Availability of human medicinal products in Europe how big is the problem and what can we do?

Transcription

1 Availability of human medicinal products in Europe how big is the problem and what can we do? Kristin Raudsepp Director General Estonian State Agency of Medicines

2 The presentation Initiative by the regulators in Europe to gain better availability of medicines Report Follow-up questionnaire ICDRA

3 Companies are free to decide about market potentials and plan according to that their marketing strategy Patients, physicians, pharmacists need medicinal products Agencies balancing ICDRA

4 ICDRA

5 The Heads of Medicines Agencies The Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of Medicinal Products for human and veterinary use in the EEA The HMA aim to protect and promote public and animal health in Europe. ICDRA

6 Examples from Estonia Vaccines Approx 9% authorised national and MRP/DP products have not been available for more than 3 years Approx 60% centrally authorised products are not available ICDRA

7 The Task Force of the HMA MG on Availability of Human Medicinal Products It is clear that the availability issues are not only in the veterinary sector. MG decided to establish a task force to research the availability of medicines on the human side. Estonia Ms Kristin Raudsepp Chair of the TF Cyprus Ms Panayiota Kokkinou Iceland Ms Rannveig Gunnarsdottir Malta - Ms Patricia Vella Norway Ms Gro Wesenberg Slovenia Ms Martina Cvelbar ICDRA

8 Work in Initiative by the HMA MG in February 2007, formulation of the Task Force in February 2007, Work started in March 2007 First draft was discussed in HMA Lisbon Meeting in July 2007 Input and examples from 15 Member States Comments from many MSs, the EMEA, the EC, the industry Letter from HMA to the EC to raise the concern on availability in October 2007 The Report adopted by the HMA in November 2007 The Report from HMA was sent to the EC together with the proposal to make changes to the legislation in November 2007 Published on HMA website in January 2008 The Action Plan to the Report adopted by HMA in January 2008 Publicity (a special session in DIA Euromeeting in March 2008 together with patients organization, WHO) Discussion at the EC Pharmaceutical Committee 20 May 2008, Pricing Committee ICDRA

9 The Report... is looking at the current situations concerning the availability problems of medicinal products in the Member States; is highlighting the problems with implementing of current legislation; is offering a tool for exchanging views and good ideas on practical solutions; is proposing the solutions for the availability problems; is raising the awareness about the situation to decision-makers ICDRA

10 The Report doesn t look in detail into the issue of the low interest of companies to develop medicinal products for certain diseases.... doesn t look in detail into the issue of the pricing and reimbursement.... uses case studies and the situations in different Member States. Some cases may be common in more than one Member State concerned and others may be more specific. ICDRA

11 The structure of the Report Chapter 1. Introduction and Background What makes it happen Chapter 2. The Currently Available Regulatory Environment What are the available possibilities Chapter 3. Medicines Availability in the EU the Future. Conclusions and Recommendations What else is needed Appendices, concrete examples from MSs about availability problems and offered solutions ICDRA

12 Non-availability of a medicinal product the company has not applied for a MA of a certain product or a product with a valid MA is not placed on the market or there is a discontinuity in the availability Not all non-available medicinal products create a problem ICDRA

13 Discontinuity in the availability Temporary (mostly unintentional): the situation is mainly caused by difficulties in manufacturing or wholesaling. It may be short-term or long-term Constant (mostly intentional): the situation is caused by the decision of the company not to apply for marketing authorisation or not to put a product on a market in a Member State. If the product is necessary for the users, the drug regulatory authorities in these countries use several options for solving the situation. These will be discussed in this report. Absolute: The situation is caused by the low interest of the company in developing or manufacturing a necessary medicinal product. This situation is not covered by this report. ICDRA

14 The description of the main problem itself The authorisation for placing a medicinal product on the market is granted by the regulatory authorities of the Member State or the European Commission after an assessment by relevant expertise. ICDRA

15 The description of the main problem itself, cont...d However, this authorisation can only be issued after the manufacturer has applied for it. This concept works well in an ideal world where the manufacturers are interested to place their products equally to all the markets, but in reality this may not be the case If such situation happens, we can see that there are not enough instruments for the governments to handle and solve such situations. ICDRA

16 Industry s view on main constraints and limitations Only economical ICDRA

17 Concerns of a drug regulatory authority Possible public health concern, unsecure regulatory situation, more efforts to make ICDRA

18 Affected and/or non-attractive markets Main reasons for a country to be a non-attractive market for the pharmaceutical industry are: Size of the market Language of the country Need for upgrading the dossiers in MS accessed EU in 2004 and later The combination of different prices and parallel import/export may be one of the reasons for availability problems in certain markets that is not due to the size of the market ICDRA

19 Consequences of non-availability Patients, physicians, health budgets, regulatory authorities The consequences for the patients will depend on the severity of the illness and the availability of generic or therapeutic alternatives. There are also financial consequences for the patients connected with the use of unauthorised products ICDRA

20 Consequences...cont..d The lack of availability of medicinal products results in patients buying products directly from other countries or over the Internet, thus jeopardizing the safeguarding effect of the EU regulatory framework Time and resource consuming procedures in the regulatory authorities to handle the situations ICDRA

21 Currently available legislative -; measures A number of specific provisions of the Directive 2001/83/EC and the Regulation (EC) 726/2004 The Specialties provision: article 5. The Sunset clause: article 24, paragraph 4, 5 and 6 - The provision on Continuous supply: article 81, second paragraph - The Cyprus clause: article 126a Compassionate use for patients with chronic, serious or life-threatening disease: Compassionate use through an approved clinical trial protocol ICDRA

22 Some possibilities are in the legislation, but in practice they are not working as planned ICDRA

23 How we concluded the Report Not all medicinal products are made available in the markets of all Member States. MS with small markets face significant problems of drug availability, especially with products of low volume, low price as well as specialised products indicated for the treatment of severe and/or rare diseases. Current legislative and regulatory measures should be strengthened. Current legislation may be unclear on some points. Legislation in this domain has been intended to respond to isolated public health cases. ICDRA

24 How we concluded... 2 Availability problems have consequences for patients, physicians, health budgets, regulatory authorities Authorities in MSs have found various solutions to the issue. Some of them are described in the report MSs are obliged to participate in CP; the industry does not market on all EU markets. Costs of regulatory procedures do not significantly influence decisions on authorization. ICDRA

25 How we concluded..., 3 Patients` needs should be the priority of the pharmaceutical acquis. This is not always entirely compatible with the philosophy of the acquis concerning applicant's right to choose "suitable" markets (patients?) for marketing their products. The industry s decision to market on a particular market is unconditionally supported by the acquis. Incentives for industry are not accompanied by obligation concerning availability. Industry seems to be always in a dominant position, particularly in the case of small markets ICDRA

26 How we concluded...4 In order to gain access to otherwise unavailable medicines, patients often resort to risky behaviours that may encourage the proliferation of counterfeit products and jeopardize the principles of quality, safety and efficacy officially intended by the legislation. Such practices and methods result in adverse consequences of the legislation. There are not enough legal provisions to cover drug shortages in the market of Member States. Many of the provisions available are difficult to implement and enforce. Being active and working diligently in the European market processes, does not help small countries to get products on their own. ICDRA

27 How we concluded...5 Being a small country with unique language is a luxury..for which you have to pay ICDRA

28 Recommendations 30 recommendations, some very ambitious requiring much effort, some simple 1. Taking relevant measures and making necessary decisions on national level. Improving the implementation of the current legislative framework. 2. Proposals for changes to the EU legal framework ICDRA

29 HMA proposal to the EC Current legislation may be unclear on some points. Legislation in this domain has been intended to respond to isolated public health cases, but the reality of the situation is often different. The existing legal framework is not sufficient to solve the problem, so it is necessary to introduce changes to it in terms to ensure that availability of medicinal products should, under agreed conditions, be treated as the obligation of manufacturers/mahs. HMA proposes that Commission take the initiative and introduce changes to the existing legal framework in order to ensure availability of medicinal products, necessary for the protection of health. ICDRA

30 Follow-up questionnaire Sent out to all the HMAh in April answers from Austria Estonia Latvia Portugal Belgium Finland Liechtenstein Romania Bulgaria France Lithuania Slovenia Czech Republic Germany Malta Spain Cyprus Iceland Netherlands Sweden Denmark Ireland Norway United Kingdom From 27MS + 3 EEA it makes 80% ICDRA

31 Have you had any availability problem of human medicinal products in your country as to the knowledge of your agency? YES - 20 MS (83 % of respondents) + very many interesting cases, lots of similarities NO - 2 MS 1 MS only in rare cases, esp vaccines 1 MS no data ICDRA

32 Good practices, other measures dialogue with stakeholders to get information on availability problem early enough motivating manufacturers to authorise and market necessary product in country parallel import/distribution introducing language provisions exemptions allowing multilingual labelling motivating pharmacists to prepare magistral formulas for single patients and small scale production national pricing and reimbursement measures with the concrete target to ensure availability of a concrete product reduction of fees for MA procedures use of central government procurement establishing national early warning system on availability of particular medicines establishing national crisis management plan for use of alternative products within short time periods publishing of stock shortages ICDRA

33 What will happen next better implementation of the existing provisions; Sharing good practices between MSs and co-operation on the issue E-forum on availability or forming a permanent contact list or WG; information from Heads of Agency to the Health Ministers of the MS to get their support in the Council of Ministers; call on Commission to improve the existing provisions and to propose new provisions Commission Communication; follow up at the HMA meeting in the beginning of 2009 ICDRA

34 Conclusion The availability problem in EU is not the problem of the small countries only. The problem of availability of medicines is much more widespread in the EU that we initially estimated The countries who have identified availability problems have implemented the possibilities from EU legislation it helps, but it is not enough. There is a small room for improvement of implementation of the existing provisions that concern availability of medicines. The existing provisions have a very limited impact on solving the problem of availability Drug regulatory authorities in the MS have one additional function, probably not mentioned in the EU legislation or their statutes it is the logistical centre for gathering information and solving availability crisis Co-operation between MSs is welcomed ICDRA

35 Thank you very much for interest ICDRA