A study led by the Technopolisgroup policy consultants
has analysed the legislative proposals covering supplementary protection
certificates (SPCs) and the introduction of a unitary supplementary certificate.
The client - the European Parliament's Committee on Legal Affairs (JURI) - was
interested in analysing the potential impact of the European Commission`s
proposals for further developing the SPC system for accessing innovative
medicines within the EU.
The system remains complex
reminder: an SPC is intended to compensate for the sometimes long period
between patent application and market approval by extending market protection
by up to five years. Its further development is part of the reform of
intellectual property rights that was initiated by the European Commission on
27 April this year. In addition to the existing system of issuing national SPCs
for nationally authorised products, a centralised procedure for issuing
national SPCs will be introduced in some or all member states. There will also
be a standardised SPC for use throughout Europe, which will complement the
standardised European patent that has already been introduced. As combining the
procedures will also be possible, this means that there will be four ways to
obtain an SPC.
Simplifications are questionable
Technopolisgroup's consultants also concluded that the planned new system will
simplify the application procedure to be used for standardised SPCs by creating
a single administrative office for applications and payments, i.e. the EUIPO
(EU Intellectual Property Office). However, as the current system will be
maintained in parallel, the situation for non-standardised SPCs will remain
complex, as separate assessment notices for each country might result in
parallel appeal and objection procedures. There is also a risk that the
centralised procedure for national SPCs will lead to parallel positive and
negative assessment decisions, as the application requirements might differ in
the member states.
Fewer SPCs - more competition
positive effects are also conceivable. Prompt access to generics could be
improved if extended appeal options result in fewer SPCs being granted. It is
unlikely that the current national differences in handling SPCs will play a
significant role in the unequal access to innovative medicines. This is largely
determined by national market characteristics - i.e. market size, availability
of alternative treatments, pricing and reimbursement - and not by the SPCs.
Less can be more when it comes to intellectual property rights
study followed a similar line to a study commissioned by the Committee on the Future of
Science and Technology in the European Parliament that surprisingly was not
presented for discussion. This has caused a bit of a political stir at Brussels
level in recent weeks. The tenor of the "Improving access to medicines and
promoting pharmaceutical innovation" study was that the generous
intellectual property rights granted for developing medicines do little to make
it easier to access medicines in Europe. Prepayment models, joint procurement
or publicly funded research would be more effective.