A proposed new Act on Reimbursement for Medicinal Products, Foods and Medical Products calls for the Polish national health service to reimburse the costs of “special-purpose foods” when they offer documented health benefits.
On 19 October 2010 a bill was submitted to the Polish parliament to introduce a new law entitled the Act on Reimbursement for Medicinal Products, Foods and Medical Products. The bill provides for expansion of the group of persons entitled to apply to the Polish Ministry of Health to subsidise the purchase of products by patients. The act would allow reimbursement from the state budget for certain special-purpose foods for patients, in addition to medicines and medical products already covered. The bill, designed to encourage preventive medicine, also represents an opportunity for the foods industry.
Special-purpose foods are a strictly defined category of food products whose ingredients or preparation is clearly differentiated from commonly used foods in order to meet specific nutritional needs. Such foods are subject to special regulations concerning labelling, ingredients and introduction onto the market, and require notification of the Chief Sanitary Inspectorate.
The bill provides for the ability to obtain reimbursement for dietetic products and products for healthy infants and small children up to age 3. This means that not all of the products subject to notification of the Chief Sanitary Inspectorate will be eligible for reimbursement. It is clear, for example, that reimbursement would not be available for products designed to support intensive physical training.
Under current law, pharmaceutical companies may seek reimbursement for medical products designed to meet special nutritional needs. Such products are now classified as medicines and covered by the Pharmaceutical Law. Introduction of the ability to seek reimbursement for products classified as foods is an opportunity for the foods industry, but to make good use of it, companies from the industry will be required to develop objective documentation of the health benefits for patients using their products. This will be a challenge, because the formal requirements are rigorous, competition is great, and the budget for reimbursement is limited. If an application is rejected by the Minister of Health, however, there is an appeal procedure available to the producer.