Monday, 6 january 2020 | Redacción CEU
At the end of last year, the media picked up on one of the most urgent problems in the pharmaceutical industry: drug shortages. Today, on The CEU IAM Blog, we try to shed light on this phenomenon that this sector has been suffering for the past few years. What exactly are drug shortages? Are “shortages” and “supply problems” similar concepts? Is this just a Spanish problem or does this phenomenon also affect other countries? What solutions do the pharma industry and the public administration put forward?
Last December, the Spanish Agency for Medicines and Health Products (AEMPS by its initials in Spanish), which is a body dependent on the Spanish Ministry of Health, published a list of more than 500 drugs that had supply problems at that time. This was a significantly high figure compared to the data which was recorded in this same period last year. Indeed, the newspaper El Periódico pointed out that this data accounted for an increase of 40% over the previous year. Therefore, this is an upward phenomenon; a problem that has characterized this pharmaceutical industry in recent years and that has been commonly called "drug shortages".
First of all, it is important to define what "shortage" and "lack of supply" really mean, since both concepts are often used interchangeably, despite the fact that they describe different realities. Shortages are related to the lack of authorization, that is, drugs are removed from the market. Thus, although most of the time people talk about a problem of drug shortages, they are actually referring to a problem of a lack of supply. AEMPS itself describes this last scenario as a situation in which the available units of medicines in pharmacies are lower than the national or local consumption needs. In other words, the drugs that are offered are not proportional to the demand. This body indicates that the main causes of this situation are related to the manufacturing and distribution of medicines.
AEMPS is not the only entity that regularly publishes reports about these problems. The Collegiate Pharmaceutical Organization also offers a list of medicines with non-supply through CISMED. This body publishes the data obtained thanks to the collaboration of thousands of Spanish pharmacies every week. This is a useful tool for the early detection of possible supply problems, because it distinguishes drugs that have generated alerts for at least three days or more in one or several regions, drugs that have had a lower incidence (so they are under observation) and drugs that have no supply problems.
The lack of drug supply and drug shortages are not only Spanish problems, they also affect its nearby countries, especially the European ones. This is a complex problem in which multiple factors come into play. In some cases, they are problems related to production (for example, due to the lack of raw materials), to safety or quality goals (the standards in the EU are strict), to other issues like labeling. The lack of supply may also be related to a miscalculation when estimating the demand for a drug or to the implementation of some type of commercial strategies.
One of the most controversial aspects related to this problem is that of reference prices, which are the maximum prices that the Health System pays for medicines. These serve to control public spending on healthcare, but they can also have the effect of laboratories not be willing to produce them. Another factor that we should take into account is that the production of active ingredients is usually concentrated in few countries. Most of them are located in Asia. This means that should there be a problem in these regions, the effects may be global.
Generally, the different organizations agree that there is not a public health problem related to this supply problem, since they claim that there are alternatives for the drugs which are affected in the vast majority of cases. Nonetheless, this is a growing phenomenon that requires analysis and study, the collaboration of the different agents who are involved and the design of strategies that can help to solve the problem.
One of the last proposals of the pharma industry to try to solve this problem is the national production of essential medicines that are or may be affected by shortages or supply problems. This is a measure that, according to Farmaindustria, could be an opportunity to create employment and a productive framework in Spain, and to promote the exports in this country.
Last May, the 2019-2022 Supply Guarantee Plan carried out by the AEMPS was agreed on in the plenary session of the Interterritorial Council of the National Health System with the aim of offering a solution to these supply issues. This plan contains three general goals: the prevention, management and information of supply problems. One of the proposed actions of this plan with the greatest impact is the modification of the penalty regime to include serious sanctions that serve as a deterrent in order to avoid supply problems.
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