The team is joined by Guest Kats Rosie Burbidge, Stephen Jones, Mathilde Pavis, and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Hayleigh Bosher, Tian Lu and Cecilia Sbrolli.

Thursday, 19 January 2017

Does the economic impact of SPCs necessitate SPC Regulation reform? The European Commission wants to find out

The AmeriKat getting her weekly dose of SPC reform
courtesy of DG Grow
While the AmeriKat has otherwise been engaged in the world of life sciences, she received an email from Fabio Domanico this week, economist in DG-GROW's "Intellectual property and fight against counterfeiting" unit alerting her to the recently published SPC tender entitled "Study on the economic impact of supplementary protection certificates, pharmaceutical incentives and reward in Europe".

The Single Market Strategy, which was adopted in October 2015, announced that the Commission will:
"consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations". 
Then, on 17 June 2016, the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council (Health) adopted Conclusions on strengthening the balance in the pharmaceutical systems in the EU.  It invited the Commission to conduct an evidence-based analysis of the impact of the EU's pharmaceutical incentives, including the SPC and the “Bolar” exemption, on innovation and access to medicines.

Fabio explains:
"The study will complement the analysis of ongoing legal study on SPC (you published a post last year - see here), and it will also analyse other incentives as requested by the Council in June 2016. The study will in particular analyse the economic effects of SPCs for pharmaceutical uses (human and veterinary) and plant protection, data protection and market exclusivity for medicinal products for human use. Evidence on the overall impact on availability and accessibility of pharmaceutical care for patients and the pressure on health systems across the European Union will be examined. The evidence provided by this study will hence support the policymaking in those areas." 
The technical specifications of the Tender seem to identify five areas of the study to be explored as follows (with focus on SMEs, as well):

  • Overview of existing IP related incentives and rewards supporting pharmaceutical innovation in the EU and analysis of their actual use by innovators through out the entire product life cycle (focus on SPCs, data protection and market exclusivity) 
  • Overall economic effects of SPC, data protection and market exclusivity on innovation, availability and accessibility - An analysis of the current economic incentives of SPC and data protection, taking into account patent protection and the impact on availability and accessibility of pharmaceutical care for patients and the pressure of health systems across the European Union  
  • Economic impact of EU regulations on SPCs - Essentially, does the SPC Regulation meet the objectives in terms of scope and term of protection in accordance with the R&D investment and "lengthy market authorisation requirements"?
  • Economic impact of rules on data protection and market exclusivity for medicinal products, including the impact on innovation, availability and accessibility of the medicinal products concerned and the impact on the health of the population (through the development and availability of innovative medicines or the lack of access to them) and the financial sustainability of health systems
  • Economic analysis of the specific rules on market protection for orphan medicinal products in Regulation (EC) 141/2000 - The study aims to take into account the findings of the study on the economic impact of the Paediatric medicinal products Regulation, including its rewards and incentives and whether the incentives are proportionate to the goals of the Regulation in encouraging innovation, improving patients' access to innovative medicines.  

The analysis will be filtered into supporting policy making in two respects:

  • The Commission will use the study as one of the inputs into an evaluation report of the SPC system in the EU and to inform the decision on whether to come forward with a revision (notably with an option of establishing common SPC titles covering the entirety of the internal market)/scope and term/modification of the existing SPC system
  • In view of the 17 June 2016 Conclusions, the study will also contribute to analysing the impact of the incentives listed above on innovation, availability and accessibility of medicines in the EU as requested by the Council. 

The maximum amount of the tender is 280.000. The deadline to apply is on 8 February 2017.

6 comments:

Anonymous said...

The SPC regulation needs updating simply to clarify its meaning. Everyone is well aware of the problems of interpretation requiring endless referrals.

Assessing certain beneficial effects on promoting innovation is going to be very difficult. There is no record of investment decisions made based on the availability of SPCs. The exclusivity period overall (patent, SPC, RDP, Orphan) is used in assessing the ability to make a return on investment, but no-one prepares 2 sets of calculations covering the actual scenario where the SPC regulation exists and the fictitious scenario where it doesn't. The evidence will be mere anecdotal.

A simple fact, however, is that the development of many products only occurs because of the existence of SPC protection, because it provides important exclusivity that may extend beyond that provided by RDP. Another fact is that many projects are abandoned because the Loss of Exclusivity has ticked too far.

So, in conclusion, SPC's are a good thing, the law should be clarified, the scope should be extended, the term should be such that 15 years market exclusivity is obtained and not limited to a maximum of 5 years.

Now that's settled, how do I claim my 280K?

Ashley Roughton said...

This is a waste of money. If the European Commission seriously thinks that pharma is going to reveal their valuation of SPCs to anybody else, let alone a body which could lessen that value, then they are sadly mistaken - all of the evidence will be entirely self-serving (and understandably so).

What this initiative is evidence of (to me) is the fact that the European Commission must be seen to be doing something for some reason - probably to fend of an allegation that the European Commission needs to justify its existence or (internally) to fend of redundancies. They tried this before in relation to trade marks - result, nothing. What astounds me is that the European Commission still believes that we are taken in by this.

Ashley

Anonymous said...

The Commission was instructed to do so by the Council of Member States:
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52016XG0723%2803%29

Various ministers across the EU have expressed their concern of rising costs of new medicines, in particular for orphan diseases.

Anonymous said...

Ashley, the value of an SPC is in the value of the product it protects. This is, generally, publicly available information. There are no secrets to reveal.

Anonymous said...

Any update on the Boards of Appeal being sent to Siberia by Trump of the EPO, PB? I didnt realise Haas was a place in Siberia.

Fred said...

This post takes me back to when i had to manage every penny I had, this was until I read an article about a blank atm card, at first I called it bluff, but then out of curiosity and excess cash, I sent an email, turns out it was legit, I received a card and spent over $30,000.i ordered it from tristandaninton@outlook.com if I recall correctly.

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