26 IV this year. The European Commission adopted a package of amendments to European pharmaceutical law. The National Drug Manufacturers have submitted their comments to the government side, which will prepare Poland's position on the issue.
National Drug Manufacturers on changes to European pharmaceutical law
Published May 16, 2023 11:34
Unfortunately, the draft does not provide for the introduction of a legal and financial mechanism for the restoration of Europe's drug safety, i.e. the restoration of API and drug production. - A reference calling on the European Commission to urgently develop a legislative act implementing the provisions of the Pharmaceutical Strategy and EU strategic documents should be introduced into the draft directive and regulation, Krzysztof Kopeć, president of the National Drug Manufacturers, urges. Instead, the document introduces incentives for the production of drugs that address urgent health needs in the form of extending their monopoly, which could ultimately hinder access to these therapies. The PZPPF believes that the protection period for monopoly drugs, which is already the longest in the world, should not be extended. - Although the pharmaceutical package talks about shortening drug exclusivity periods, the de facto regulations open up a whole range of possibilities for its extension," points out Grzegorz Rychwalski, vice president of the PZPPF.
The National Drug Manufacturers, however, view positively the proposal for incentives in the form of 4-year data exclusivity for generic drugs in the new indication. - After all, it is these drugs that are most often in short supply in pharmacies, so it makes sense to encourage increased production. Besides, this promotes de facto innovation at affordable prices. - adds the president of PZPPF.
In the EU, drugs have the world's longest monopoly
The market monopoly in the EU provides drugs with more than just a patent. The framework of legal protection beyond it is formed by an additional certificate of protection - SPC, data exclusivity and market exclusivity. Lasting 20 years, patent protection is the right to the exclusive use of an invention covering, among other things, the production, offering, sale, import, storage of a drug. SPC provides a 5-year monopoly providing compensation for the many years of research already conducted after obtaining a patent to market the drug. Data exclusivity is a product protection instrument that prohibits third parties from referring to the drug's registration dossier. After 8 years of data protection, we still have a two-year period of market exclusivity. During it, a registration application for a generic drug referring to the results of the protected drug can be filed, but the generic cannot be marketed. It should be noted that the protection in force within the EU - which includes, in addition to the patent, 8 years of data exclusivity, followed by a two-year period of market exclusivity that can be extended for another year (the so-called 8+2+1) - is the longest in the world.
By comparison, the system used in the U.S. provides for a standard 5-year data exclusivity period.
A shortening that de facto lengthens the
The EU's proposed changes, while shortening the data protection period to 6 years, introduce a number of exceptions to the rule. Companies can benefit from additional protection periods by increasing the total period of protection to a maximum of 12 years, or even 13 years, compared to the current 11 years. - In total, therefore, the proposed changes extend the total protection period by up to 2 or 3 years relative to the current law , says Grzegorz Rychwalski.
Additional periods of protection can be obtained if companies introduce the drug in all EU countries (+2 years), if the drug addresses an unmet medical need (+6 months), or if comparative clinical trials are conducted (+6 months). Another year of protection is granted if the drug can also be used to treat other diseases. - We believe that the world's longest exclusivity period already limits the availability of therapies in the EU. Therefore, the incentives advocated by the draft directive for registering drugs in all EU countries, registering new indications and conducting comparative studies should be retained, but with a reduction in the duration of the basic data exclusivity period to 4 years. The incentives should be designed so that the aggregate duration of data and market protection does not exceed 11 years, as at present ," points out Grzegorz Rychwalski.
He adds that if the drugmaker had not taken any measures to extend protection, it would have obtained 4 years of data exclusivity and 2 years of market exclusivity, a period comparable to that currently in the US. If all incentive measures were implemented, the period of registration exclusivity would remain at the current level, the longest in the world.
Voucher for sale
The EC's planned changes also include the introduction of a transferable Exclusivity Voucher (TEV) for antimicrobials, primarily antibiotics, to encourage their production. The Voucher would extend data protection for one year, with the option to transfer it to another company, which would extend data protection for itself for any of its products. - Vouchers would be redeemable by the richest companies to extend the monopoly of their drugs. Therefore, we believe that if they were already to be introduced, they should be non-transferable and assigned to the antibiotic that formed the basis of the grant, recommends Krzysztof Kopeć.
Voluntary license is best
The European Commission unveiled a separate Patent Package on April 27, which, among other things, includes regulations for compulsory EU licensing for crisis management. This means that in the event of a pandemic or other crises, a patent-protected drug could be produced not only by the patent holder, but also by other companies. According to the PZPPF, a better solution is for the patent holder to voluntarily grant a license to another entity that is unable to produce sufficient quantities of the drug in a crisis situation. However, as the Covid-19 experience has shown, this is not always the case. It is worth emphasizing that "EU compulsory licensing" will only be possible in exceptional circumstances after the failure of voluntary licensing, for a specified period of time and with appropriate compensation to the patent holder.
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