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NUMBER 12
25 JUNE 20 2 1
With updates on Covid-19
News, projects and data from the
pharmaceutical industry, institutions,
associations, patients, doctors, stakeholders,
the Confindustria network, EFPIA and IFPMAT A B L E O F
C O N T E N T S
Institutional News . . . . . . . . . . . . . . . . .3
Focus On - National and European healthcare institutions . . . . . . . . . . . . . . 10
Working on . . . . . . . . . . . . . . .13
Info Data . . . . . . . . .. . . . . .14
. . . . . . . . . . . . . . .15
Efpia / Ifpma
. . . . . . . . . . . . . . 16
Confindustria
. . . . . . . . . . . . . 17
Pharmaceutical Companies NewsCollection of the principal national,
regional and European institutional news
I N S T I T U T I O N A L
N E W S
National
23 Decree Law 80 of 9 June 2021 (aka Recruitment Decree Law)
"urgent measures for improving the public administration’s
22 Decree Law 59 of 6 May 2021 on the institution of
J U NE JUN a fund complementary to the PNRR -After the
2021 operating capacity for purposes of implementing the National 2021
Senate's green light, the Decree Law will be
Recovery and Resilience Plan and improving the efficiency of examined by Chamber of Deputies' Budget
the judiciary system" (2272). The decree, approved in the Committee in the current week (C. 3166 -
ALSO
Council of Ministers on 04 June (for the main measures see the ALSO
rapporteur Hon. D’Attis, FI).
COV ID-1 9
Council's press release ), together with the decree law on COV ID-1 9
During its passage through the Senate, the funds
temporary allowances for minor children (S.2267), follows envisaged for additional health measures, in
those measures already adopted for the governance of the addition to those in the PNRR, were confirmed.
PNRR and on administrative streamlining and constitutes the Revision of the programme title, now "Health, the
third pillar of a regulatory framework for the plan’s full environment, "biodiversity and climate". The
implementation. The text is being jointly examined by the appropriations envisaged in the forecasts of the
Senate's Constitutional Affairs and Justice Committees Ministry of Economic Development and the
(Rapporteurs Valente, PD and Caliendo, FIBP-UDC) that will Ministry of Universities and Research were
conduct a series of hearings. confirmed.
Rare diseases and orphan medicines (S. 2255) Consolidated
23 text approved by the Chamber of Deputies and the related On the question of testing, tracking,
J U NE 22
2021 bills S.146 and S.227 ) - Consolidated version, together with J U NE surveillance and sequencing to combat the
some draft laws on the same subject have been assigned to 2021 pandemic and Covid-19 vaccination for minors,
the Senate's Health Committee - Rapporteur Senator Binetti the Senate’s Health Committee conducted
(FIBP-UDC), which will begin the examine the text in the informal hearings with representatives from the
current week. The measure before the Social Affairs COV ID-1 9 Health Ministry and the National Institute of
Committee of the House was unanimously approved by all Health Institute (see video recording ).
groups.
22 A meeting took place between President Draghi and the European draft law 2019-2020 (S.2169 ) - In this
J U NE President of the European Commission Ursula von der Leyen, 22 current week, the EU Affairs Committee of the
2021 JUNE
during which the Commission’s approval of Italy’s PNRR 2021 Senate, will discuss the merits of proposed
"Tomorrow Italy" (link to press conference) was officially amendments to the bill. Proposed amendments
announced. (signed by Mixed Group -Leu, Mixed Group, M5S),
ALSO
COV ID-1 9 on the abolition of the extension (art. 28), added
by Chamber of Deputies, regarding the entry into
force of prohibitions on animal experimentation
22 Decree Law no. 77/2021 PNRR Governance and first were set aside for further examination. On this
J U NE simplifications - The Constitutional Affairs and Environment matter some recommendations (signed by FIBP-
2021
Committees of the Chamber of Deputies, having completed a UDC, PD, LEGA) were approved in the Committee,
large number of hearings, have started to examine the especially for the inclusion into the proposed
measure ( C. 3146 – Rapporteurs Hon. Calabria, FI and Hon. European Law 2021 to be submitted to the two
ALSO Morassut, PD). Confindustria figured among the subjects heard, Houses, with regard to specific provisions aimed at
COV ID-1 9
as well as the main trade unions and the Conference of the resolving infringement procedure no. 2016/2013
Regions (at the following link all the documents filed). and providing adequate financing for the
The first part of the decree law regulates the organization of development of alternative approaches to the use
governance for the application of the decree. The second part of animals (see recommendation also on primary
introduces some initial simplifications for implementing some healthcare).
of the Plan’s projects, in the fields of: healthcare buildings for
the Health Ministry; application of negotiated programming 22 The Minister of Health Ordinance published in the
J U NE
institutions and rules governing institutional development 2021 Official Gazette (no. 148 of 23 June 2021) removes
contracts regarding programmes within the competence of the the mask requirement in outdoor spaces in the
Health Ministry; procedures for evaluating research projects; «white area» from 28 June 2021 to 31 July 2021,
strengthening substitute powers and rules on tacit consent. with some exceptions.
COV ID-1 9Collection of the principal national,
regional and European institutional news
I N S T I T U T I O N A L
N E W S
National
Among the chosen amendments, those on: the
21 Decree Law: gradual resumption of economic and unification of two funds for innovative
J U NE social activities (no. 52 of 22 April 2021) - After
2021 medicines and innovative oncological
definitive approval by the Senate, the law converting
medicines; compulsory licencing; changes to the
the decree into statute law and the consolidated text
regulations of the Fund for the transfer of
of the decree with changes made were published in
technology and of the Enea Biomedical Tech
the Official Gazette (No. 146 of 21 June 2021)
COV ID-1 9 Foundation ; individual data in anonymized
Among the main measures of interest can be
format on medicinal product consumption; the
mentioned the extension to 31 December 2021 of
distribution of medicinal products;
certain deadlines concerning the state of emergency
administering Covid vaccinations by
as regards: therapeutic plans; flexible working;
pharmacists; a tax credit for pharmaceutical
distributing medicinal products to patients. Among the
distributors (see link to the draft of the selected
recommendations the Government accepted one
amendments on the health articles 26-35). The
signed by FIBP-UDC on the matter of a plastic tax.
Budget Committee does not have the decree law
tabled for this week’s agenda.
18 Press conference of the President of the Council
J U NE Draghi with the Minister of Health Speranza and the
2021 extraordinary commissioner Figliuolo, during which
The Premier Draghi signed a DPCM dated 17
some clarification on Covid vaccination was provided 17 June 2021 on the Green Pass, published in the
(link to the video). Among the questions touched on: J U NE
2021 Official Gazette (No. 143 of 17.06.2021) - the
the importance of vaccination; the efficacy and safety
COV ID-1 9 measure defines procedures for issuing the
of heterologous vaccination; “white areas” (minor
digital COVID -19 Green Certificates to be used
Covid restrictions) in most of the country; data on the
for participation in public events, access to
vaccination campaign.
COV ID-1 9 residential care homes and nationwide
travel. With the signing of the Decree the
18 The Minister Speranza recently signed two further conditions necessary for making the EU "Green
J U NE ordinances. The first ordered the transition of
2021 Pass” Regulations become operative, which from
Basilicata, Calabria, Campania, Marche, Sicilia and
July 1 will ensure the full interoperability of
Toscana and the Autonomous Province of Bolzano into
digital certificates within all the EU countries. Full
the "white area". The whole of Italy is, therefore, in
freedom of movement within the territory of the
the " white area" (area subject to the least restrictive
COV ID-1 9 European Union will be guaranteed to all in
Covid measures) except for Valle D'Aosta which was
possession of a valid national certificate.
left as a "yellow area". For the measures in force see
Government infographics. The second ordinance
regulates, from 21 June to 30 July, conditions for
The Health Minister’s Decree of 27 May 2021
persons entering Italy from abroad. 15 revamped the National Coordination Centre at
J U NE
2021 the Italian Medicines Agency responsible for
Decree Law no. 73/2021 Sustainment-bis (C.3132 -
17 territorial ethical committees for clinical trials on
J U NE rapporteurs: Hon. Buompane, M5S and Hon. Bitonci, medicinal products for human use and on
2021 Lega) - the parliamentary Groups chose from the
medical devices (Circular TR 21005S)
approximately 4 thousand amendment proposals COV ID-1 9
submitted to the measure (see complete dossier),
those to be submitted to Budget Committee of the
ALSO Chamber of Deputies' (at the following link the draft of Measures and documents of further interest on the
COV ID-1 9
the file of all selected amendment proposals). Coronavirus can be downloaded via the link: Covid-19
Page –Farmindustria’s site.
For the other updates on measures which are not strictly
Covid see link.
This report was closed with information available as at 4
p.m. on 22 June 2021I S I
T I T U T I O N A L N E W S
Regional
COVID Ordinance
COV ID-1 9
22 June - Updated summary of the contents of the regional 11 June - CALABRIA – Ordinance no. 41
ordinances in force, see link LAZIO – Ordinance no. 16
LOMBARDIA – Ordinance no. 779
21 June - SICILIA – Ordinance no. 71
10 June - ABRUZZO – Ordinance no. 36 with Annex A
19 June – CALABRIA – Ordinances nos. 42 and 43 SICILIA – Ordinance no. 68
18 June - BOLZANO PROVINCE – Ordinance no. 25 9 June - ABRUZZO – Ordinance no. 35 with Annex A
LIGURIA – Ordinance no. 26
17 June - SICILIA– Ordinance no. 70 SICILIA – Ordinance no. 67
VALLE D’AOSTA – Ordinance no. 281
5 June - VENETO – Ordinance no. 83
14 June - TRENTO PROVINCE – Ordinance no. 75
4 June - BOLZANO PROVINCE – Ordinance no. 24
13 June - SICILIA – Ordinance no. 69 TOSCANA – Ordinance no. 53
VALLE D’AOSTA – Ordinance no. 258
12 June - PIEMONTE - Decree no. 59
Conferences of Regions
24 June - Extraordinary meetings convened in respect of:
Conference of the Regions, which will examine the issues addressed by the Conference State-Regions and the Unified Conference;
State Regions Conference, whose agenda dwelt in particular on the understanding reached on a draft MEF (Ministry of the Economy and Finance)
Decree, together with the Health Ministry, on the distribution of the 2021 € 1000 budget among the Regions and the Autonomous Provinces to
reimburse expenses incurred in 2020 to procure individual protection devices and other health items relating to the current emergency;
Unified Conference will give its opinion, inter alia, on the conversion into law of Decree Law 9 June 2021, no. 80, containing urgent measures for
improving the administrative capacity of national and local administrations in relation to the implementation of the national recovery and resilience
plan and the efficiency of justice (A.S. 2272).
17 June
The Conference of the Regions approved:
• The understanding reached on MEF’s proposed allocation, as between the Regions and the Autonomous Provinces, of the fund to sustain economic
activities severely impaired by the current epidemiological emergency;
• The agreement concerning "the updating of the State Regions Agreement of 20 October 2015 in relation to the NHS unit transfer price between
health care organizations and Regions and Autonomous Provinces, of blood units, blood components and plasma derived products manufactured
in convention, as well as actions to promote exchanges between healthcare organizations within and between regions“;
• A decision on the understanding reached on a document entitled "guidelines for regional projects designed to trial new local health facilities" and on
the allocation for the 2020 budget year of resources aimed at strengthening primary healthcare was instead postponed.
The Unified Conference expressed a favourable opinion:
• on the draft to convert Decree 25 May 2021, no. 73 laying down: "Urgent measures relating to the emergency from COVID-19, for enterprises, work,
young people, health and the territorial services", and expressed its hope that the amendments proposed would be accepted (see link);
• on decree law 31 May 2021, no. 77 laying down: " Governance of the national recovery and resilience plan, and initial measures to strengthen
administrative structures and accelerate and streamline procedures", by proposing certain amendments to the text (see link);
• with recommendations on a guideline scheme for online access to public administration services as referred to in art. 64-bis of Legislative Decree
82/2005 (see Link).I S I
T I T U T I O N A L N E W S
Regionale
Other Regional Measures
21 June - EMILIA ROMAGNA - Publication of DGR 863/2021 - Tender to attract investments
18 June – ABRUZZO - Publication of DGR 218/2021 - 2021 pharmaceutical expenditure ceilings for single local health authorities.
Publication of DGR 240/2021 - Prescriptive appropriateness for biological drugs whose patents have expired. Publication of DGR
246/2021 – Computerisation of therapeutic plans for PHT (medicinal products for hospital use) subject to DPC distribution (via
private pharmacies)
18 June – VENETO - DGR 728/2021 – Implementation of the agreement for participation by specialist hospital doctors in the Covid
COV ID-1 9
vaccination campaign with Annex A
17 June – LAZIO - Publication DD 7347/2021 - June update of Covid Territorial Plan. MARCHE - Publication of DGR 14/2021 -
COV ID-1 9 Reprogramming POR ESF for Covid effects. PIEMONTE - Publication of DGR 2-3344/2021 - Second remodulation of the Covid hospital-
network reorganization. Publication of DD 823/2021 - 2021 Regional prevention plan
16 June – LIGURIA - Publication of DGR 374/2021 - Transposition of guidelines for resuming economic activities. TOSCANA -
COV ID-1 9
Publication of DGR 628/2021 - Agreement with parapharmacies for administering Covid vaccinations. UMBRIA - Publication of DGR
510/2021 - General Practitioner Agreement on Covid vaccinations
15 June – LAZIO - Publication of DGR 339/2021 - Maximum 2021 healthcare financing levels. Publication of DGR 341/2021 -
Guidelines for defining family caregivers,
15 June – VENETO - Publication of DGR 727/2021 - New testing and Covid screening and contact tracing plan with Annex A
COV ID-1 9
14 June – LOMBARDIA - Issue of DGR 4885/2021 - Supplements to developmental lines of Lombardia’s welfare-health system Annex
A. Publication of DGR 4832/2021 - Further resolutions regarding the international award "Lombardia is Research 2020"
11 June – LOMBARDIA - Publication of DGR 702/2021 - workplace vaccination agreement. MARCHE - Publication of DGR 662/2021 -
Guidelines for primary and secondary healthcare continuity Annex A. Publication of DGR 702/2021 – Transposition of indications on
COV ID-1 9
workplace vaccination
11 June – SICILIA- Publication of 18 May 2021 decree - 2021 Regional Prevention Plan. Publication of 18 May 2021 decree -
Operational Programme on structural measures and enhancing Regional Health System quality 2019-2021
10 June – LAZIO - Publication of DGR 327/2021 - Update of 2018-2023 strategic planning documents. Publication of PdL no.297 -
Provisions for scientific information on medicinal products. PUGLIA - Publication of DD 117/2021 - Update of PTR (regional
formulary). Publication of OFLR 15/2021 - Healthcare rationalization measures
10 June – LAZIO- Publication of 07 June 2021 Notice - vaccine obligations for health professionals and operators. PIEMONTE -
Publication of DGR 56 -3336/2021 – Transposition of agreement with pharmacies for administering Covid vaccinations
COV ID-1 9
9 June – TOSCANA Publication of DGR 582/2021 – Agreement with pharmacies for administering Covid vaccinations. Publication of
DGR 482/2021 - Continuation of Covid vaccination campaign. Publication of DGR 483/2021 - Workplace Covid vaccination campaign
COV ID-1 9
7 June – LOMBARDIA - Issue of DGR 4811/2021 - Developmental lines of Lombardia’s welfare-health system with Annex A
1 June – LAZIO Publication of DD 6144/2021 - Implementation of workplace vaccination agreement
COV ID-1 9 1 June – MOLISE - Publication of DGR 141/2021 - Participation of the region in the "Health Prevention Hub” project
For preceding measures refer to the link to the site dedicated to regional monitoring.
This report was closed with information available as of 4 p.m., on 22 June 2021I S
IT I T U T I O N A L N E W S
European (EU Council and Parliament)
22 Proposal for a Regulation to strengthen EMA’s mandate- Transparency on the development, purchase and distribution of
17 COVID-19 vaccines - the Petitions Committee of the European
J U NE the ENVI Committee of the European Parliament JUNE
2021 (Rapporteur MEP Gonzalez Casares - S&D, Spain), approved 2021 Parliament approved a proposal for a resolution calling for
its own report. All the compromise amendments were greater transparency on these aspects and support for
approved whereby ENVI proposed, inter alia, to set up a technology transfer to developing countries. The text, currently
interoperable digital European database to monitor unavailable, will be voted on in a plenary session in July. See
ALSO medicinal products’ demand and supply and any shortages. communiqué for further details.
COV ID-1 9
Following its expected approval in plenary sitting in July, the
ENVI Committee can begin negotiations with the EU Council.
The latter on 15 June approved its position, which 16 Special EP Committee on the fight against cancer - discussion on
substantially maintains the approach proposed by the J U NE the national programmes to control cancer with representatives
European Commission. 2021 from the WHO, DG SANTE and of the following member states:
Belgium, France, Czech Republic and Hungary.
At the following link the agenda, the video of the meeting and
Proposal for a Regulation on HTA - political agreement the speakers’ presentations.
22 reached between the negotiators of the Council and the
JUNE
2021 European Parliament. The official text is still unavailable, but
the European Parliament in its communiqué anticipated that Formal meeting between Health Ministers - adoption of the
it will include: Conclusions on access to medicines and medical devices.
15
• the introduction of safeguards to ensure that EU-level J U N E Among the questions touched on: dialogue between EU
joint clinical evaluations will be annexed to national 2 0 2 1 countries and industry; EU productive capacity; unmet medical
assessments and that Member States should report on needs; regulatory system; Real World Data; voluntary
their use in their respective HTA processes; cooperation on pricing and reimbursement; payment
• the creation of a network of stakeholders to facilitate mechanisms for innovative products; examination of joint
dialogue between Member States’ Coordination Group procurement’s added value.
and patients, developers, health professionals and ALSO
COV ID-19
Among the other topics addressed in the course of the meeting
consumers. (press release), in addition to the already mentioned proposals
on HTA and EMA: proposals for regulations on strengthening the
ECDC and the response to cross-border threats; COVID-19
21 Pharmaceutical strategy - publication of amendments (link) actions; the latest developments regarding AMR.
J U NE to the draft report by MEP Montserrat (PPE, Spain),
2021
Rapporteur for the lead ENVI Committee of the EP.
Amendments to the opinions of MEPs Botenga (GUE/NGL, EU Digital COVID Certificate - publication of the two constitutive
Belgium), Rapporteur for the ITRE Committee (link), and 15 Regulations in the EU Official Journal. The measures will apply
Regimenti (Lega/ID, Italy), Rapporteur of the JURI committee J U NE from 1 July 2021 to 30 June 2022. See Circular RI21022 for
2021
ALSO (link), were also published. further details.
COV ID-1 9 COV ID-1 9
See at the following links a summary note of the positions
taken by the rapporteurs and the shadow rapporteurs of the
various political Groups in the amendments propose in the TRIPS agreement waiver for COVID vaccines, treatments and
three Committees and a summary of the positions adopted 9-10 devices - the European Parliament approved in plenary session a
by various Italian MEPs. J U NE specific resolution on this question, in which support was
2 0 2 1 requested for constructive negotiations on a temporary waiver,
highlighting however that voluntary licenses represent the most
Intellectual property - Conclusions on the EU Action Plan effective instrument for facilitating production.
18
were adopted by the EU Council, The key role played by See Link to a note on the outcome of the vote, that saw
J U NE intellectual property and the importance of voluntary Parliament split into two factions. The amendment in favour of
2 0 2 1 solutions for sharing of IP, know-how and data relating to COV ID
-19
the waiver was in fact approved by a single vote.
COVID vaccines were highlighted.
The value of supplementary protection certificates (SPC) for
ALSO
innovation and investment in the EU was stressed, as well as Horizon Europe's partnerships - publication of amendments (link
C -19
OV ID
the importance of exploring more coordinated solutions to parts 1, 2 and 3) to the draft report of the Rapporteur of the lead
deal with the current fragmented SPC system in the EU. 9 ITRE Committee, MEP da Graça Carvalho (PPE, Portugal), on the
The JURI Committee of the EU Parlliament will also express J U NE proposal for a Regulation establishing the so-called joint
itself on the Action Plan - link to the draft report by Hon. 2 0 2 1 undertakings in the context of Horizon Europe, i.e., EU public-
Walsmann (PPE, Germany). private partnerships that would also include the Innovative
Health Initiative.
The European Parliament can give however only give a non-
binding opinion. The EU Council will, in fact, have the last word
on the Regulation..
The measures and documents of greatest interest on COVID-19 adopted by the Council and the European
Parliament can be found at following link. Other updates on measures that are not strictly COVID.
This report was closed with information available as of 12.00 on 23 June 2021I S
IEuropean (European Commission)
T I T U T I O N A L N E W S
22 The EU Commission gave its green light to Italy's Recovery 15 Communication “Drawing the early lessons from the
JUNE and Resilience Plan and adopted the “Proposal for a Council J U NE COVID-19 pandemic” that focuses on what has to be
2021 2021
COV ID-1 9
Implementing Decision on the approval of the assessment of improved and provides a snapshot of what needs to be
the recovery and resilience plan for Italy” and the acted upon as soon as possible, among which:
correspondent Annex . COV ID-1 9
• designing a new robust global surveillance
The Council will now have, as a rule, four weeks to adopt the system based on comparable data, appointing
Commission's proposal. a European Chief Epidemiologist and a governance
EU Commission Staff Working Document “Analisys of the structure, preparing an annual State of Preparedness
recovery and resilience plan of Italy”. Report, setting-up a framework and a toolbox for the
Factsheet of the EU Commission activation of an EU Pandemic State of Emergency;
Statement by President von der Leyen o • adopting the European Health Union, making HERA
operational, establishing a large-scale EU platform for
multi-centre clinical trials.
22 The amendment to the second contract with Moderna was Other actions aim at supporting Member States to
J U N E approved for the activation, on behalf of all EU Member strengthen the overall resilience of health care systems;
2 0 2 1 States, of 150 mln additional doses in 2022. The revised developing Pandemic Preparedness Partnerships and a
COV ID-1 9
contract provides for the possibility to purchase vaccines more coordinated approach to tackling misinformation
adapted to virus variants as well as vaccines for paediatric and disinformation.
use and booster vaccines. The Communication will be presented to the European
Parliament and the Council. The Commission will follow
up with concrete deliverables in the second half of 2021.
21 European Innovation Scoreboard 2021, which shows that
JUNE Europe's innovation performance continues to improve
2021 EU-Canada Summit – the two parties:
across the EU: the EU is performing better than China, Brazil, 14
South Africa, Russia, and India, while South Korea, Canada, J U NE • reconfirmed the common goals on fighting climate
Australia, the United States, and Japan have a performance 2021 change, harnessing the potential of innovation, trade
lead over the EU. On average, the innovation performance and technology;
of the EU has increased by 12.5 percentage points since • launched an EU-Canada dialogue on health, an
2014. Performance has increased the most in Italy, Estonia, Ocean Partnership Forum and an EU-Canada Strategic
Greece, Lithuania and Cyprus. Partnership on Raw Materials;
2021 Regional Innovation Scoreboard: the positive trend • reaffirmed the commitment to the full
applies to innovation across EU regions (Italy card) implementation of EU-Canada Comprehensive
Economic and Trade Agreement (CETA).
18 EU Commission implementing decision on the financing of EU-Canada Summit Joint Statement
COV ID-1 9
JUNE the ‘EU4Health Programme’ and the relevant Work Program
2021 for 2021 (ie. Annex to the Implementing decision), that will
provide €312 mln for crisis preparedness, disease 14 The Regulation of the EU digital COVID certificate was
prevention, health systems and the healthcare workforce, J U NE officially signed in the presence of the Presidents of the
2021 EU Commission, EU Parliament and EU Council. It will
and digitalisation.
apply for 12 months starting from 1 July 2021.
Member States shall refrain from imposing additional
18 The Court of First Instance of Brussels decided to grant COV ID-1 9 travel restrictions on the holders of an EU Digital COVID
JUNE interim measures in the case brought against AstraZeneca Certificate, unless they are necessary and proportionate
2021
COV ID-1 9 by the European Commission and the 27 EU Member States. to safeguard public health.
The Commission committed to mobilising €100 mln under
the Emergency Support Instrument to support Member
NextGenerationEU: €20 bln were raised, in EU Commission States in providing affordable tests.
15
JUNE first NextGenerationEU transaction, via a 10-year bond due
COV ID-1 9
2021 on 4 July 2031.
11 G7 Summit: President von der Leyen outlines key EU
J U NE priorities.
UE-USA Summit: it marked the beginning of a renewed 2021 Statement by President von der Leyen ahead of the G7
15
JUNE transatlantic partnership and set a joint agenda for EU-US Summit.
2021 cooperation in the post-pandemic era.
Three major new trade initiatives:
• creating a Cooperative Framework for Large Civil Aircraft
thus resolving almost 17 years of disputes
• engaging in discussions to resolve differences on
measures regarding steel and aluminium;
• establish an EU-US Trade and Technology Council.
EU USA Joint statementI S
IEuropean (European Commission)
T I T U T I O N A L N E W S
9 Speech by President von der Leyen on the
J U NE conclusions of the special European Council (24-25
2021
COV ID-1 9
May) and on the preparation of the G7 Summit (11-
13 June) and the forthcoming EU-U.S. Summit.
Recalling the new global trade initiative addressed to
the WTO, aiming to deliver more equitable access to
vaccines and therapeutics, she reconfirmed that
“intellectual property has to be protected because it
is the idea behind the breakthrough, and it retains
the incentives for innovation in research and
development.”
8 State aid: Commission approved €800 million Italian
J U NE scheme to support companies affected by the
2021 coronavirus outbreak and provides incentives to
COV ID-1 9
companies for directing their activities to research
and/or production of certain products that are
crucial to address the coronavirus outbreak.
8 EU budget 2022: an annual EU budget of €167.8 bln
J U NE for 2022 was proposed, to be complemented by an
2021
estimated €143.5 bln in grants under
NextGenerationEU. The draft budget for 2022 is part
of the EU's long-term budget as adopted at the end
of 2020, reflects the EU's political priorities, aiming
to ensure a sustainable recovery. The funding will
help rebuild and modernise the EU, by fostering the
green and digital transitions, creating jobs and
strengthening Europe's role worldwide.
Q&A
8 2020 EU Budget: two complementary pieces on EU
J U NE budget performance reporting were presented:
2021
the Annual Management and Performance Report
for the EU budget that shows how the EU budget is
capable of achieving major results, and can play a
critical role in times of crisis.
A forward-looking Communication on the
performance framework for the EU long-term
budget 2021-2027. The performance framework will
make sure that the EU Commission preserves the
strong focus on the achieved results in the future,
starting from the effective implementation of the
current multiannual financial framework,
complemented by the NextGenerationEU recovery
instrument.
This report was closed with information available as of 18.00 on 22 June 2021News from the main national
F O C U S O N and european healthcare
institutions
News
Italian Government - Covid-19 vaccinations in Italy - the numbers
The official information provided on the government’s website (link), regarding Covid-19 vaccinations, shows:
(a) 48.316.875 Doses administered as at 06.01 a.m. on 25 June 2021
(b) 47.722.029 Doses administered as at 06.01 a.m. on 24 June 2021
(a-b) 594.846 Doses administered on 24 June 2021, including first and second jabs and Janssen
single jab
var. % +7,1% Variation as compared to the previous day
As for those who have completed their vaccination cicle (who then received the second jab of one of the vaccines
Pfizer/Biontech, Moderna, Astrazeneca or the single dose of the vaccine Janssen), the situation is:
(a) 16.947.093 Vaccinated persons as at 06.01 a.m. on 25 June 2021
(b) 16.629.336 Vaccinated persons as at 06.01 a.m. on 24 June 2021
(a-b) 317.757 Persons who have completed their vaccination on 24 June 2021
var. % +10,6% Variation as compared to the previous day
AIFA – Italian Medicines Agency
21 June - Monitoring pharmaceutical spending. AIFA published national and regional date for January-March 2021. ((Circular CS21017))
ALSO
18 June - Use of tocilizumab as a therapy for patients suffering from covid-19 AIFA has inserted the medicinal product, tocilizumab, in
COV ID-1 9
the list of medicinal products referred to under law 648/96 for the treatment of adults admitted to hospital with serious COVID-19
infection and/or with indications of high levels of systemic inflammation and a rapidly worsening clinical condition.
ALSO 18 May - COVID-19 monoclonal antibody monitoring: the eleventh report (data referring to 11– 17 May) and the tenth report (data
COV ID-1 9
referring to 4- 10 May) were published.
17 June - AIFA Webinar "informed consent in Covid-19 Covid 19 trials: is the problem the solution ?" held by Prof. Ezekiel J. Emanuel
ALSO regarding the need for informed consent as an essential element of research ethics (Thursday June 24 2021 at 15:30)
COV ID-1 9
15 June - AIFA published the following notice on its site Derogation - procedures - visits -assistance - monitor/ auditor- during- the-
pandemic-Min. decree -15-November-2011 that, given the ongoing nature of the epidemiological conditions, reports on measures to
ALSO
COV ID-1 9
facilitate the completion of training for new monitors/auditors who have already begun training. (Circular TR21006S).
14 June - Resolution on the use of the medicinal products, namely the Comirnaty and Moderna COVID-19 vaccines, for heterologous
ALSO vaccination for subjects under 60 who have received a first dose of Vaxzevria, was published on the Official Gazette No. 141 of 15 June
COV ID-1 9
(AIFA Notice of 14 June and Opinion of the Scientific and Technical Committee of 13 June)
14 June - FNOMCeO AIFA technical round table set up -on medicinal product policies for doctors and dentists
10 June - AIFA's fifth pharmacovigilance report on COVID-19 vaccines published. Collected and analysed data adress reports of
ALSO
COV ID-1 9 suspected adverse reactions recorded by the National Pharmacovigilance Network between 27 December 2020 and 26 May 2021 for
vaccines used in the current vaccine campaign.
9 June - The fourteenth edition of Pangea was held from 18 to 25 May 2021, an international operation aimed at contrasting the
marketing of illegal or counterfeit medicinal products and medical devices sold online.
9 June - 5% Pay-Back procedure commenced and platform opened for 2021 AIFA has requested pharmaceutical companies, as from 2
pm on 9 June 2021, to consult the list of the products for which they can adopt the 5% pay-back procedure and the amounts to be paid
through the link "Pay-back Methods", Section https://servizionline.aifa.gov.it/. (Circular CS21016)News from the main national
and european healthcare
institutions
F O C U S O N
News
EMA – European Medicines Agency
22 June - EMA’s committee for human medicines has approved two additional manufacturing sites for the production of
ANCHE Comirnaty. One site, located in Reinbek, Germany, is operated by Allergopharma GmbH & Co. KG. The other in Stein,
COV ID-1 9
Switzerland, is operated by Novartis Pharma.
18 June - EMA’s Management Board published revised implementing rules to the Fee Regulation – Council Regulation
(EC) No 297/95 – which shall enter into force on 28 January 2022 Fees payable EMA: revised implementing rules fee
regulation
18 June - Questions and answers on labelling flexibilities for COVID-19 vaccines (updated)
ALSO
COV ID-1 9
18 June - Published on EMA’s website the safety update reports of Comirnaty, Vaccine Moderna, Vaccine Janssen,
ALSO
Vaxzevria
COV ID-1 9
17 June - EMA held a press conference to provide an update on its latest activities in the context of the COVID-19
ALSO
COV ID-1 9 pandemic
14 June - EMA has achievementspublished its 2020 annual report that provides an overview of the Agency’s major and
contributions to public health in Europe.
ALSO
COV ID-1 9 11 June - COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality
ALSO
11 June - Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
COVI1 9
11 June - EMA’s CHMP has approved a new manufacturing site for the production of Moderna COVID-19 vaccine finished
ALSO
product. The site, operated by Recipharm, is located in Monts, France.
CO V ID-1 9News from the main national
and european healthcare
institutions
F O C U S O N
News
EMA – European Medicines Agency
11 June - COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis
ALSO
COV ID-1 9
11 June - International regulators and WHO address need to boost COVID-19 vaccine confidence ICMRA and WHO have
jointly developed a statement to help healthcare professionals increase trust and confidence in COVID-19 vaccines and
ALSO
COV ID-1 9
answer questions from patients about the development, regulatory review and safety monitoring of these vaccines.
8 June - EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17
ALSO
COV ID-1 9
7 June - EMA raises awareness of clinical care recommendations to manage suspected thrombosis with
thrombocytopenia syndrome. EMA’s COVID-19 taskforce (COVID-ETF) is advising healthcare professionals in the EU to
ALSO
COV ID-1 9
consider recommendations by learned societies when assessing people with signs and symptoms of thrombosis with
thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria and COVID-19 Vaccine Janssen.
7 June - EMA will host a webinar on 29 july: How sponsor organisations can prepare for CTIS. The webinar, open to all
sponsor organisations, will focus on how sponsor organisations can prepare for CTIS, how Member States aim to support
sponsor preparedness and adoption of CTIS, the role of the Clinical Trial Regulation and how sponsors can best make use
of EMA’s CTIS training materials. Registration is free of charge and the agenda will be published in due course.
MedTech Europe
17 June - MedTech Europe published a position paper on the question of how technologies and data provide benefits for
patients, health professionals and health systems.
The European association of health technology companies stressed that on account of the uncertainty and fragmentation
on the way GDPR is applied in various EU countries, it is very difficult to gain access to the health data to develop new
solutions for the treatment of patients and advance personalized treatments.
The document therefore recommends some areas in which more coherent rules would make better use of health data
while safeguarding privacy, security and data protection, among which can be pointed out:
• implementing common guidelines on the anonymisation and pseudonymisation;
• exceptions in the public interest and for preventive medicine, especially as regards medical research;
• the construction of a health-data transfer system to within and outside the European Economic Area.
This report was closed with information available on 22 June 2021Selection of projects,
campaigns and studies
promoted by
Farmindustria, in
cooperation with the
W O R K I N G O N institutions, associate
companies, patients,
doctors and stakeholders
School-work Alternance
The second cycle of the three-year School-work alternance (PCTO, Path to Transversal Skills and Guidance) project in
the pharmaceutical sector organised by Farmindustria in Lazio and Lombardy to raise interest of high school students
in the pharmaceutical sector and guide them in choosing a university, ended in June. The project is an important
public – private partnership with regional school offices, ANPAL (National Agency for Labor Policies), local
Confindustria associations and trade unions and, as of today, has seen the participation of 35 member companies
which have opened their sites to over 200 students for visits, project work and internships.
On 13 July, from 9:30 to 11:30, an online event will take place, open to all member companies where, together with
the project partners, we’ll listen to the students and their experience in the project. The meeting will end with the
virtual award of a scholarship to the Schools, made available by the Edison Foundation which collaborates with
Farmindustria for initiatives aimed at supporting the dissemination of technical and scientific culture and improving
the integration between educational systems and training.
More details on the event and the registration are available on Circular DG21008.
Plasma product – lifesaving drugs
This year, in Rome, Italy hosted the global event World Blood Donor Day, the World Day dedicated to the
blood donors established by the World Health Organization.
Building on this important initiative and in view of the impact of the pandemic Covid-19 on plasma collection
internationally, Farmindustria organized a webinar entitled "plasma products, lifesaving drugs". The event
represented an opportunity, with the help of all the main stakeholders, to heighten the awareness of the value
of plasma and plasma products and promote discussion on this strategic resource for the country, while at the
same time stressing its critical importance and laying the foundations for measures to enhance our country’s
capacity to supply such drugs so as to ensure patients’ health.Data to keep abreast of
events in the
pharmaceutical sector
I N F O D A T A
539 thousand 3.9 million 10.2 million
The daily average of vaccine doses people with
doses of vaccines delivered complete
administered vaccination
in the week 14-20 April in the week 14-20 April since the campaign's start
7.3% more than the preceding week By producing companies, +15.9% compared equal to 26.2% of the population. In the
As at 20/6 more than 46 million jabs were to the previous week. As at 20/6, since the week 14-20/6 1.7 million persons received
administered (first, second and single doses) campaign's start, the ratio of jabs to doses a vaccination, a daily average of about 243
since the campaign’s start (27/12/2020). delivered in Italy was 92.7%. thousand people.
Source: Farmindustria calculations based on Source: Farmindustria calculations based on Source: Farmindustria calculations based
the Covid-19 Vaccine Data Report the Covid-19 Vaccine Data Report on the Covid-19 Vaccine Data Report
www.governo.it www.governo.it www.governo.it
22% of patients 82% of patients 47%
use apps to Interested in of medical specialists
remember to take a collaborative has carried out
medicine platforms tele-consultations
among the health apps: among doctors during the Covid19 emergency
21% of patients use apps to control clinical The data demonstrate considerable interest while the percentage of General
parameters, 33% makes use of apps to by patients for the use of collaborative Practitioners (GP) was 39%. The data are
monitor their lifestyle. The use of health platforms especially after the Covid19 growing: before the pandemic 21% of
apps is still not widespread , but thanks to pandemic - before it only 11% of patients medical specialists has carried out tele-
them, 46% of patients who use them feel used one. Instant messaging and email apps consultations, 12% among GPs. There is
more aware of their pathologies and are among the communications channels great interest in the future use of tele-
health in general, while 42 percent claim registereing the highest level of interest for consultation: 81% of hospital specialists are
to have found a support for their own future use. interested and 86% of GPs. Tele-visiting and
health plans. tele-monitoring are other telemedicine
Source: Politecnico di Milano, Digital instruments whose use has grown during
Source: Politecnico di Milano, Digital healthcare innovation observatory , 2021 the pandemic and for which there is
healthcare innovation observatory , 2021 widespread interest for their future use.
Source: Politecnico di Milano, Digital
healthcare innovation observatory , 2021News from the main national
and european healthcare
institutions
E F P I A / I F P M A
EFPIA
EFPIA Board - Composition of the EFPIA Board 2021-2023
EFPIA Statutory General Assembly – the new Presidency Team commitment
EFPIA Heads of Associations Committee, among the topics in the agenda: Country Engagement project updates (High Level Forum
and access issues, Intellectual Property, incentives and Orphan and Paediatrics Regulations); IP waiver for COVID-19 product and
the debate underway at the WTO; European Health Emergency Preparedness and Response Authority (HERA), update about
status and next steps.
EFPIA response to EPSCO discussion on access to medicines and medical devices for a stronger and resilient EU.
EFPIA- IFPMA joint statement Biopharmaceutical CEO Brussels meeting with EU leaders
The Strategic Research and Innovation Agenda agreed by EFPIA, COCIR, MedTech Europe, EuropaBio and Vaccines Europe in
collaboration with the EU Commission
Joint statement
The pharmaceutical industry in figures 2021
“International EU27 pharmaceutical production, trade, dependencies and vulnerabilities” by the European Centre for
International Political Economy (ECIPE): it provides evidence on EU27 production, imports, and exports of pharmaceutical
products, and on how imports and exports have developed over time. It highlights the EU dependencies and the EU exports
vulnerability if all countries in the world would reduce their import dependencies.
IFPMA
G7 Summit (agenda):
• Communiqué “Our Shared Agenda for Global Action to Build Back Better”, that reconfirms the Leaders’ commitment to: end the
pandemic and prepare for the future; reinvigorate the economies and continue to support them for as long as is necessary, secure
future prosperity by championing freer, fairer trade; protect the planet by supporting a green revolution; strengthen the partnerships;
embrace the fundamental values such as democracy, freedom, equality, the rule of law and respect for human rights.
• “G7 Carbis Bay Health Declaration”, that reconfirms: the willingness to work expeditiously and collectively toward the goal of ending
the COVID-19 pandemic; the need for global solutions in the light of the progresses achieved so far; roles and responsibilities to
strengthen the global health and health security architecture, to build a resilient, integrated and inclusive global health system
prepared and equipped to prevent the causes and escalation of disease, to detect emerging health threats quickly and to take action
across each stage of the prevent, detect, respond and recover cycle.
• “100 Days Mission to respond to future pandemic threats - A report to the G7 by the pandemic preparedness partnership”, drafted
by a group of International experts and discussed in the context of the G7 Health Ministerial meeting: the Governments and industry
leaders agreed to work towards a plan to develop and deploy high-quality diagnostics, therapeutics and vaccines in just 100 days after
a new pandemic threat is identified. It makes recommendations for Governments, industry, international organizations and other
stakeholders to accelerate the response to a future pandemic.
IFPMA Statement on the G7 agreement to work in partnership with the private sector towards a “100 Days Mission”
Press Release: Biopharmaceutical industry welcomes COVID-19 vaccine-sharing pledges but warn challenges remain to urgently address
vaccine inequity.
G7 Finance Ministerial meeting, Communiqué contains language acknowledging the severity of the AMR threat and a commitment to
work together with industry to tackle the issue, especially in light of the lessons learnt from COVID-19.
IFPMA and ABPI Joint Statement Global pharmaceutical industry response to G7 Comminiqué on AMRNews from the
Confindustria Network
C O N F I N D U S T R I A
News
22 A meeting of the Internationalization Technical Group of Confindustria was held to examine questions connected
JUNE to: commercial policy; the promotional activities of the ICE Agency (Italian Trade Agency); the refinancing of the
2021
Simest 394 Fund; the activities of B20.
17 This year too Confindustria will participate in the Open Innovation and Corporate Venture Capital Observatory
J U NE (CVC), promoted by Assolombarda and InnovUp, the main association of the Italian innovation ecosystem created
2021
from the merger of Italia Startup and Apsti. The Observatory aims at extending Open Innovation in all its
expressions, from cooperative relations between firms, universities and research institutes, technology exchange, to
ideas and skills between companies, and partnerships with start-ups and investing in their capital.
Confindustria was heard in a joint hearing by the Constitutional Affairs and Environment Committees of the
17 Chamber of Deputies on the Decree Law PNRR Governance and initial simplifications, during which the need for
J U NE
2021 the involvement of institutions and intermediary bodies was highlighted in order to implement the measures
envisaged, together with an " unprecedented learning exercise", in terms of organization, the measurement of
objectives and respect for scheduled timelines.The following is the link to the document filed.
9 A meeting of the General Council was held which, inter alia, approved certain amendments to its Regulation for the
J U NE
2021 Confindustria System, drawn up by the Organisational Coordinating Committee designed to simplify and streamline
some association mechanisms.
9
JUN
2021News from companies
associated with
Farmindustria
P H A R M A C E U T I C A L
C O M P A N I E S
N E W S
News
MA Y - J U L UCB – New call for Community Health Fund
2021
UCB announced the release of a new call for its Community Health Fund through which it will support projects that
can promote the mental health of young people aged 15-24. Psychological distress related to COVID-19 is widespread
because of the fear of the virus, isolation, social distancing and economic insecurity. Teenagers and young people
especially are among the hardest hit subjects. The fund will accept applications until the deadline of July 15, 2021.
Associations and charities active in this area will be able to apply by submitting their projects through this link.
22 Jannsen Italy-Censis project “I Cantieri per la sanità del futuro”
J U NE
2021 Jannsen Italy collaborated on the project “I Cantieri per la sanità del futuro”, promoted by Censis to jointly elaborate
proposals for a Health System that is more efficient and more effective to address tomorrow’s needs, starting with the
feedback from regional health services. On 22 June, a study was presented analyzing the overall landscape of the
National Health Service, with regional focuses. Together with Massimo Scaccabarozzi, the event saw the participation
of Roberto Speranza, Minister of Health, Enrico Coscioni, President of the National Agency for Regional Health
Services (AGENAS), Massimiliano Valerii, Director General of Censis, Manuela Lanzarin, Veneto Health Regional
Minister, Alessio D’Amato, Lazio Health Regional Minister and Pier Luigi Lopalco, Puglia Health Regional Minister.
Recording of the event at the following link.
Info: infoagenda@farmindustria.itYou can also read
