What regulations say about drug shortage
Recent news say that Competent authorities for medicinal products in Europe and United States are preparing themselves to face one of the most important effect of the lock-down to all activities due to the coronavirus spreading: the possible drug shortage. And not only of those medicines currently used off-label or under clinical trial for the treatment of patients affected by the disease – remdevisir and tocilizumab – but also all other products, having apparently nothing to do with COVID-19.
The problem was raised – back when no one would have imagined – by United States, soon after the closure of all activities in the affected areas by the Chinese authorities, including pharmaceutical manufacturing sites.
China, we all know, as well as India is the main active substance manufacturer worldwide, and United States – that depend on it for almost 15% – has legitimately feel the need to guard themselves from any difficulty that could create problems to the production and distribution chain of medicines in the country.
To this aim, they identified about 150 medicines at risk of shortage, inviting manufacturers to keep their supply chain under constant monitoring, with special reference to active substances, finished products, and any ingredient for which a potential impact can be expected due to the current situation.
The European Medicines Agency (EMA) has also released a communication on the potential impact of COVID-19 on the supply of drugs in the European Union. Together with the national regulatory agency network, EMA is monitoring the situation: for the moment no drug shortage or supply disruptions were reported, however such circumstances cannot be excluded, should the health emergency continue.
For this reason, the European Union organised an Executive Steering Group on shortages of medicines caused by major events, that has already met to discuss the measures required to face the effects of the epidemic on the supply of medicines in the EU, coordinating any action necessary to protect patients’ health in case of shortages at European level.
Possible actions include inviting manufacturers to increase stocks or products and materials supply. Other actions already taken include sensitising pharmaceutical companies, through trade associations, so that they assess the potential impact of the quarantine in China and elsewhere on the supply of medicines. EMA also started the review of all information on the manufacturing of human and veterinary drugs authorised centrally to better identify the products at higher risk of shortage and disruption. Finally, national regulatory agencies are collecting information from marketing authorisation holders and manufacturers in the respective Member States.
Marketing authorisation holders were also reminded of the obligation to report any shortage to the authorities. How?
In Italy, the obligation for holders to inform the authorities in case of shortage or temporary or final cessation of the marketing of a medicinal product is regulated by law-decree 30 April 2019, no. 35 (Emergency measures for the health service of the Region Calabria and other urgent measures for health), in force as of 3 May 2019.
«In case of disruption, either temporary or final, of the marketing of a medicinal product on the national territory – states article 34, comma 6, of Leg.Dec. no. 219/2006, as amended by the above mentioned decree – the MA holder shall inform AIFA. This communication shall be done no less than four months before the disruption of the product marketing, except for disruptions due to unforeseen circumstances.».
Delays in the supply of active ingredients and excipients as well as the increased demand of a medicine caused by shortage of equivalent or analogous medicines or for special contingent situations are classified as “unforeseen” and would seem the more applicable to the current situation.
For this reason, in informing AIFA about the shortage of a medicinal product, its holder shall always report the reasons determining the marketing disruption, including a detailed description of the event or reasons to allow an appropriate evaluation of the “unpredictability” of the circumstances. Supporting documents can also be enclosed, such as a declaration by the manufacturer of the raw materials.
Other information to be reported in the communication includes, of course, all details regarding the medicine under shortage (trade name, active substance, pharmaceutical form and dosage, pack size, MA number and holder business name); date of beginning of the marketing disruption or of the anticipated shortage; distribution channels affected by the marketing disruption; any indication about the existence of equivalent and/or alternative medicines; any information on the use of the medicine; indications that the holder also have MAs of an analogous medicine abroad; indications that the MA holder is available for the importation from abroad; indications on any possible impact of the marketing disruption in other countries; information on the quantities of stocks at the date of the communication; sales data (on a monthly basis) for both retail and hospital channel, regarding the previous 36 months; and indication of a company contact point, including an e-mail address (certified e-mail, PEC), and a direct telephone number of a contact person.
In their communication to the Competent Authority, the MA holder should also include the expected duration of the disruption and the presumed date of the return of the product on the market, as well as any relevant update, and an assurance about the organisational and logistic capacity to manage the supply requests for the period corresponding to the shortage notice.
However, the COVID-19 emergency is an unforeseen as well as a particularly extraordinary case, and it will probably be necessary to wait for further provisions from the authorities and any other action they might take.
Written By: Maria Pia Felici
