Strategic medicines that meet two main requirements. In the first place, they are considered critical or essential for the health system, that is, they are very necessary to treat certain patients, since these medicines do not have therapeutic alternatives or these are not satisfactory. In addition, they are considered vulnerable to supply, because they are marketed by only one or two laboratories at most.
The confluence of both characteristics, criticality and supply vulnerability, makes it necessary to adopt regulatory, economic or other measures in order to guarantee its availability.
Spain was the first country in Europe, in May 2022, to establish a list of strategic medicines in order to ensure the supply and guarantee the access of Spanish patients to these drugs that are so relevant to the health of the population.
This is a dynamic list, which is being updated and which currently contains 541 drugs with 291 different active ingredients, which can be consulted on the website of the Spanish Agency for Medicines and Health Products (Aemps).
What kind of drugs are they?
There are drugs for a wide variety of pathologies. The most common are treatments for central nervous system (25%), followed by anti-infectives (22%) and oncological (13%).
They are generally veteran drugs. In fact, 43% were authorized before the year 2000. The vast majority do not have patent protection and some of them have very low prices that are constantly eroding as they are subject to the reference price system —a procedure by which each year the price of off-patent medicines. However, despite their low economic impact, these drugs are of paramount importance from a health point of view: many of them do not have an easy therapeutic alternative and their supply problems create significant problems for the National Health System (SNS).
Do they enjoy protection?
The SNS provides for regulatory protection, which includes streamlining administrative and regulatory procedures (such as preferential management of authorization evaluations), scientific and regulatory advice throughout the process, and support for internationalization.
It also provides for economic protection, although as of March 2023 these measures still have to be developed. Said protection should allow the price of some of these medicines to be revised upwards, a measure that would contribute to their maintenance on the market. Many have low sales volumes, which, added to low prices and few manufacturers, poses a challenge to their commercial viability..
Given that some presentations of these medicines are included in the reference price system and their price cannot be revised upwards, it seems necessary to promote a regulatory modification so that the price of these medicines is set by the Administration on a case-by-case basis and not by the automatism of this system.
However, some steps have already been taken. For example, the Profarma Plan — promoted by the Ministry of Industry — included strategic medicines in 2021 as a favorable scoring element for pharmaceutical companies that manufacture them in national territory.
What are the drugs that clearly need marketing authorization?
Closely related to the strategic ones, Aemps has also identified a series of medicines ‘with a clear need for marketing authorization’. In this case, these are drugs that are not authorized in our country (in some cases they were), but that are necessary for some patients and, therefore, are purchased abroad as imported drugs.
On some occasions they are imported individually, for a single patient, and on others, collectively. This last case occurs, above all, when there is a supply problem of other similar drugs available in Spain. Between one and the other, Spain managed more than 100,000 import applications between 2022 and 2023, according to recent data provided by Aemps.
For this reason, the Agency considers it necessary that these medicines be authorized and begin to be marketed in Spain, which would be considered strategic.
Why is it important to produce them in Spain?
The pandemic showed how drugs are a strategic security asset. Spain has 103 manufacturing plants for medicines for human use and is, in fact, one of the European countries with the greatest potential for pharmaceutical manufacturing. However, the characteristics of drugs considered strategic can lead to their disappearance from the market or to their majority production in countries such as China or India, where production costs are lower and implementation conditions are less demanding.
These drugs are considered among the minimum necessary for the proper functioning of the health system.
Spain, however, has the capacity to increase production and both from the Government and from the companies -through the Strategic Plan for the Pharmaceutical Industry- there is a commitment to promote reindustrialization in this area. In the context of the aforementioned Plan, which is already being worked on, the pharmaceutical industry has set investment targets for a value of 2,700 million euros to reinforce productive capacities in the next three years.
Having our own production of strategic medicines in Spain and Europe gives the country and the environment greater strategic autonomy. This means greater security in the face of challenges of various kinds. This includes healthcare, such as the pandemic and the increase in demand for drugs that unbalanced the markets, but also other crises such as energy, inflation or even the war in Ukraine, which have caused a mismatch in the production chains that has translated into increased costs or broken supply chains.
In fact, one of the pillars of the Strategic Plan for the Pharmaceutical Industry is precisely to achieve strong national and European industrial capacities and resilient drug supply chains.
The patients, the beneficiaries
Patients are the main beneficiaries of gaining production capacity for strategic medicines in Spain, as rapid and continuous access to the treatments they need would be guaranteed. These drugs are considered among the minimum necessary for the proper functioning of the health system, so guaranteeing their availability is to ensure the health of society as a whole.
It would also have a direct impact on the country’s economy, due to the consequences on employment, productivity and the economy, thanks to the investment by pharmaceutical companies in production plants already installed or in newly created plants.