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On August 10, the Senate Health Committee will debate the bill “amending certain acts to ensure the functioning of health protection in connection with the COVID-19 epidemic and after it ceases”. The Polish Association of Pharmaceutical Industry Employers (PZPPF) warns that the changes proposed in the pharmaceutical law may result in drug shortages on the market, informs Medexpress.
- Until now, if the manufacturer was not able to deliver drugs to the market, he could ensure the availability of the product by importing it under the so-called intervention import
- After the changes, the only entity authorized to submit an application for consent for intervention in electronic form is to be a pharmaceutical wholesaler
- The introduction of these changes may result in drug shortages on the market and destabilization of public procurement
- Vice-president of PZPP: we call for enabling both drug manufacturers and pharmaceutical wholesalers to apply electronically for the possibility of intervention import
According to “Medexpress”, it is about changes in the pharmaceutical law that interfere with the organization of pharmaceutical supplies with the expected second wave of COVID-19.
Until now, when the manufacturer was not able to deliver drugs to the market, he could ensure the availability of the product by importing it under the so-called intervention import. Similarly to pharmaceutical wholesalers, he then applied for a written consent to the minister of health. Interventional import was based on the temporary consent of the ministry to place a drug that was missing or could replace the missing product on the market.
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What are the changes in the pharmaceutical law?
In the proposed provisions, the only entity authorized to submit an application for consent for intervention in electronic form is to be a pharmaceutical wholesaler. – The introduction of such a dualism seems unreasonable and gives rise to interpretation doubts. Especially that work is underway on the electronicisation of the entire procedure, which meets the expectations of all market participants – says Grzegorz Rychwalski, vice president of PZPPF.
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The introduction of these changes may result in drug shortages on the market and destabilization of public procurement, which raises particular concerns from the perspective of the current and expected epidemic situation in Poland.
– It seems incomprehensible to prevent drug manufacturers from submitting applications for consent for intervention import in electronic form, and to allow only pharmaceutical wholesalers. In the event of a possible shortage of drugs or an increase in the demand for pharmaceutical products unavailable in Poland, we deprive ourselves of the opportunity for pharmaceutical companies to fill the gaps. – says Grzegorz Rychwalski.
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Moreover, denying drug manufacturers the right to independently apply for authorization for intervention imports means that these entities will be forced to use the mediation of pharmaceutical wholesalers. This will entail the necessity to provide them with commercial data. In such a situation, the drug manufacturer would be dependent on a pharmaceutical wholesaler, which it would have to pass on, inter alia, contractor data or prices to be able to secure the supply of necessary drugs.
Appeal of the vice-president of the Polish Association of Pharmaceutical Industry Employers
Currently, in a situation where a drug manufacturer is unable to secure the won tender with its own medicinal product, it covers the costs of purchasing drugs by hospitals from pharmaceutical wholesalers. At that time, wholesalers obtain drugs most often by means of emergency import. However, the prices they propose are much higher than those offered to hospitals by manufacturers under tender contracts. Today, such market practices are restricted by drug manufacturers who obtain their own consent for intervention imports. The proposed changes to the law will prevent them from doing so.
– Bearing in mind the above, we call for enabling both drug manufacturers and pharmaceutical wholesalers to apply electronically for the possibility of intervention import – adds G. Rychwalski
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Source: PZPPF