Concerns Over New Medicines Law: "It Could Lead to Loss of Treatment Adherence"

There is a significant reform looming for our country's pharmaceutical system. The Council of Ministers has recently approved the Draft Law on Medicines and Health Products, which promises to change key aspects of how we will acquire drugs from now on.

The law aims to consolidate aspects that were already considered previously, such as the prescription being established by active ingredient. Practically, this means that doctors will prescribe Ibuprofen or Paracetamol, instead of one of the various brands under which laboratories market these active ingredients.

However, there will also be novel measures, such as a new reference pricing system for medicines which, according to the Ministry of Health itself, seeks to "promote competition among laboratories." Unlike the current system, which imposes a single price on all equivalent medicines, the new approach will require companies to submit price offers every six months. Based on these, the Health Ministry will select the products offering the most competitive price.

This model will introduce a price range within which medicines will be fully funded by the National Health System. On paper, it will give users greater freedom of choice, as they will have more variety of funded drugs available after a prescription. However, this seemingly beneficial freedom of choice raises concerns among experts, who fear a loss of adherence to pharmacological treatment as a result of this measure.

This is the view of the president of the Official College of Pharmacists of Alicante, Andrés García Mongars, who speaks of a kind of "invisible copayment" that many users could face due to the new system.

The price range of funded medicines will change every six months, based on the offers submitted by laboratories. This opens up the possibility for consumers to find that the specific drug they have been taking falls outside the price range covered by the Health Ministry, and if they wish to continue treatment with that specific presentation, they will have to pay the difference. Hence the reference to a "copayment" by the president of the COFA.

"For many patients, especially those on multiple medications, it is very important to maintain the same type of treatment. So if every six months they have to pay extra to ensure the blue, elongated pill does not change to a yellow, round one, even though both have the same active ingredient, there is a risk they will abandon the treatment, and therefore adherence will be lost." In other words, with so much change, the patient may stop being consistent in taking the medication, and thus the treatment loses its effect.

The president of the COFA has fewer doubts about other aspects of the new regulation, such as the one that allows pharmacists, in the absence of a medication, to dispense an equivalent one without needing a new prescription from the doctor.

A new category of first-prescription medicines is also created, which are those linked to a clear and recurrent diagnosis and can be dispensed on successive occasions directly from the pharmacy.

Another crucial aspect of the new law is the proposed measures to ensure the availability of strategic medicines. Mongars explains that this strategic nature is determined by the context, for example, marked by the shortage of certain products.

The law includes regulatory, economic, and various other measures to encourage the permanence of these strategic drugs in the market, "thus controlling production and avoiding dependence on other countries"; something that in a global market subject to volatility, can compromise supply.