Patenttistrategiat lääkealalla määräävän markkina-aseman väärinkäyttönä

Lääkealalla käytetään erinäisiä patenttistrategioita, joiden avulla lääkeyhtiöt kykenevät pidentämään yksinoikeuttaan markkinoilla ja siten maksimoimaan lääkevalmisteestaan saatavat tuotot. Tällaisina patenttistrategioina toimivat erityisesti patenttisuojaa keinotekoisesti pidentävät toissijaiset patentoinnit, jotka ovat nykyisen eurooppalaisen patenttijärjestelmän kannalta täysin sallittuja, mutta tutkielmassa esitettävin tavoin kilpailuoikeuden ja erityisesti määräävän markkina-aseman väärinkäytön kiellon kannalta mahdollisesti ongelmallisia. Pidentämällä patenttisuojaansa strategisesti lääkeyhtiöt saavat takaisin lääkkeen tutkimukseen ja kehitykseen investoimiaan varoja, mutta aiheuttavat samalla esteitä kilpailijoiden markkinoille pääsylle. Erityisesti silloin, kun lääkkeen alkuperäisvalmistaja pidentää yksinoikeuttaan keinotekoisesti patenttistrategioidensa avulla, se rajoittaa markkinoita siten, että lääkkeen rinnakkaisvalmistajien pääsy markkinoille estyy tai viivästyy. Tästä seuraa väistämättä ongelmia kilpailijoiden lisäksi myös sekä kuluttajille että koko yhteiskunnalle lääkkeiden korkeamman hinnoittelun ja kasvavien terveydenhuoltokustannusten myötä. Lisäksi patenttistrategioilla saattaa olla yhteys vähentyneeseen lääkekehitykseen ja uusien lääkeinnovaatioiden määrään. Tutkielmassa kuvataan erityisesti alkuperäisvalmistajien hyödyntämiä patenttistrategioita ja niiden taustalla vaikuttavia lääkealan erityispiirteitä sekä vastataan lainopin keinoin tutkimuskysymykseen siitä, voidaanko lääkealalla hyödynnettävät patenttistrategiat tulkita määräävän markkina-aseman väärinkäytöksi. Lääkeyhtiöiden patenttistrategioita tulkitaan kilpailuoikeuden valossa erityisesti niiden markkinoita rajoittavan luonteen vuoksi. Lisäksi tutkielmassa nostetaan esiin patenttistrategioista aiheutuvia muita yhteiskunnallisia seurauksia mahdollisina osoituksina määräävän markkina-aseman väärinkäytöstä. Johtopäätöksenä tutkielmassa todetaan, että lääkealalla hyödynnettävät patenttistrategiat voidaan nykyisen oikeuskäytännön valossa tietyissä tilanteissa tulkita määräävän markkina-aseman väärinkäytöksi erityisesti niiden kilpailua rajoittavan luonteen vuoksi. Tutkielmassa myös korostetaan kilpailuoikeudellisen puuttumisen tärkeyttä patenttistrategioihin nykyisen patenttioikeuden salliessa nämä patenttijärjestelmää hyväksikäyttävät, mutta markkinoita ja kehitystä rajoittavat lääkealalla vallitsevat patenttistrategiat. Tutkielman keskeisimpinä lähteinä on käytetty Euroopan unionin voimassa olevaa oikeutta ja ratkaisukäytäntöä sekä pääosin kansainvälistä oikeuskirjallisuutta

Spiritual well-being correlates with quality of life of both cancer and non-cancer patients in palliative care - further validation of EORTC QLQ-SWB32 in Finnish

Publisher Copyright: © 2023. The Author(s).BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) has developed the Spiritual Well-being Questionnaire (EORTC QLQ-SWB32), a measure of spiritual well-being validated with people receiving palliative care for cancer, although its usefulness is not restricted to that population. We aimed to translate and validate this tool in Finnish and to study the relationship between spiritual well-being (SWB) and quality of life (QOL). METHODS: A Finnish translation was produced according to the guidelines of EORTC and included forward- and back-translations. Face, content, construct and convergence/divergence validity and reliability were studied in a prospective manner. QOL was assessed with EORTC QLQ-C30 and 15D questionnaires. Sixteen individuals participated in the pilot testing. 101 cancer patients drawn from oncology units, and 89 patients with other chronic diseases drawn from religious communities in different parts of the country participated in the validation stage. Retest was obtained from 16 individuals (8 cancer and 8 non-cancer patients). Inclusion criteria included patients with either a well-defined palliative care plan, or who would benefit from palliative care, as well as the capacity to understand and communicate in Finnish. RESULTS: The translation appeared understandable and acceptable. Factorial analysis identified four scoring scales with high Cronbach alfa values: Relationship with Self (0.73), Relationship with Others (0.84), Relationship with Something Greater (0.82), Existential (0.81), and, additionally, a scale on Relationship with God (0.85). There was a significant correlation between SWB and QOL in all participants. CONCLUSIONS: The Finnish translation of EORTC QLQ-SWB32 is a valid and reliable measure both for research and clinical practice. SWB is correlated with QOL in cancer and non-cancer patients undergoing palliative care or who are eligible for it.Peer reviewe

Delayed Development of Aneurysmal Dilatations in Patients with Extracranial Carotid Artery Dissections

Peer reviewe

Characteristics of specialists treating hypothyroid patients:the “THESIS” collaborative

Introduction: Thyroid specialists influence how hypothyroid patients are treated, including patients managed in primary care. Given that physician characteristics influence patient care, this study aimed to explore thyroid specialist profiles and associations with geo-economic factors. Methods: Thyroid specialists from 28 countries were invited to respond to a questionnaire, Treatment of Hypothyroidism in Europe by Specialists: an International Survey (THESIS). Geographic regions were defined according to the United Nations Statistics Division. The national economic status was estimated using World Bank data on the gross national income per capita (GNI per capita). Results: 5,695 valid responses were received (response rate 33·0%). The mean age was 49 years, and 65·0% were female. The proportion of female respondents was lowest in Northern (45·6%) and highest in Eastern Europe (77·2%) (p &lt;0·001). Respondent work volume, university affiliation and private practice differed significantly between countries (p&lt;0·001). Age and GNI per capita were correlated inversely with the proportion of female respondents (p&lt;0·01). GNI per capita was inversely related to the proportion of respondents working exclusively in private practice (p&lt;0·011) and the proportion of respondents who treated &gt;100 patients annually (p&lt;0·01). Discussion: THESIS has demonstrated differences in characteristics of thyroid specialists at national and regional levels, strongly associated with GNI per capita. Hypothyroid patients in middle-income countries are more likely to encounter female thyroid specialists working in private practice, with a high workload, compared to high-income countries. Whether these differences influence the quality of care and patient satisfaction is unknown, but merits further study.</p

Common variation in PHACTR1 is associated with susceptibility to cervical artery dissection

Cervical artery dissection (CeAD), a mural hematoma in a carotid or vertebral artery, is a major cause of ischemic stroke in young adults although relatively uncommon in the general population (incidence of 2.6/100,000 per year). Minor cervical traumas, infection, migraine and hypertension are putative risk factors, and inverse associations with obesity and hypercholesterolemia are described. No confirmed genetic susceptibility factors have been identified using candidate gene approaches. We performed genome-wide association studies (GWAS) in 1,393 CeAD cases and 14,416 controls. The rs9349379[G] allele (PHACTR1) was associated with lower CeAD risk (odds ratio (OR) = 0.75, 95% confidence interval (CI) = 0.69-0.82; P = 4.46 × 10(-10)), with confirmation in independent follow-up samples (659 CeAD cases and 2,648 controls; P = 3.91 × 10(-3); combined P = 1.00 × 10(-11)). The rs9349379[G] allele was previously shown to be associated with lower risk of migraine and increased risk of myocardial infarction. Deciphering the mechanisms underlying this pleiotropy might provide important information on the biological underpinnings of these disabling conditions

Patients with allergic rhinitis and allergic asthma share the same pattern of eosinophil and neutrophil degranulation after allergen challenge

<p>Abstract</p> <p>Background</p> <p>Patients with allergic rhinitis and allergic asthma demonstrate comparable local and systemic eosinophil inflammation, and yet they present with different clinical pictures. Less is even known about the contribution of neutrophil inflammation in allergic diseases. The aim of the study was to examine the propensity and selectivity of granule release from primed systemic eosinophils and neutrophils in allergic rhinitis and allergic asthma after seasonal and experimental allergen exposure. We hypothesize that the dissimilar clinical manifestations are due to diverse eosinophil and neutrophil degranulation.</p> <p>Methods</p> <p>Nine birch pollen allergic patients with rhinitis, eight with asthma and four controls were studied during pollen season and after nasal and bronchial allergen challenge. Eosinophils and neutrophils were incubated in vitro with assay buffer and opsonized Sephadex particles for spontaneous and C3b-induced granule protein release. The released amount of eosinophil cationic protein (ECP), eosinophil peroxidase (EPO) and myeloperoxidase (MPO) was measured by specific radioimmunoassay.</p> <p>Results</p> <p>C3b-induced degranulation resulted in increased release of ECP and MPO from primed blood eosinophils and neutrophils in both allergic rhinitis and allergic asthma during pollen season and after both nasal and bronchial challenge (p-values 0.008 to 0.043). After bronchial challenge, the ECP release was significantly higher in the rhinitic group compared to the asthmatic group [19.8 vs. 13.2%, (p = 0.010)]. The propensity for EPO release was weak in all challenge models but followed the same pattern in both allergic groups.</p> <p>Conclusions</p> <p>Systemically activated eosinophils and neutrophils have similar patterns of degranulation after allergen exposure in allergic rhinitis and allergic asthma. The released amount of ECP, EPO and MPO was similar in all allergen challenge models in both allergic groups. Our results indicate that other mechanisms than the magnitude of eosinophil and neutrophil inflammation or the degranulation pattern of the inflammatory cells determines whether or not an allergic patient develops asthma.</p