Blocking competition in the drug market means higher prices and lack of availability

Domestic drug manufacturers support changes to the Reimbursement Act to improve Polish patients' access to therapies. - We want the reimbursement system, as a result of the changes, to be more efficient and provide patients with uninterrupted access to medicines, assures Krzysztof Kopeć, president of the National Drug Manufacturers.

Article 11.a to be removed

The draft amendment to the Reimbursement Law includes a provision preventing the submission of a reimbursement application for a drug that competes in price with a product whose patent protection is about to expire. Given that it takes up to six months to process an application, this will significantly delay the introduction of competition to the market. During this time, the NHF and patients will incur huge losses, as they will be paying a still high price for the drug, while it drops by at least 25%, and sometimes by more than half, once the competition enters.

The health ministry explains its proposal by concern over the lack of actual availability of cheaper drugs as a result of blocking their sale by the patent owner due to allegations of patent infringement. In such a situation, however, the health ministry could immediately shorten or suspend the reimbursement decision of the cheaper drug, or cancel it, revise the announcement and restore the previous price. - So neither the patient nor the National Health Service would be at a loss, as opposed to a situation in which - despite the registration of the cheaper drug - they still pay more while waiting for it to be covered by reimbursement. The provision thus works to the disadvantage of patients and the NFZ, because it prolongs the monopoly unnecessarily and keeps the price of the drug higher," says Krzysztof Kopeć.

Recipe extends monopoly for centuries

According to lawyers, such a provision would allow a drug's market monopoly to be maintained virtually indefinitely, because, according to it, the health ministry cannot extend reimbursement to a drug protected by any patent. Meanwhile, once a patent on an active ingredient expires, a manufacturer can apply for patent protection on various technological details, such as extended release time, and even such a patent, although not a significant barrier to bringing a competing product to market, will prevent reimbursement coverage. - One drug can be protected by as many as 3,000 patents," points out Dr. Żaneta Zemła-Pacud of the Institute of Legal Sciences of the Polish Academy of Sciences.
Prof. Pawel Podrecki of the Center for the Law of New Technologies of the Polish Academy of Sciences stresses that the proposal
contained in the amendment is a manifestation of the so-called patent linkage, i.e. the dependence of obtaining an administrative decision on its patent status. - The European Commission has defined patent linkage as unlawful and prohibited under European law, he points out.

Accelerate competition

- The idea of intellectual property protection was born out of the need to stimulate progress. It was intended to provide an incentive to find new solutions. However, overextending it does not accelerate innovation. Prof. Eric Maskin, a Nobel laureate in economics, stressed that progress is usually a large number of successive steps, with each successive step building on the previous ones. And if we patent such a step for too long, we will block the next one, which will slow down progress, Krzysztof Kopeć argues.

- A report by the European Commission's Pharmaceutical Sector Inquiry indicates that everything must be done to make a price-competitive drug available to patients on the first day after patent protection expires. This will make patients and the public payer pay less. For this to happen, the reimbursement process must start earlier, so that the drug can be included in the first reimbursement notice after the monopoly expires, recalls Grzegorz Rychwalski, vice president of National Drug Manufacturers.

He adds that an amendment to the EU's SPC Manufacturing Waiver came into effect last July, which allows competing drugs to be manufactured and stockpiled six months before the end of the protection guaranteeing market monopoly (SPC), in order to be ready to launch a product on the first possible reimbursement notice on the first day after its expiration.

- It should be emphasized that the Ministry of Health has no statutory or substantive authority to examine the patent situation of a drug. In the Polish legal system, only a specialized patent court has them. And if, after several years of patent litigation, the court finds that a competing drug had the right to enter the market and reimbursement, the Health Minister would be the one who illegally blocked competition, and this act would be the basis for the payment of compensation by the Treasury. Thus, as citizens, we would lose threefold: one - because as patients we would pay unnecessarily more expensive for the drug at the pharmacy, two - because the National Health Service would spend more of our premiums on therapy losing funds that it could have allocated to expanding access to treatment or new drugs, three - because the manufacturer of the blocked drug could seek compensation from our taxes for the actions of the Health Ministry," points out Grzegorz Rychwalski. He adds that domestic manufacturers have prepared a proposal for comprehensive changes that protect patients and allow the NHF to direct compensation claims to companies for unjustifiably blocking competition in the market.