LSHC Horizons Brochure 2024 - Flipbook - Page 47
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Transactions
47
Strategic considerations in view of a (proposed) broader
Bolar exemption in EU
Recent European Commission (Commission)
proposals, including a broadening of the socalled ‘Bolar exemption’, would substantially
change various incentive schemes related
to medicinal product approvals in some
jurisdictions, with the stated goal of increasing
competition from earlier market entry of
generic/biosimilars. The proposal raises a
number of considerations for stakeholders
thinking strategically about where to invest
in manufacturing, clinical trials sites, and/or
contractor relationships in European Union
(EU) Member States and neighboring markets,
including the United Kingdom, and the impact
these may have on their agreements and the
prospect of future litigations. Companies
engaged in early development programs should
consider the impact the proposals could have (if
implemented) on their R&D and future launch.
The proposed exemption provides that covered
activities (studies, trial and other activities
conducted to generate data that might
otherwise infringe a patent or supplementary
protection certificate (SPC)) must be conducted
exclusively for the listed purposes (to generate
data for an application for (1) an MA of generic,
biosimilar, hybrid or bio-hybrid medicinal
products, (2) health technology assessment
(HTA), or (3) pricing and reimbursement),
as well as the offer, manufacture, sale,
supply, storage, import, use and purchase of
patented medicinal products or processes.
Katie McConnell
Partner
London
The exemption expressly excludes placing the
resulting medicinal products on the market,
but the proposal that test product generated
during the regulatory approval process may
be used for commercial purposes after the
patent/SPC expiry. An expanded exemption
could thus make the impacted jurisdictions
more attractive as manufacturing locations for
generic/biosimilars.
The proposed exemption makes clear that
activities conducted to generate data for HTA
and pricing and reimbursement are expressly
permitted. Under current national laws in
certain Member States, the submission of
pricing and reimbursement data is sufficient
to trigger the granting of a preliminary
injunction (PI). A change in the Bolar
exemption could impact the PI landscape,
as well as making these jurisdictions more
attractive for administering clinical trials
and generating other types of data. Another
consideration, depending on how the proposals
are implemented, is to what extent activities
performed within a jurisdiction could be used
for the purpose of seeking regulatory approval
in jurisdictions outside of the EU, which
again, could encourage investment in local
manufacturing and clinical trials sites.
Penny Powell
Partner
London
Finally, the proposed exemption expressly
includes activities performed by third party
suppliers and service suppliers. With regard
to these covered beneficiaries, the proposed
framework would likely provide more
legal certainty for contract manufacturing
organizations (CMOs) involved in generic/
biosimilar production. This could provide
welcome relief to parties negotiating
contracts related to their active
pharmaceutical ingredients or other
essential product components.
While implementation of these specific
proposals is subject to further policy
advocacy and may still be several years
away, prudent stakeholders should take
note because the underlying EU policy
goal of facilitating patient access to
innovative medicines through
pharmaceutical and patent reform
will likely remain.
Hein van den Bos
Partner
Amsterdam
