Supply chain commitment to tackling problem of medicine shortages
Monday, 05 March 2018 21:04    PDF Print E-mail

Medicines

The European associations representing manufacturers of medicinal products, parallel distributors, healthcare distributors and pharmacists welcome pan-European efforts by the Heads of Medicine Agencies1, the European Medicines Agency, the Council2 and the European Commission3 to address medicine shortages. Supply chain stakeholders believe that the long-term resolution of medicines shortages is dependent upon collaborative and unified actions. We therefore call for the inclusion of the supply chain actors in the abovementioned initiatives organized by Governments and the regulatory community. Ahead of the Bulgarian Presidency event ‘Health as the Real Winner: Presidency conference on options to provide better medicines for all’ on 6 March in Sofia, supply chain stakeholders call for their greater involvement in discussions about medicines shortages. Specifically, supply chain stakeholders wish to make the Health Ministers aware of an existing collaboration on this crucial issue, created with the objective of helping to mitigate the impact of shortages. Furthermore, supply chain stakeholders strongly believe that the input, perspectives and experience of the variety of stakeholders affected by the issue of shortages needs to be sought and taken on board to reach best-informed conclusions. The supply chain partners have set up an informal working group in 2015 and published a set of recommendations in early 20174 calling for greater transparency and availability of medicines shortage data, early detection and assessment of potential shortages, consistency of reporting, increased access to the information available across all parts of the supply chain, improved data infrastructure, and collaborative stakeholder governance processes.

The Associations’ statement4 is part of their wider commitment to tackling the increasing problem of shortages across the European Union, having a significant impact on patients, health professionals, healthcare systems and manufacturers and distributors.

 
Merry Christmas!
Sunday, 24 December 2017 16:11    PDF Print E-mail
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Държавата следва да наказва с цялата тежест на закона нелегалната търговия с лекарства, но и да стимулира легалния бизнес в сектор Здравеопазване
Monday, 04 December 2017 14:52    PDF Print E-mail
There are no translations available.

 

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Държавата следва да наказва с цялата тежест на закона нелегалната търговия с лекарства, но и да стимулира легалния бизнес в сектор Здравеопазване

 

Законодателната недостатъчност в съчетание с постоянния натиск за намаляване на цените и маржовете на лекарствата, стимулират сивата икономика и криминалните схеми в сектора на грижа за здравето

 

Фармацевтичният бизнес в България се обявява категорично в подкрепа на действията на държавата срещу нелегалния износ на лекарства. Компаниите -стратегически инвеститори в сектора на здравеопазването обаче уточняват, че това е само първа стъпка и нелегалният износ на лекарства следва да бъде криминализиран чрез нарочни промени в Наказателно-процесуалния кодекс. Основният закон в наказателното право у нас към момента не адресира разпространението на фалшифицирани лекарства, каквито по смисъла на закона са всички продукти, продавани извън регламентираната верига на лекарство-снабдяване.

Осъществената преди 3 дни акция на държавните органи показва по недвусмислен начин, че злоупотребите в сектора са причинени именно от криминални лица и предприемането на законодателно-административни мерки срещу тях е безсмислено след като тези лица и фирми не спазват и не зачитат закона изначално.

За намирането на ефективно решение е необходим задълбочен анализ на причините за наличието на нерегламентиран износ. А той показва, че е на лице комплексно действие на много фактори - законодателна недостатъчност, ограничен ресурс на държавните органи да контролират фирми-еднодневки, постоянен натиск за намаляване на маржове и цени на лекарствата, ниско заплащане на специалистите в здравеопазването и много други.

Обединеното действие на всички държавни органи, така както беше направено в проведената акция, обаче остава еднократно действие, което е преборило един симптом, но не е решение на причината за „заболяването“. Разкрита е една групировка, но не са премахнати причините утре да се появи следващата.

Затова фармацевтичната индустрия, която спазва стриктно буквата на закона, отговаря на най-високите международни стандарти, има репутация и ясна роля в обществото, призовава за ефективни мерки срещу сивата икономика и криминалните практики. Категорично ясно е, че в тази ситуация именно стабилните бизнес структури, които единствени могат да изнесат икономическата тежест на сектора при гарантирано спазване на всички закони и прилагане на високи етични принципи, се явяват крайно необходим стратегически партньор на държавата.

За трайно решение е нужен нов подход – въвеждане на ефективни промени в НПК за преследване и наказание на подобни практики с най-голямата строгост на закона.

От друга страна либерализиране на законодателството в сектор Здравеопазване, което да подкрепя икономиката и развитието на бизнеса през мащаб, а не чрез натиск върху цени и маржове при малкия обем и ниска покупателна сила на българския пазар. Не трябва да забравяме, че основната роля на държавата е да стимулира икономиката, която инвестира, създава работни места и дава професионално бъдеще на нацията.

 
Interview Olia Vassileva – Executive Director, Bulgarian Association of Pharmaceutical Wholesalers (BAPW), Bulgaria
Wednesday, 25 October 2017 15:01    PDF Print E-mail
There are no translations available.

Interview

Olia Vassileva – Executive Director, Bulgarian Association of Pharmaceutical Wholesalers (BAPW), Bulgaria

23.10.2017 / Pharmaboardroom

Olia Vassileva, executive director at the Bulgarian Association of Pharmaceutical Wholesalers (BAPW), gives a clear explanation of the challenges facing wholesalers in Bulgaria, its current as well as future role in the healthcare system, and its true commitment towards patient safety.

As an introduction, please briefly explain the main activities and responsibilities of the Bulgarian Association of Pharmaceutical Wholesalers (BAPW).

“Parallel exports are a completely legal and regulated business within the EU but it is clear that this is creating pressure due to the product deficit on the market.”

BAPW is the Bulgarian representative trade association whose mission is to advance the interests and values of those member companies who provide healthcare distribution, comprehensive medicine wholesaling and associated services to all Bulgarian pharmacies, hospitals, and healthcare institutions. The foundation companies of the Association are among the leaders of the pharmaceutical market in Bulgaria with more than 60 percent of market share of the public medicine supply. This leading market role and its forthcoming responsibilities, urge on to undertake an active public position regarding the development of the Pharmaceutical sector in Bulgaria.

Ms. Vassileva, you were appointed as Executive Director of BAPW in 2010. What are the key priorities on your agenda to ensure the success of BPAW’s mission?

Over the past few years, the need for better allocation of government budgets across Europe has been a constant pressure on the margins for the players in the pharmaceutical chain. Hence, wholesalers are becoming more active players on the pharmaceutical market building their own pharmacy chains, offering their own brands and developing innovative services for the end users. On a local level, healthcare distributors should anticipate trends by developing new types of representation, which guarantees that the basic European principles are adhered and that Bulgarian patients have access to world-class quality and innovative services.

The pharmaceutical sector has been one of the fastest growing economic areas in Bulgaria with steady annual growth rates of 7-10 percent during the last decade. To what extent have your company members been benefitting from this positive trend?

In 2016, despite the high regulatory dynamism, the pharmaceutical market maintained its growth rate of nearly 8 percent in value. However, it is important to mention that Rx margins are at a critical minimum level of 73 percent for manufacturers, 3 percent for medicine wholesalers, 7 percent for pharmacies and 17 percent for VAT. Hence, wholesalers’ margins are the lowest across the total value of the medicinal products. It simultaneously bears the main financial burden, insofar as it represents the buffer between the manufacturer of the medicinal product and the retailer or the healthcare facility – which receives funds for the granted medical products/the implemented activity from the NHIF over a defined period of time and after an audit has been conducted. At present, the gross margin for wholesalers is closer to the “sanitary” minimum, which still allows the wholesaler to conduct business.

What are the main concerns of pharmaceutical wholesalers in Bulgaria?

The main challenges we have faced over the past few years were the constant regulations for reductions in the price of medicines, cutting costs in the field of healthcare, and in particular, the reduction of the NHIF budget deficit. These measures have an indirect influence on pharmaceutical wholesalers since the price pressure on manufacturers is transferred along the entire chain to distributors and pharmacies.

Furthermore, wholesalers in Bulgaria are a big creditor to the healthcare system, which is a big challenge for us. Additionally, the level of high inter-company indebtedness has remained stable and in the pharmaceutical sector it is mainly caused by underfunding hospitals, the economic instability and the insufficient public resources for the purposes of healthcare.

Unfortunately, in the short term, I do not expect any change in the indebtedness of hospitals and the total exposure to the distributor members of BAPW exceeds BGN 150 million (USD 90 million). This is a serious debt that cannot be covered without creating a long-term framework for the purpose of optimizing medical activities, expenditure analysis and increasing internal control in hospitals. This is a social issue and we closely work with every hospital in order to find the best solution for debts without this influencing patients’ access to healthcare.

But to continue on a more positive note, the Ministry of Health has begun to view wholesalers as strategic partners, which have been funding the system for years on end. I hope the team at the Ministry of Health will take long-term action for improving the status of the hospital market.

What specific steps should pharmaceutical wholesalers undertake in order to overcome the squeezed margins situation?

BAPW member companies need to collaborate in a more effective way, to improve service to customers up and down stream and increase the profit in the value chain required for reinvestment.

Technology can certainly create efficiency as well as efficacy improvements on this front. How are your members embracing the latest technologies in their operations?

Healthcare distribution embraces new technologies. Automation is high, delivering efficient order consolidation processes that arguably make our members some of the most proficient companies operating in the sector globally. Such efficiency brings great value to our partners. Further technological advancements are already under way. Hub and spoke, cold chain distribution, and the latest robotic developments ensure that our members are at the forefront of the industry.

The spirit of collaboration has been evident among Government, associations, patients, and industry. How is this sectorial collaboration philosophy reflected in BAPW operations?

The pharmaceutical stakeholders are key partner to the Ministry of Health in providing health services to patients. But it’s true that it’s a challenge for both sides to synthesise and find that golden ratio between the various interests in the sector. From our side, as an association, we are always willing to offer our full expert potential and resources in support of the effort of the government to implement reforms in the area of healthcare and to improve the efficiency of managing the processes in hospital aid and the expenditure of public funds. In this regard, we are grateful to the Ministry of Health for the open dialogue and their partnership and we hope we can continue this constructive communication for the good of the patients.

Parallel exports represent around 10 percent of the national pharmaceutical value and are jeopardizing patients’ access to highly needed medicines. What is the positioning of BAPW within such debate?

Parallel exports are a completely legal and regulated business within the EU but it is clear that this is creating pressure due to the product deficit on the market. This is where the government comes in to find the right regulation model in compliance with European legislation that will ensure access to medicine for the Bulgarian patient. We generally support the integration of a monitoring mechanism for certain medicinal products and for limiting their export when a deficit is established, which constitutes a threat to the life and health of Bulgarian patients under Article 36 of the Treaty on the Functioning of the European Union. The Ministry of Health has made commendable effort to create a mechanism for tracking the movement of medicines within the Bulgarian territory but only an electronic system could provide a transparent and effective process of such tracking.

What are the most prominent initiatives that BAPW is currently implementing to defend the interests of the member companies?

Currently, we are focused on the establishment of modern conditions for the development of pharmaceutical products and/or medical devices wholesale in compliance with the principles of Good Distribution Practice and all the factors that determine the optimum economic activity through the implementation of operational standards among BPAW’s members for professional and commercial ethics, customer service and increasing security.

Related to the latter, the association focuses on developing a National System of verification of medicinal products in Bulgaria in order to prevent the distribution of counterfeit – The pharmaceutical sector has united its forces to develop a verification system, which can check the authenticity of medicinal products. I can proudly say that the Bulgarian Medicine Verification Organization (BgMVO) – founded by the five organisations which represent the stakeholders taking part in the manufacturing and distribution of medicinal products – is at the forefront of this purpose and it was the second one founded in Europe.

Additionally, other important project for us is the initiative of the Ministry of Health for introduction of a public procurement model for the supply of medicines funded through the inpatient treatment system, which is expected to happen very soon. Electronic tenders are a renowned practice in many countries and it is one of the tools for achieving transparency in the procedure of arranging and purchasing medicine for hospitals and also providing better prices. Hence, we are leading a constructive dialogue with institutions to provide our full expertise and resources in support the government in this front. We believe that such electronic system will be constructed in a manner that will ensure free and fair market competition, as well as seamless access to medicinal products for people with health insurance.

How is BAPW collaborating with its European counterparts?

We act as a conductor of European standards and practices for their implementation in Bulgaria through our membership in the European Healthcare Distribution Association (GIRP), the umbrella organisation for pharmaceutical full-line wholesalers and distributors of healthcare products and services in Europe.

GIRP, as the representative trade organisation for full-line wholesalers, is actively engaged in a wide range of safe supply chain initiatives: European Medicine Verification System, International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT), World Health Organisation, Council of Europe and European Union institutional activities and many more.

Looking forward, what makes you optimistic regarding both the future of pharmaceutical wholesalers in Bulgaria and the development of the country’s health system?

Our world is changing and our supply chains must change with it. I’m confident that BAPW members will continue being at the forefront of innovation and supply chain development driving and sharing best practices. Indeed, being a reliable partner in the supply chain we are delivering increasing value to our partners and to the healthcare.

Regarding the development of Bulgarian healthcare system, I am optimistic. Minister Petrov’s cabinet is known for its expertise and strong willingness and ability to change the system. I believe that when we are united we will succeed!

In a nutshell, what is your final message to our international audience?

As the vital link in healthcare, we are committed to developing and providing innovative and efficient healthcare products and services to improve health and wellbeing of patients, which is our main concern.

 
Потенциален риск пред достъпа до онко лекарства за българските пациенти
Tuesday, 13 June 2017 11:00    PDF Print E-mail
There are no translations available.

Потенциален риск пред достъпа до онко лекарства за българските пациенти

Новите разпоредби на Националния рамков договор за 2017 година влизат в сила със забавяния, проверки и ограничения в доставките на онкологични лекарства в страната

Юни 2017 / София

Компаниите членове на Българската Асоциация на търговците на едро с лекарства алармират за потенциален риск пред достъпа до онко лекарства на българските пациенти. През последния месец, с влизане в сила на някои разпоредби на Националния рамков договор за 2017 и най-вече тяхното недалновидно и чиновническо приложение от страна на Ръководството на НЗОК, се създаде критична ситуация при доставките на онкологични лекарства на болничен пазар. Става дума за удължаването на сроковете за заплащане на онколекарства от страна на НЗОК след влизане в сила на НРД за 2017 г. с до 30 дни поради проверки за спазване на наложеното изискване за обвързване на отчетено количество лекарствен продукт спрямо норма и телесно тегло на пациентите.

Така търговците на едро с лекарства в България, които от години са финансов буфер на болничен пазар, са поставени за пореден път в ситуация на безгласни кредитори. А, пациентите страдащи от онкологични или злокачествени заболявания са в риск от забавено лечение.

Дистрибуторите с лекарства оперират на силно регулиран болничен пазар, който от една страна ограничава до минимум надценката им, а от друга ги принуждава да кредитират болниците докато НЗОК им изплати извършените медицински дейности. В резултат на тази система, задълженията и просрочието на болници към БАТЕЛ и до влизане в сила на новите разпоредби, надхвърлят разумната граница на търговски риск. Към 31.03.2017 г. средното просрочие към членове на БАТЕЛ е 240 дни, а общият размер на всички задължения на държавни и общински болници е 513 млн. лв. (по данни на МЗ).

Въпреки тежките финансови условия, търговците на едро с лекарства спазват добросъвестно отговорността си към българските пациенти и затова до момента не са спирали доставки на живото-поддържащи и живото-спасяващи лекарства.

И в тази ситуация НЗОК добавя ново едномесечно забавяне и прави така, че тази сума да набъбне с още десетки милиони! Действие, което не може да бъде обяснено, нито с контрол на разходваните средства, нито с ефективност на управляван бюджет. И най-вече не може да бъде обяснено с грижа и мисъл за пациентите!

Затова компаниите членове на БАТЕЛ се обръщат с публичен апел да се преразгледат разпоредбите на НРД за 2017 година, свързани с доставки на онколекарства.  Илюзия е да се смята, че бизнесът може да поеме повече от тези 500 млн. лв. и е длъжен до безкрай да компенсира недалновидната държавна политика. Ако проблемът с плащанията и остатъчния срок продължи не може да се гарантира регулярно изпълнение на доставки на онкологичните лекарствени продукти. А, държавата за пореден път действа с бюрократично-административен подход, вместо да използва силата на бизнеса за градивно подобрение на болничен пазар. Например чрез инвестиции.

Управителен съвет

Българска Асоциация на Търговците на едро с лекарства

 
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