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Lääketeollisuus ry

Lääketeollisuus ry on Suomessa toimivan innovatiivisen lääketeollisuuden edunvalvontajärjestö.

Lobbying Activity

Meeting with Sebastian Tynkkynen (Member of the European Parliament)

27 Nov 2025 · Lääketeollisuus ja innovaatio

Meeting with Anniina Iskanius (Cabinet of Executive Vice-President Henna Virkkunen)

1 Apr 2025 · Preparedness and role of medicines

Meeting with Sebastian Tynkkynen (Member of the European Parliament)

1 Oct 2024 · EU:n terveysalan strategia, kehittäminen ja kasvu

Meeting with Alviina Alametsä (Member of the European Parliament)

25 Jun 2024 · Exchange of views

Meeting with Annukka Ojala (Cabinet of Commissioner Stella Kyriakides)

20 Jun 2024 · Pharma Reform

Response to Health technology assessment - Joint clinical assessments of medicinal products

29 Mar 2024

Pharma Industry Finland response to JCA Implementing Act public consultation THE SUCCESS OF THE EU HTAR RELIES ON THE ABILITY OF THE SYSTEM TO DELIVER HIGH-QUALITY JCA REPORTS Pharma Industry Finland (PIF) represents the innovative pharmaceutical industry in Finland. Our 40 member companies have extensive experience in submitting HTA and pricing and reimbursement dossiers to support the national decision making. The EU HTA Regulation will affect the long-established national processes in less than 10 months time and still there are multiple concerns about the implementation. We support the aims for improving patient access to medicines and harmonization of transparent HTA criteria, as well as reducing duplicate work. The JCA implementing act (IA) is crucial for successful implementation of the HTAR, as it sets out the framework and procedural requirements. Thus the JCA IA should enable and support the industry in delivering high-quality dossier submissions which are necessary for high-quality JCA reports. We see that the draft JCA IA will probably result in dossier submissions that will not meet the member states requirements. PIF has several concerns about the current draft JCA IA. The main concern is the lack of involvement of the Health Technology Developer (HTD) throughout the JCA process and especially in the scoping. LACK OF INVOLVEMENT OF THE HTD Over the years, the Finnish HTA system has developed towards more meaningful dialogue between the HTD and the HTA organizations. This is an advantage to all those involved, as it makes it possible to clarify any unclear issues as early on as possible. We strongly recommend including the involvement of HTD throughout the process and we agree with EFPIAs proposals that: - The HTD should have the opportunity to leverage all relevant information, evidence, and knowledge as a key input into the definition of the assessment scope. Furthermore, - The HTD should have an opportunity to meet and discuss with the assessor/co-assessor its views on the draft assessment scope. This should not be subject to consideration of relevance as it might result in unequal treatment of the HTDs. UNBALANCED TIME ALLOCATION The current draft JCA implementing act has unbalanced time allocation between the scoping and submission stages. Also the time allocated to the member states to respond to the PICO survey is very limited, which affects especially the smaller countries with limited HTA resources. Early dialogue and a scoping meeting involving all relevant stakeholders would make the scoping process more efficient. It could bring together the patients, clinical experts and the HTD to clarify all relevant viewpoints at an early stage. At the time of marketing authorization submission to the European Medicines Agency, the HTD has invested years on research and has extensive knowledge and data about the product and of the clinical context, and this should be acknowledged in the process. LACK OF TRANSPARENCY The draft JCA IA limits visibility to the HTD on draft assessment scope proposed to the member states. We are concerned that in many cases there will be a need for additional analyses and documentation with limited time to respond to. Limited transparency and predictability together with the expected complexity or number of PICOs may affect the national HTA process and result in unnecessary delays in patient access contrary to the aim of the regulation. - The HTD should have visibility on the draft assessment scope proposed by the assessor/co-assessor as well as on the PICO survey responses from Member States (in an anonymized manner) at the earliest possible stage, to be able appropriate time to submit a high-quality submission response. PIF is also a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA). In addition to all above, we wish to refer to the EFPIA submission to the public consultation of JCA IA, especially the more detailed annex.
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Meeting with Henna Virkkunen (Member of the European Parliament, Rapporteur for opinion)

20 Feb 2024 · Medicinal products for human use

Meeting with Henna Virkkunen (Member of the European Parliament, Rapporteur for opinion) and Bayer AG

13 Oct 2023 · Medicinal products for human use

Meeting with Nils Torvalds (Member of the European Parliament)

13 Dec 2022 · Medicine regulation

Meeting with Henna Virkkunen (Member of the European Parliament)

13 Dec 2022 · EU Health Policy

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

12 Dec 2022 · Upcoming EU's pharmaceutical legislation

Meeting with Jutta Urpilainen (Commissioner)

26 Sept 2022 · Health policy; pandemic response in partner countries.

Meeting with Mauri Pekkarinen (Member of the European Parliament)

26 Aug 2022 · Discussion on the meaning of EU innovation for the medical industry

Response to A European Health Data Space

15 Jul 2022

See attached file for Pharma Industry Finland's comments.
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Response to Labelling requirements for unauthorised medicinal products used in Clinical Trials

28 Jun 2022

This is a welcome change that ensures the smooth conduct of clinical trials, especially early-phase ones, and assures the continuous medication of trial patients.
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Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

The EU should be ambitious and strive for being the world leader in medical innovation as this benefits European patients and people. Global competition for life science investments is heavy. Europe should invest in the fact that Europe is an attractive and competitive operating environment for pharmaceutical research and development. The EU regulatory framework should foster research, innovation, and competitiveness. Consistency between pharmaceutical, chemical, and environmental legislative frameworks, incentives, financial infrastructure and investment in education and skills are needed to ensure the EU is a competitive location for research, innovation, and advanced manufacturing. On a national level it is important to foster high-tech manufacturing and attract investment. The regulatory framework should encourage the use of novel clinical trial designs and also ensure ongoing scientific dialogue throughout product development. On the EU level, it will be crucial to use the full potential of data and digitalisation to support the health and well-being of Europeans. Developments in medicine, pharmaceuticals, devices, data, and digitalisation will lead to more personalised healthcare solutions to benefit the patient and enable more patient-centric solutions. Data and its ethical use are a European strength. For the European patients to benefit from digitalisation PIF proposes that the EU should replace the paper patient information leaflets with electronic information. To utilise the potential of data the EU should enable the future innovative approaches to medicines R&D e.g. by ensuring the acceptance of RWE in medicines evaluation pre and post-authorisation. Revision of the Variations Regulation would be an opportunity to simplify and modernise the EU post-approval framework. European incentives framework enables invention. Much of the current research that delivers new innovations is built on products, expertise and research capacity that have evolved over the years and have involved significant risk funding. A stable and predictable incentives framework encourages continued investment and development. The pharmaceutical industry is committed to the work in collaboration with the research field and healthcare to meet the unmet medical needs. The pharmaceutical industry uses of the latest scientific information and employs world's leading professionals to discover new treatments. In order to meet the needs of patients living with a disease where no treatment option exists, the IP framework must encourage finding new treatments and cures. Where the current framework has not yet covered all needs (e.g. OMP and Paediatrics), novel incentives adapted to the specific challenges of particular disease areas should be considered. To ensure patient’s access to medicines well prepared healthcare systems and dialogue in the pharmaceutical supply chain are crucial. On the national level, identifying and removing barriers of access is important. Since market access is dependent on mostly national factors as well as market dynamics, linking incentives to access could jeopardise the objectives of incentivising and improving access to innovation in the EU. On the EU level, dialogue between the health industry sector, the Commission and EU Member States is needed. Learnings of the COVID-19 pandemic must be implemented by maintaining the flexibilities discovered and continuing the dialogues between stakeholders.
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Response to Revision of the EU legislation on medicines for children and rare diseases

22 Dec 2020

The Pharma Industry Finland (PIF) welcomes the Commission efforts to deliver more health and wellbeing to people. PIF members are committed to ensuring that unmet medical needs are addressed and that available treatments reach patients. Children and rare disease patients have benefitted from the medical progress enabled by the orphan medicinal and paediatric regulations. Possible actions taken in the revision of the regulations should keep and improve Europe’s strong basis for innovation to which the pharmaceutical industry and public-private partnerships contribute greatly. Reducing incentives and rewards or linking them with obligations to launch in a specific number of markets will not solve the access issues. The questions on access are best solved separately by working together in a constructive way finding solutions to problems. We have a good example of this in Finland. We have established an annual Pharmaceutical Branch Availability Forum to discuss shortages of medicines and find solutions on availability. The actors of the pharmaceutical sector have worked closely together to find solutions that benefit the patients. Availability of medicines is important issue in the small Finnish markets. At the European level, the EU Health Coalition calls for a Multi-stakeholder Forum for Better Access to Health Innovation. In addition to that, any process to identify unmet medical needs would be best built on a multi-stakeholder discussion that would include patients and their caregivers. If the scope of the incentives is reduced only to ultra-rare diseases with no therapies, it would not redirect investments accordingly but, in the worst case, risk Europe’s attractiveness as a region for innovation. New innovations benefit European patients. Furthermore, it is important to acknowledge the importance of follow-on innovations for patients and their treatment. The Orphan Regulation has incentivised the pharmaceutical industry to deliver treatments for over 6 million patients and up to 107 orphan conditions. The Commission Staff Working Document claims that 14% of orphan medicinal products have annual turnover of over 100 million euros in the EEA. The fact does not support the concept of overcompensation. At the European level, the Commission is responsible for competition in all sectors. Therefore, biosimilar and generic competition after the patent expiry is endorsed. However, in many cases the number of patients with the approved orphan medical products and paediatric indications is limited and they are not attractive to generic and biosimilar developers. The Commission should work with all stakeholders and urgently identify the root causes of access differences to find targeted solutions. Root causes are multifactorial. They cannot be reduced to company decisions only. In order to solve the current challenges, we would need a close collaboration of Member states on pan-European evidence generation, meaningful joint clinical HTA assessment, and novel pricing and payment models. The Commission should also consider all options of the Inception Impact Assessment, including those identified as the ‘baseline’. The Commission Staff Working Document is based on data up to 2017, does not include development after that.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

2 Jul 2020

Lääketeollisuus ry:n lausunto EU:n lääkestrategian tiekarttaan 1.7.2020 Tavoitteet: EU:n lääkestrategia antaa Euroopalle mahdollisuuden vastata tulevaisuuden haasteisiin. Strategia on mahdollisuus 1) löytää ratkaisuja Eurooppaa koetteleviin haasteisiin, kuten ikääntyminen ja kestävyysvaje sekä 2) mahdollisuus pyrkiä yhä parempaan terveyteen ja uuden kasvun luomiseen. Lääketeollisuus ry katsoo, että strategian tavoitteena tulee olla se, että Eurooppa on selkeä johtaja lääketieteellisissä innovaatioissa. Strategiassa on linjattava keinoja tämän toteuttamiseksi. Lääketeollisuus ry toivoo, että strategian avulla voidaan edistää eurooppalaista lääketieteellistä osaamista, lääketieteellisen tutkimuksen eurooppalaista ekosysteemiä sekä varautua ja vastata erilaisiin terveysongelmiin ja myös lisätä alan investointeja ja korkean jalostusasteen teollisuuden työpaikkoja Euroopassa. Keinot: Jotta potilaille voitaisiin saada uusia terveysratkaisuja, Eurooppa tarvitsee tutkimus- ja tuotantoinfrastruktuurin, joka tuottaa seuraavan sukupolven rokotteita ja lääkehoitoja. Tutkimusekosysteemiin tarvitaan lisää palasia: kliinisen tutkimuksen verkostoja, biopankkeja ja datapankkeja. Lisäksi tarvitaan eurooppalaista terveysdataa sekä julkisen ja yksityisen yhteistyömekanismeja. Sääntely-ympäristön tulisi paremmin huomioida innovaatiot, erityisesti myyntilupaprosessissa. Sääntely-ympäristöä voidaan parantaa ottamalla käyttöön arkielämän vaikuttavuus ja näyttö (real world data RWD ja real world evidence RWE), mahdollistamalla innovatiiviset kliiniset tutkimukset ja luomalla lääkkeille nykyistä dynaamisempi regulatorinen prosessi. Euroopan on myös oltava kilpailukykyinen immateriaalioikeuksien suhteen. Lisäksi tulisi edistää innovatiivisia hankintoja, joka veisivät kehitystä kohden vaikuttavuusperusteista terveydenhuoltoa (value-based healthcare). Suomalaiset keinot: Digitalisaatioon, datan hyödyntämiseen ja teollisuuden kilpailukykyyn liittyvät teemat ovat merkityksellisiä Euroopan tulevaisuuden kannalta. Suomi on monelta osin digitalisaation ja datatalouden edelläkävijänä ja se toimii hyvin eurooppalaisena esimerkkinä. Suomalainen terveysalan kasvustrategia (heath sector growth strategy) on hieno esimerkki eri politiikka-alojen välisestä yhteistyöstä, jolla edistetään terveysinnovaatioita. Tätä mallia tulee hyödyntää myös eurooppalaisessa päätöksenteossa. Saatavuus: Häiriöt lääkkeiden saatavuudessa ovat globaalisti kasvava ilmiö, joka näkyy myös Suomessa. Parempi saatavuus on alan toimijoiden yhteinen tavoite. Lisäksi on turvattava uusien innovaatioiden käyttöönotto. Lääketeollisuus ry piti Suomen EU-puheenjohtajakauden aikana esillä eurooppalaisten terveysalan järjestöjen tavoitetta eri lääkealan toimijoiden ja päättäjien korkean tason foorumista, jossa voitaisiin käsitellä terveysinnovaatioiden parempaa saatavuutta ja saavutettavuutta. Lääketeollisuus ry pitää edelleen tärkeänä, että alan toimijat työskentelisivät yhdessä saatavuushäiriöiden minimoimiseksi ja Suomessa pitänyt yllä alan keskinäistä keskustelua. Suomi kohtaa pienen maan markkinan haasteet. Jos lainsäädännöllisiä muutoksia tehdään, niitä aina tarkasteltava ensin suhteessa lääkkeiden saatavuuteen. Suomessa näin toimitaan lääkehuoltoon tehtävissä lainsäädäntötoimissa, samaa suosittelisimme EU-tasolle. Yhteenvetona: Lääketeollisuus toivoo näkevänsä tulevassa EU:n lääkestrategiassa keinot, jolla tiekartan tahtotila ”teollisuuden kilpailukyvyn turvaamisesta” saavutetaan. Lääketeollisuus on sitoutunut työhön tavoitteiden edistämiseksi yhteistyössä lääkealan muiden toimijoiden kanssa. Lääketeollisuus pitää strategian tavoitteita tärkeinä ja on sitoutunut tuottamaan lääketieteellisiä innovaatioita ja saamaan ne potilaiden käyttöön.
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Meeting with Marika Lautso-Mousnier (Cabinet of Vice-President Jyrki Katainen)

15 Oct 2019 · Smart health

Meeting with Marika Lautso-Mousnier (Cabinet of Vice-President Jyrki Katainen)

20 Mar 2019 · Health as engine for growth; health policies, data driven health care, industrial strategy

Meeting with Timo Pesonen (Acting Director-General Internal Market, Industry, Entrepreneurship and SMEs)

19 Mar 2019 · Exchange of views regarding future EU policies on smart health and wellbeing.

Meeting with Jyrki Katainen (Vice-President)

5 Oct 2018 · European research ecosystem and research of pharmaceuticals in the EU

Meeting with Kaius Kristian Hedberg (Cabinet of Commissioner Elżbieta Bieńkowska)

14 Mar 2018 · EU-IP-incentive review and SPC

Meeting with Timo Pesonen (Director-General Communication)

7 Mar 2018 · Discussions of European economy and on future of Europe