market, which will lead to savings in the budget.

2. Exemption from regulation of prices of medicines which are not paid from public funds. This will shorten the time for medicines to patients and will stimulate competition in the market.

3. Remove overregulation in pricing and reimbursement of generic medicines.

4. Making changes in legislation to boost the administration and granting of generic medicines, especially for those paid from the budget and public funds.

5. Providing the latest information from the state to doctors, pharmacists and patients for the socio-economic benefits of generic medicines.

BGPHARMA welcomes the conclusions of the final report of the European Commission's study of competition in the pharmaceutical sector, presented in Brussels on July 8, 2009 following recommendations of the EC Member States:

- To significantly accelerate the procedures for approval of generic drugs, such as the Commission considers that generic products should automatically / immediately to obtain the status on fixing the price and reimbursement, when the original drug is already benefiting from this status, which will allow a faster release of product in some cases;

- To take measures, if found within their territory are carried out misleading information campaigns, question the quality of generic medicines;

- To ensure that third parties provide information and that in all cases, the information does not lead to delay approval of generic drugs;

- To encourage tests that examine the extent of added therapeutic value of new medicines.

The introduction of the above measures will lead to significant results for the Bulgarian society, such as:

1. More savings for a shorter time for the state and society, reducing the budgetary costs of drug therapy. Savings can be redirected to pay for more expensive treatments patients.

2. Increasing market competition between original and generic manufacturers, managing the growth of prices, more incentives for innovation by the producers of original drugs, more incentives for the entry of new generic products.

3. More affordable medicines to a greater number of patients and fulfill the purpose of public health.

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