Ethical Overview of Pharmaceutical Industry Policies in Turkey from Various Perspectives

Oral, Murat; Özçelikay, Gülbin

doi:10.4274/tjps.88598

Cited by 5 publications

(2 citation statements)

References 6 publications

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“…The same regulation also states that it can issue licenses if it cannot provide absolute evidence for su cient effectiveness and safety in rarely indicated indications for an orphan drug application. 24 A protocol has been signed between the Turkish Ministry of Health and the Turkish Pharmacists' Association (TEB) to supply drugs from abroad that are otherwise unavailable in Turkey, whether licensed or unlicensed. According to this protocol, the provision for the supply of units from abroad was created by the TEB, which serves as an economic operator.…”

Section: Rare Diseases and Orphan Drugs In Turkeymentioning

confidence: 99%

Analysis of Patient Access to Orphan Drugs in Turkey

Kockaya¹,

Atalay

Oğuzhan

et al. 2020

Preprint

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Background: Rare diseases are life-threatening, serious, and chronic genetic conditions that require complex care and have a low prevalence. An estimated one in 15 people worldwide are affected by rare diseases. This study aims to analyze the accessibility, reimbursement status, licensed status, and Anatomical Therapeutic Chemical (ATC) codes of drugs that the European Medicines Agency (EMA) in Turkey considers to be “orphan” pharmaceuticals. Methods: The drugs included in this analysis were obtained from the list of orphan drugs published by the EMA. Orphan drugs’ accessibility and licensing status in Turkey were obtained from the Health Implementation Communiqué published by the Social Security Institution (SGK) and the List of Abroad Active Substance and List of Licensed Products published by the Turkey Pharmaceuticals and Medical Devices Agency (TİTCK). Descriptive analysis was applied to determine the accessibility status of orphan drugs identified by the EMA in Turkey.Results: Based on the EMA, 105 pharmaceuticals were approved with “orphan drug” status by January 2020. Of the 105 rare drugs on the EMA list, 34 were inaccessible in Turkey. Of the 71 available drugs, 23 (32%) were licensed and 48 (68%) were unlicensed in Turkey. Seventeen licensed products (74%) and 17 unlicensed products (35%) were covered by reimbursement. When orphan drugs’ ATC codes were examined, the most common ATC group was found to be “L –Antineoplastic and Immunomodulatory” agents.Conclusion: An orphan drug incentive policy is very important to ensure early access to the drugs used to treat rare diseases. It is obvious that such a policy must prepare for the regulation of orphan drugs in Turkey.

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Section: Rare Diseases and Orphan Drugs In Turkeymentioning

confidence: 99%

Analysis of Patient Access to Orphan Drugs in Turkey

Kockaya¹,

Atalay

Oğuzhan

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

“…In Turkey, in accordance with the Regulation on Medicinal Products for Human Use Permit , the Ministry of Health completes a preliminary examination within 210 days of the date an application is submitted. If the drug complies with legal regulations, its application is finalized [16] .…”

Section: Introductionmentioning

confidence: 99%

Analysis of patient access to orphan drugs in Turkey

Kockaya

Atalay²,

Oğuzhan

et al. 2021

Orphanet J Rare Dis

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Background Rare diseases are life-threatening, serious, and chronic conditions that require complex care and have a low prevalence. An estimated one in 15 people worldwide are affected by rare diseases. This study aims to analyze the accessibility, reimbursement status, licensed status, and Anatomical Therapeutic Chemical (ATC) codes of drugs that the European Medicines Agency (EMA) in Turkey considers to be “orphan” pharmaceuticals. Methods The drugs included in this analysis were obtained from the list of orphan drugs published by the EMA. Orphan drugs’ accessibility and licensing status in Turkey were obtained from the Health Implementation Communiqué published by the Social Security Institution (SGK) and the List of Abroad Active Substance and List of Licensed Products published by the Turkey Pharmaceuticals and Medical Devices Agency (TİTCK). Descriptive analysis was applied to determine the accessibility status of orphan drugs identified by the EMA in Turkey. Results Based on the EMA, 105 pharmaceuticals were approved with “orphan drug” status except for drugs that have lost orphan drug status, decommissioned in the European Union and withdrawn from the European Community Register by January 2020. Of the 105 rare drugs on the EMA list, 34 were inaccessible in Turkey. Of the 71 available drugs, 23 (32%) were licensed and 48 (68%) were unlicensed in Turkey. 17 (74%) of licensed products and 17 (35%) of unlicensed products were covered by reimbursement. When orphan drugs’ ATC codes were examined, the most common ATC group was found to be “L—Antineoplastic and Immunomodulatory” agents. Conclusion An orphan drug incentive policy is very important to ensure early access to the drugs used to treat rare diseases. Considering the capacity and prices for orphan drugs in Turkey, it can be said that many patients with rare diseases have difficulty in their treatment. It is obvious that such a policy must prepare for the regulation of orphan drugs in Turkey.

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A systematic review of moral reasons on orphan drug reimbursement

Zimmermann

Eichinger

Baumgartner

2021

Orphanet J Rare Dis

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Background The number of market approvals of orphan medicinal products (OMPs) has been increasing steadily in the last 3 decades. While OMPs can offer a unique chance for patients suffering from rare diseases, they are usually very expensive. The growing number of approved OMPs increases their budget impact despite their low prevalence, making it pressing to find solutions to ethical challenges on how to fairly allocate scarce healthcare resources under this context. One potential solution could be to grant OMPs special status when considering them for reimbursement, meaning that they are subject to different, and less stringent criteria than other drugs. This study aims to provide a systematic analysis of moral reasons for and against such a special status for the reimbursement of OMPs in publicly funded healthcare systems from a multidisciplinary perspective. Results With a systematic review of reasons, we identified 39 reasons represented in 243 articles (scientific and grey literature) for and against special status for the reimbursement of OMPs, then categorized them into nine topics. Taking a multidisciplinary perspective, we found that most articles came from health policy (n = 103) and health economics (n = 49). More articles took the position for a special status of OMPs (n = 97) than those against it (n = 31) and there was a larger number of reasons identified in favour (29 reasons) than against (10 reasons) this special status. Conclusion Results suggest that OMP reimbursement issues should be assessed and analysed from a multidisciplinary perspective. Despite the higher occurrence of reasons and articles in favour of a special status, there is no clear-cut solution for this ethical challenge. The binary perspective of whether or not OMPs should be granted special status oversimplifies the issue: both OMPs and rare diseases are too heterogeneous in their characteristics for such a binary perspective. Thus, the scientific debate should focus less on the question of disease prevalence but rather on how the important variability of different OMPs concerning e.g. target population, cost-effectiveness, level of evidence or mechanism of action could be meaningfully addressed and implemented in Health Technology Assessments.

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Ethical Overview of Pharmaceutical Industry Policies in Turkey from Various Perspectives

Cited by 5 publications

References 6 publications

Analysis of Patient Access to Orphan Drugs in Turkey

Analysis of Patient Access to Orphan Drugs in Turkey

Analysis of patient access to orphan drugs in Turkey

A systematic review of moral reasons on orphan drug reimbursement

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