Availability of medicines

  • Definitions
  • Overview of available and unavailable medicines
  • Temporarily unavailable medicines
    • Causes of temporary unavailability of medicines
    • Number of products unavailable
    • Solutions and actions
  • Interruption and discontinuation of commercialisation
    • Causes of interruption or discontinuation of commercialisation of medicines
    • Number of interruptions or discontinuations
    • Solutions and actions
  • Reporting a change in availability
  • Contact

 

 

Definitions

The FAMHP invests in an efficient and effective approach to the availability of medicines.

 

We make a distinction between the following situations.

  • Available medicine

A medicinal product that is available on the Belgian market and for which the marketing authorisation holder or parallel distributor has notified the FAMHP that it is being marketed in Belgium.

  • Temporary unavailability

A medicinal product that has been unavailable for no more than one year and for which the marketing authorisation holder or parallel distributor has notified the in advance FAMHP that it is being marketed in Belgium.

  • Interruption of commercialisation

A period of unavailability that is expected to last longer than one year, but where the intention is to re-market the medicine.

  • Discontinuation of commercialisation

A medicine whose commercialisation is permanently discontinued.

 

Overview of available and unavailable medicines

Since December 2019, periods of unavailability, interruptions and discontinuations of commercialisation of medicines for human and veterinary use are published on PharmaStatus.

 

The lists of medicines are updated on each business day based on reports from marketing authorisation holders or parallel distributors.

 

Temporarily unavailable medicines

Causes of temporary unavailability of medicines

A medicine may be unavailable for a variety of reasons.

 

  1. Actual unavailability

A genuine stock shortage can be caused by, for example:

  • unavailability of the active ingredient;
  • unavailability of an excipient;
  • delay in production;
  • delay in the release of the final product;
  • logistical problems (transport, customs, etc.);
  • increased demand;
  • FMD – serialisation;
  • import and export authorisation in application (psychotropics, narcotics);
  • recall;
  • force majeure (strike, disaster, etc.) ;
  • patent litigation;
  • other reasons.

This means the marketing authorisation holder or parallel distributor cannot supply the medicines.

 

  1. Distribution issues

Due to a local distribution issue, a medicinal product may only be unavailable from some pharmacies or veterinarians. In this case, the medicine is not genuinely unavailable.

 

Another distributional problem is the use of quotas. This practice is used by a number of pharmaceutical companies, whereby they interrupt deliveries to dispose their stock in a controlled manner. Based on the previous year's consumption, the company estimates the quantity of medicines that needs to be produced annually to meet the needs of the Belgian market and limits periodic supply to ensure that the number of scheduled batches is sufficient to supply the Belgian market throughout the year. If quotas are applied, the company still has batches available, but the pharmacist cannot order them through the wholesaler-distributor. In practice, such cases usually occur only at the end of the month and the medicine is available again at the start of the next month. For patients, however, the problem remains the same: they cannot obtain their medicines, or the pharmacist has to take extra steps to obtain it.

 

Number of products unavailable

Reports of temporarily unavailable packs of medicines for human use represent, on average, 3.5 percent (2021 data) of the total number of packs for human use placed on the market in Belgium. The increase in the number of packs reported as unavailable since 2019 does not necessarily indicate an increase in the unavailability situations themselves, but an increase in the reports of unavailability. This is partly because the FAMHP is raising awareness among marketing authorisation holders and parallel distributors of the importance of reporting unavailability, and partly because of the Law of 20 December 2019, which clarified and tightened the reporting requirement.

 

Since April 2021, pharmacists and wholesaler-distributors have been able to contact marketing authorisation holders and parallel distributors through PharmaStatus in the event they suspect a shortage or supply issue to occur. This system encourages companies to pass on their reports correctly.

 

Reports of unavailability are made for each presentation: dose, route of administration, pharmaceutical form and pack size. Unavailability does not always affect the entire product range of a medicine.

 

Actions and solutions

 

  1. Multi-angle approach: legislation and actions in the field

The FAMHP is investing in a more efficient and effective approach to address unavailability of medicines.

 

Unavailability Working Group (°2013) with representatives from:

  • the FAMHP;
  • pharmacists (APB, OPHACO);
  • hospital pharmacists (ABPH/BVZA);
  • the wholesale distributors (NVGV, OPHACO);
  • the pharmaceutical industry (BACHI, Medaxes, pharma.be);
  • the parallel importers and parallel distributors (BAPIE);
  • the health insurance funds (NIC);
  • patients (LUSS, VPP);
  • NIHDI;
  • FPS Economy;
  • the policy unit.

 

This working group looks for ways to systematically address unavailability of medicines. Consideration is given both to possible solutions when unavailability occurs and to measures to prevent unavailability.

 

  1. Decision tree

The FAMHP experts use a decision tree to analyse every reported unavailability by the marketing authorisation holder or parallel distributor in order to estimate the impact on public health. This enables the FAMHP to take appropriate measures to minimise the impact of unavailability on patients. The assessment is based on specific criteria that take into account the duration of unavailability, the number of alternative medicines available, and the indication.

 

If the unavailability may involve risks, the FAMHP will contact the marketing authorisation holder or parallel distributor of the relevant medicine for more information. The FAMHP also contacts marketing authorisation holders or parallel distributors of alternative medicines so they may anticipate a possible increase in orders.

 

For 60% of unavailable packages, the expected duration of unavailability is less than one month or there are at least three alternatives that simultaneously meet the following criteria:

  • the same active ingredient;
  • the same desired dose;
  • the same route of administration;
  • the same pharmaceutical form for certain medicines (same pharmacological characteristics, e.g. extended or modified release).

Of all reported unavailability, 10% can be resolved by one or two alternatives that meet the above criteria.
In 5% of the cases, it concerns a medicine that is not essential for life.

The other unavailable packages (25%) could potentially cause problems with a substantial impact for patients.

Approach

  1. After analysis by experts, the unavailability can be resolved by an alternative with a different active ingredient or a magistral preparation (13%). The route of administration may also differ.
  2. The FAMHP may grant a derogation at the request of a company. The company may then temporarily import batches of the same medicine into Belgium. Patients have access to the medicine at the same price and with the same reimbursement conditions. This is the case for about 4% of unavailable packages. This package may display a language other than our official languages.
  3. If no equivalent medicine is available in Belgium (licensed or marketed), the pharmacist may import a medicine on the basis of a medical prescription and a doctor's certificate (Article 105 of the Royal Decree of 14 December 2006). This temporary import ensures that the patient has his/her medicine with the same active substance, but with a leaflet and box in a language other than the Belgian official languages. In these cases, it is likely that the patient will have to pay a higher price for the medicine. This is the case for about 1.5% of unavailable packages.
  4. Cases of unavailability of medicines for which there are no alternatives are known as cases of critical unavailability. This concerns about 6.5% of unavailable packages. In that case, a Task Force with experts from the FAMHP, INAMI-RIZIV and external experts is convened. This task force makes recommendations to help healthcare practitioners. The recommendations are published on the FAMHP website and on PharmaStatus. They are also made available through the national authentic source for medicines (SAM) portal for integration into doctors' and pharmacists' software.

 

In the event of critical unavailability of a medicine, the following options are discussed:

  • rationed use of the available stock of the medicine such as prioritising certain indications of the unavailable medicine or restricting distribution;
  • possible solutions in case of complete unavailability, such as alternatives for certain indications.

 

The FAMHP is aware that a change in treatment is not without risk, such as confusion, errors, under- and over-dosing when switching to another medicine (different brand name, different packaging, different colour, etc.) or when importing a medicine (different packaging, different language, etc.). Therefore, that change must be made under the supervision of a doctor or pharmacist; they are the key to effective treatment.

 

PharmaStatus

PharmaStatus improves the exchange of information to healthcare professionals and patients on the availability of medicines. For each case of unavailability, you will find the results of the analysis of the criticality of each unavailability and the experts' recommendations. You will also find additional explanations (by hovering over a word) in patient-friendly language about the impact and reason for unavailability. Any citizen can sign up to (a group of) medications to be notified of changes in availability via automatic emails.

 

This online platform facilitates the reports that companies are required to send by law (start or discontinuation of commercialisation, unavailability). Since April 2021, pharmacists and wholesaler-distributors have been able to contact the marketing authorisation holder or parallel distributors through PharmaStatus in the event they suspect a shortage or supply issue to occur. The FAMHP follows up on these reports and is therefore better informed of the situation in the field.

 

  1. Authentic Source for Medicines (SAM)

Information on aspects including criticality, recommendations, and alternative solutions are integrated into the Authentic Source for Medicines (SAM) to enable doctors and pharmacists to stay informed of availability of medicines and possible solutions at the time of prescribing or dispensing.

 

  1. Additional measures

The Law of 20 December 2019 provides for additional measures to limit the unavailability of medicines. The law clarifies the obligation of pharmaceutical companies to supply wholesaler-distributors (within the scope of their own special obligations) and pharmacists within three working days.

 

Partial or interrupted deliveries are automatically regarded as unavailability and must be reported to the FAMHP. A report must clearly describe the cause and duration of the unavailability.

 

Most of the provisions of this law will be elaborated further through implementation decrees, more specifically:

  • transparency of stock (of wholesaler-distributors);
  • performance restriction in the case of unavailability;
  • substitution by the pharmacist in the case of unavailability;
  • expansion of means of import via Article 105 of the Royal Decree of 14 December 2006;
  • compensation of the patient's additional expenses (in cooperation with NIHDI).

 

  1. Stock Monitoring Tool

In May 2021, the FAMHP launched a Stock Monitoring Tool. During the COVID-19 pandemic, accurate monitoring of stocks of medicines proved particularly useful. It enabled the FAMHP to act proactively and find solutions in a timely manner. This monitoring was carried out manually until May 2021, but the processing of the data is now automated through a new Stock Monitoring Tool. Stocks of medicines that are becoming too low are therefore more readily spotted and, in the event of issues, there is also greater visibility of the availability of alternative medicines. This tool is used for medicines that play an important role in the fight against COVID-19.

 

  1. European consultation

The unavailability of medicines is not a purely an issue in Belgium; it is also a Europe-wide issue, and even a global issue. For this reason, systematic consultation and information exchange takes place at European level to find common solutions.

 

Interruption and discontinuation of commercialisation

 

Causes of interruption or discontinuation of commercialisation of medicines

Commercialisation may be interrupted or discontinued as a result of:

  • unavailability of the active ingredient;
  • unavailability of an excipient;
  • long-term production issues;
  • commercial reasons;
  • insufficient demand;
  • replacement with a different medicine/package;
  • force majeure;
  • other reasons;
  • discontinuation of reimbursement;
  • suspension of the authorisation;
  • withdrawal of the authorisation.

 

Number of interruptions and discontinuations of commercialisation

Reports of medicine packages whose commercialisation was interrupted or discontinued represent, on average, five per cent (data in 2021) of the total number of packs marketed in Belgium.

 

Reports of an interruption of commercialisation are published on PharmaStatus until they become available again. Reports of a discontinuation of commercialisation are published on PharmaStatus for one year.

 

Reports of unavailability are made for each presentation: dose, route of administration, pharmaceutical form and pack size. Unavailability does not always affect the entire product range of a medicine.

 

Solutions and actions

If the marketing authorisation holder or parallel distributor decides to withdraw a product from the Belgian market, the product will no longer be available in Belgium. The FAMHP does not have the authority to force a company to market a medicine. However, the FAMHP evaluates every report of interruption and discontinuation of commercialisation to assess the impact on public health. This is done on the basis of a decision tree. It enables the FAMHP to take appropriate measures to minimise the impact of interruption or discontinuation of commercialisation on patients. This assessment is based on specific criteria that take into account the number of market players, the number of alternatives available, and the indication.

 

If the interruption or discontinuation of commercialisation may give rise to risks, the FAMHP initially contacts the marketing authorisation holder or parallel distributor of alternative medicines so they may anticipate a possible increase in orders. If this is not possible, experts are contacted, and they check whether the interruption or discontinuation of commercialisation can be resolved by an alternative with a different active substance or by a magistral preparation. The route of administration may also differ.

In the event of interruption or discontinuation of commercialisation of medicines for which there are no or insufficient alternatives, the FAMHP will take further steps, such as entering into dialogue with the marketing authorisation holder or parallel distributor to ascertain whether they can nevertheless remain on the market or whether they are prepared to sell their MA. The FAMHP also checks the commercialisation status in other (European) countries and may contact marketing authorisation holders or parallel distributors to ask whether they wish to enter the Belgian market. The FAMHP may also approach raw material manufacturers and ask them to market the raw material in Belgium.

 

The FAMHP is aware that a change in treatment is not without risk, such as confusion, errors, under- and over-dosing when switching to another medicine (different brand name, different packaging, different colour, etc.). Therefore, that change must be made under the supervision of a doctor or pharmacist; they are the key to effective treatment.

 

Reporting a change regarding availability

Holders of a marketing authorisation (MA), registration, authorisation for parallel import or a temporary authorisation for use and parallel distributors are required by law to report any information concerning:

 

  • placement on the market (start of commercialisation );
  • the permanent discontinuation of commercialisation
  • temporary discontinuation of commercialisation (temporary unavailability and interruption of commercialisation )

of medicines to the FAMHP via PharmaStatus.

 

Further information about the reporting procedure.

 

Statutory basis

  • Article 6, section 1e, paragraphs one and two of the Law of 25 March 1964 on medicines.
  • Articles 113, section 3, and 238, section 3, of the Royal Decree of 14 December 2006, part 1 and part 2 on medicines for human and veterinary use.
  • Articles 2, 4 and 5 of the Law of 20 December 2019 amending various laws concerning shortages of medicines.

 

Contact

For questions regarding the unavailability or commercialisation of a medicine: supply-problems@fagg-afmps.be.

Last updated on 25/03/2022