A new pricing system and that nurses can prescribe: this will be the new drug law

BarcelonaIn the last decade there have been supply problems in pharmacies and difficulties in accessing certain therapies, which the Spanish government attributes to scientific, industrial, and social changes that have fully impacted the pharmaceutical industry. For this reason, this Tuesday the executive approved in the Council of Ministers the draft law on medicines and health products, a comprehensive reform that seeks to avoid shortages, facilitate access to innovative medicines, and adapt prescription and dispensing to the new needs of the national health system. It also incorporates a new pricing system with which it aims to "promote competition and the penetration of generics".

One of the novelties of the regulation, which will now have to be debated in the Congress of Deputies for final approval, is the inclusion of the concept of "strategic medicine", which refers to a drug indispensable for the health system that has a "vulnerable" supply chain. The objective is to ensure that this drug remains on the market, for which the Spanish Agency for Medicines and Health Products (AEMPS) will be able to adopt special economic and regulatory measures to prevent shortages. In addition, in the face of public health emergencies, laboratories, distributors, and pharmacies will have to report on the stock of these medicines.

The Spanish government also reorganizes how drug prices are set. The objective is to promote competition between brands and ensure that public healthcare saves money. Two different methods will be combined, which will never be applied simultaneously to the same medicine. On the one hand, the traditional reference pricing system is maintained as a general rule. This approach groups medicines that have the same active ingredient and are taken in the same way to establish a maximum ceiling of money that the State is willing to pay.

On the other hand, the figure of dynamic pricing is created, specially designed for medicines that no longer have a patent, such as generics. In this case, the price of the drug will be automatically reduced as its market presence increases. For example, when a generic reaches 50% or 70% of the total sales of its group, the law will require a reduction in its industrial price, so that prices will be "more competitive".

Finally, the rule introduces a range of funded prices to allow more expensive and cheaper options for the same treatment to coexist. The ministry sets a maximum limit that covers the cost of the most efficient options, and all medicines below this threshold will be funded. If the patient chooses a medicine within this limit or the cheapest one, they will only pay their usual co-payment percentage. However, if they prefer a specific brand that exceeds this limit, they will have to pay the price difference compared to the funded limit, in addition to the co-payment. In this way, the public system does not assume "additional costs" for brand preferences, but the patient retains the freedom to choose.

Prescription

The new law also includes one of the historic demands of the healthcare sector: that nurses and physiotherapists can prescribe medicines and healthcare products. Thus, they are integrated into the prescribing team along with doctors, dentists, and podiatrists, each within their own competencies. Within a year, the regulatory framework will be updated to harmonize the prescribing practice of all these professionals, which means that the necessary protocols for coordination between doctors, nurses, and physiotherapists will have to be developed.

Another of the new features is the improved access to medication in exceptional health situations, such as in cases of dependency, disability, or vulnerability where the patient has difficulty traveling. In these cases, the patient will not have to physically go to the hospital pharmacy service or the pharmacy, "always under the responsibility of the dispensing center and with guarantees of traceability, conservation, transport, and pharmaceutical care." The Spanish government clarifies that this is not a remote sale of medicines, but "a way of bringing dispensing closer to the patient" in very specific cases.

The law will also allow certain innovative medicines to be incorporated early into public provision when they cover an unmet medical need or when treatment cannot be delayed, even if there is uncertainty about their effectiveness or their definitive economic impact. During a provisional period, the Ministry of Health will evaluate the response of patients taking this medicine and, if a benefit is confirmed, the "funding may be consolidated under the agreed conditions." On the other hand, if the results are not satisfactory, or if the final price ends up being lower than the provisional one, the laboratory will have to compensate or return the corresponding amounts.

Parliamentary phase

Now the law will have to be debated in the Congress of Deputies to decide whether to approve it or not and how. Jordi Casas, president of the College of Pharmacists of Barcelona and of the Council of Colleges of Pharmacists of Catalonia, believes that it is an opportunity to adapt and modify some aspects, even though the proposal includes historical claims from the sector. Casas warns that the planned measures "may limit citizens' access" to certain medications "without sufficient clinical justification", as they would be forced to travel to hospitals to obtain specific drugs.

He also believes that some provisions that "may generate uncertainty and possible inequalities in access to medications financed" by the National Health System and the new pricing model "could lead to unforeseen co-payments, difficulties in adherence to treatments and situations of inequality between patients".