What a year 2012 has been for the Life Sciences industry!
For once, there has been no shortage of developments when it comes to regulatory, including the new pharmacovigilance legislation – the biggest change to the regulation of human medicines in the EU since 1995.
The European Commission amended its regulation on patient information, and also put forward new regulations for medical devices. Then there was the economy, forcing companies to seek additional efficiencies in the way they operate whilst facing the patent cliff and shrinking healthcare budgets across the board.
The pharmacovigilance legislation has enjoyed some very good coverage during 2012 – for good reason! Not just in the days leading up to the deadline for the initial implementation phase – July 2, 2012, by which companies had to electronically submit to the European Medicines Agency (EMA), information on all medicinal products for human use authorized or registered in the EU, using the new electronic exchange format XEVPRM, but also throughout the year.
No conundrum! Just a corrigendum to watch for
Somewhat less limelight was left to the corrigendum to the amended European Commission’s proposal for a regulation regarding information on medicinal products subject to medical prescription. Adopted by the Commission in mid-2012, it amends the Regulation (EC) No 726/2004 and it deserves some attention as well.
After 2012 (that is, let’s hold our breath!), the EMA is set to launch a brand-new European medicines web portal, which is planned to link to the national medicines web portals. Whilst the EMA’s website already contains a wealth of information on medicinal products which are authorized in the EU, the new web-portal should contain at least links to the following (according to the amended proposal):
- the database on medicinal products (EudraPharm)
- the Eudravigilance database
- the EudraGMP database
- the Orphanet portal for rare diseases and orphan drugs
- the Health-EU portal
In recognition of the increasing multilingual requirements of the pharmaceutical industry in Europe, the amendment now specifically says that the EudraPharm database on medicinal products – available in 24 EU and EEA languages – needs to allow searches in all official languages of the Union. The information contained in this database continues to be in the languages of Member States where medicines are authorized.
EMA’s big picture – 2016-2021
All this needs to be seen in the framework of the overall strategy that the EMA has laid down. They estimate that some 700 submissions regarding information to patients on medicines authorized centrally by the EMA, will need to be checked annually between 2016 and 2021. This should ramp up to 800 a year from 2019.
As always, there is a cost attached to this. Applications might be submitted in languages other than English. So they will need to be translated into English for the EMA’s review. Once completed, their assessment will have to be translated back into the original language.
This is the “established model.” According to the EMA, however, “reality may demonstrate that another model should be followed in order to ensure more efficiency in working directly in original languages, with the use of inhouse resources for the pre-control of the information and, therefore, not using translation.”
At any rate, the related EMA budget for the years 2016-2021 includes some interesting numbers with regards to the corresponding costs of translation, which are based on a standard 7-page document:
But, things may still turn out a little different. In their recent news, the EMA announced a review of their operations and preparation for reorganization during 2013. The focus, as is the case in commercial organizations these days, is on “increasing the efficiency of its scientific activities and information- and communication-technology operations.”
This should be another interesting year ahead for the Life Sciences industry!