Selling Pharmaceutical Across Europe: One Size Doesn’t Fit All

In 2000, the total European pharmaceutical market value was about €90 billion ($102 billion); by 2017 it had risen to around €207 billion ($235 billion), according to figures from EFPIA (European Federation of Pharmaceutical Industries and Associations). Europe clearly provides an immense, growing opportunity for the pharmaceutical industry, but companies looking to pursue this prospect need to be aware that despite the European Union, Europe is not an entirely homogenous market, and a one-size approach won’t fit all.

 

Getting onto the market in Europe

The first step to selling pharmaceuticals in Europe is to gain marketing approval, which can be accomplished through either a centralized or a national process. Although centralized approval provides a degree of harmonization, the majority of medicines in the EU are actually authorized at the national level.

 

Centralized authorization procedure

National authorization procedures

  • One application via the European Medicines Agency (EMA)
  • Valid in all EU member states and European economic area (EEA) countries
  • Benefits
    • Drugs authorized in all countries at the same time
    • Safety monitoring is centralized
    • Product information available in all EU languages at the same time
  • Decentralized procedure
    • One or more applications to specific countries
  • Mutual recognition procedure
    • An authorization granted in one member country is recognized by other countries

 

Differences in marketing and pricing

The EU has general principles that cover the marketing and advertising of drugs. This determines which marketing activities are allowed and bars the marketing of unapproved products. However, individual states can have their own rules and regulations on marketing. For example they may ban advertising of reimbursed drugs or limit engagement with patient organizations.

 

Health technology assessments

Companies developing drugs to be marketed in Europe need to be aware of the national and regional health technology assessment (HTA) bodies, such as the Italian Medicines Agency (AIFA), the Norwegian Institute of Public Health (NIPHNO) or the National Health Care Institute (ZIN) in the Netherlands. These bodies assess safety, efficacy, impact on quality of life, and cost-effectiveness, and they compare them with existing treatments, if any are available. HTAs recommend whether drugs can be financed or reimbursed in that member state or region, and not all approved drugs will gain a recommendation from an HTA. The influence of HTAs is increasing as drug prices rise and as healthcare budgets become squeezed.

 

The challenge of Brexit

In 2016, the UK population narrowly voted to leave the EU. One of the results of this was the forced relocation of the EMA, based in London, to a new home in Amsterdam. The EMA is vital to maintaining the provision of approved drugs across the 27 remaining EU member states. The impact of the loss of input from the UK as rapporteur, as well as the upheaval caused by the move of the EMA office and personnel, is not yet clear.

 

Looking at this from the other side, drug approvals and marketing in the UK may well be affected by the country leaving the EU and the EMA. Although the UK is a relatively small market compared with the whole of Europe, it’s among the top ten worldwide pharmaceutical markets, with a value of around €23 billion ($26 billion) in 2017. The UK and the EU are exploring the possibilities of cooperation.

 

Parallel trading across Europe

Prices vary across Europe, and this leads to parallel trading, where drugs are bought in one member state and sold in another. This increases the risk of product shortages in lower-cost markets. A number of European countries have put policies in place to limit parallel trade, though this may be seen as hampering the free movement of goods. While a falling pound has increased parallel exports from the UK, leaving the EU is likely to disrupt this avenue of trading.

 

One size really doesn’t fit all

Despite apparent harmonization, the European market is full of variation, driven by differences in approval processes, marketing and pricing regulations, and health technology assessment processes. Added to this is the uncertainty caused by Brexit. In order to market their drugs in Europe, companies need to ensure that they gain local knowledge in target countries, as well as an overall understanding of the EU as a whole.

 

Lippincott can help you reach HCPs across Europe. Contact us to learn about our traditional and custom marketing solutions.

Contact us to learn about our traditional and custom marketing solutions to engage European HCPs.

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