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Switzerland - EU relations


With its Europe Roadshow Interpharma aims to raise awareness of the bilateral accords

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Switzerland - EU relations


With its Europe Roadshow Interpharma aims to raise awareness of the bilateral accords

Bilateral agreements and immigration, survey by gfs.bern, April 2016.

Bilateral agreements and immigration, survey by gfs.bern, April 2016.

As a small economy, Switzerland is dependent on good market access to the EU, especially since more than half of all Swiss exports go to Europe. And more than half (55%) of pharmaceutical exports also go to other European countries. Bilateral Agreements I made market access substantially easier thanks to the dismantling of technical trade barriers. The agreement on the freedom of movement for people is also key, because the recruitment of qualified specialists at every level not only in the EU, but also globally, is crucial for a great many industries, and especially for the research-based pharmaceutical industry. The workforce potential for this is too small in Switzerland alone.

PRAGMATIC IMPLEMENTATION OF THE MASS IMMIGRATION INITIATIVE

The vote in favour of the mass immigration initiative on 9 February 2014 puts the bilateral agreements as a whole at stake. These agreements are crucial for the research-based pharmaceutical industry in Switzerland. Interpharma advocates for a pragmatic implementation of the initiative, the primary objective of which must be to preserve the Bilateral Agreements I.

EUROPE ROADSHOW

In parallel with these efforts, Interpharma seeks to feel the pulse of the general public on relations between Switzerland and the EU and to increase awareness of the importance of good relations with our European neighbours. With this in mind, Interpharma again commissioned the research institute gfs.bern in April and May 2016 to conduct a representative opinion poll on the relations of Switzerland with the EU, the results of which were prominently reported on in the media. Two series of polls had already been conducted in 2015, which were likewise taken up by numerous media outlets.

In collaboration with swissuniversities and cantonal chambers of commerce, Interpharma also launched a roadshow with which the pharmaceutical industry and universities engage in dialogue with stakeholders and interested members of the general public on issues around Switzerland as a pharmaceutical and research hub as well as the importance of the bilateral accords. During this roadshow, representatives from the worlds of politics, business and research discuss the importance of good relations with Europe. The first stop was Lucerne in September for a stakeholder event. Both a stakeholder event and a public evening event were held in Zurich on 21 November. In this coming year further events will follow in Solothurn, Zug, Lausanne and Fribourg.

 

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Corporate tax reform (CTR III)


Interpharma advocates for an attractive tax environment

Corporate tax reform (CTR III)


Interpharma advocates for an attractive tax environment

USR III: the present tax attractiveness of Switzerland should be preserved. © Barbara Jung

USR III: the present tax attractiveness of Switzerland should be preserved. © Barbara Jung

Corporate Tax Reform III, which was adopted by both houses of parliament in June 2016, is intended amongst other things to provide alternative mechanisms to take the place of the cantonal special status for holding and management companies, which are no longer in keeping with international standards are to be abolished. As compensation, a new patent box is to be included in the cantonal tax regimes, which will provide for a privileged treatment of income from patents and other intellectual property rights that are attributable to research and development in Switzerland. The cantons are also to have the possibility of additionally allowing increased deductions for R&D expenditure. A referendum has been called against the reform. The referendum vote will take place on 12 February 2017.

Interpharma welcomes the bill and is committed to supporting the tax attractiveness of Switzerland as a business location. The tax reform boosts domestic research and development and ensures that all companies will be uniformly taxed in the future.

 

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New pricing system


The new pricing system takes greater account of the benefits

New pricing system


The new pricing system takes greater account of the benefits

At the beginning of July, the Federal Council presented regulatory amendments for a new pricing system for reimbursable medicines and submitted them to the consultation process. The amendments are made necessary following a ruling by the federal court, which in December 2015 found in the last instance that a review of cost effectiveness by means of international reference pricing (IRP) alone is not permissible and must be more broadly based using therapeutic reference pricing (TRP). The latter must be considered both in the first price-setting procedure and also in regular price reviews. The federal court further found that that not only the cost effectiveness of all medicines in the Specialties List (SL) must be regularly reviewed, but also their efficacy and fitness for purpose.

With a greater focus on the benefits, innovation will be better rewarded.   © Barbara Jung

With a greater focus on the benefits, innovation will be better rewarded.  
© Barbara Jung

The regulatory amendments submitted to the consultation process by the Federal Council provide for future use and equal weighting of the IPR and the TPR both when medicines are included in the SL for the first time and in subsequent price reviews. The previous upper limit is also to be abolished. A further change is that a TPR is now to be conducted also in the price review after patent expiry.

As a result of the changes, no price review round was held in 2016.

Interpharma welcomes the changes

Interpharma welcomes the regulatory changes in principle, but requests amendments of two important points. Interpharma takes a particularly positive view of the greater weighting of the TPR and hence the reduced dependence on the IPR. Also to be welcomed is the 1:1 weighting of the IPR and the TPR and the abolition of an upper limit (IPR plus 5%). Finally, it is also right to maintain the frequency of reviews at every three years. Interpharma notes with regret, however, that purchasing parity is still not considered in pricing and that price adjustments are still only possible to the disadvantage of the pharmaceutical companies (asymmetry).

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Innovative price models


Interpharma calls for more flexibility in the pricing system

Innovative price models


Interpharma calls for more flexibility in the pricing system

Interpharma is actively engaged with its member companies seeking to develop new, innovative price models especially in the area of combination therapies and in the differing medical benefit in different indications of the same medicine. As a result of the rapid advances in medicine, especially in oncology, greater flexibility in needed in the established pricing model to make sure patients can also continue to have access to the latest treatments. Interpharma is engaged in dialogue with health insurers about reimbursing the cost of innovative combination treatments in oncology. Thanks to this dialogue, three combination therapies were included in the Specialties List (SL) in spring 2016. Interpharma remains committed to finding flexible and pragmatic solutions to secure access to the latest treatments.

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Revision of Therapeutic Products Act (TPA)


Research incentives in the area of intellectual property are boosted

Revision of Therapeutic Products Act (TPA)


Research incentives in the area of intellectual property are boosted

After discussions lasting several years, the two houses of parliament approved the second partial revision of the Therapeutic Products Act in the spring session of 2016. The deadline for the referendum passed without action. For the research-based pharmaceutical industry, this revision touched on four key areas:

1. RESEARCH INCENTIVES IN THE AREA OF INTELLECTUAL PROPERTY

Research incentives have been boosted in the field of intellectual property. © Barbara Jung

Research incentives have been boosted in the field of intellectual property.
© Barbara Jung

The two houses of parliament (the National Council and the Council of States) decided that a ten-year period of data protection should be granted in the case of new indications for medicines with known active ingredients, provided that significant clinical benefit can be expected compared with existing treatments and that evidence of this can be shown through extensive clinical trials. It was further decided that, for paediatric medicines, either an extension of an existing supplementary protection certificate or a separate six-month protection certificate should be granted. The two houses disagreed on the question of medicines for rare diseases (orphan drugs). The National Council wanted to promote the development of such products by granting ten-year market exclusivity, as has been the case for some time already in the USA and the EU, whereas the Council of States wanted data protection of 12 years or 15 years in the case of paediatric indications. After the 2015 autumn session, signs of a possible compromise began to emerge: The National Council health commission proposed waiving the instrument of market exclusivity and providing for a general data protection of 15 years instead, thus accommodating the Council of States position. Before this, during the debate in the Council of States, the Federal Councillor responsible had signalled his support for a general data protection of 15 years for orphan drugs. Eventually, both houses decided the institute must publish applications for market authorization in future and thus establish transparency in the market.

In the run-up to and during the debate, Interpharma campaigned for greater research incentives in the area of intellectual property. With data protection for new indications with known active ingredients, Switzerland will assume a pioneering role and reinforce its position as a centre for research.

 

2. Tougher sanctions in cases of pharmaceutical crime

Both houses of parliament voted in favour of much tougher sanctions in cases of pharmaceutical crime and adopted an article that now makes pharmaceutical crime an abstract endangerment offence. In addition, a provision was explicitly introduced into law that also makes the imitation, falsification or false designation of human medicinal products and medical devices a criminal offence.

Interpharma has been engaged for years in the fight against pharmaceutical criminality and is also active in the STOP PIRACY association, which campaigns against counterfeiting and piracy. In terms of patient safety there has to be zero tolerance to the counterfeiting of medicines. To this extent Interpharma welcomes the tougher sanctions adopted in the fight against pharmaceutical crime.

 

3. REGULATION ON TRANSFER OF VALUE

The National Council corrected the unsuccessful article of the Federal Council, which provided for a ban on transfers of value and opted for a different approach by adopting an integrity article which rules that service providers may not accept or demand any undue advantages or accept the promise of such advantages. The Council of States largely followed this approach.

Interpharma has campaigned for a practicable regulation that is fit for purpose to be implemented in order to regularize relations between the pharmaceutical industry and other service providers.

 

4. PRODUCT INFORMATION

On the question of who should publish medicinal product information in future, the two houses of parliament approved a stakeholder solution, which Interpharma is/was actively involved in helping to elaborate. This means that responsibility for the publication of these data will no longer lie with Swissmedic, but with a foundation supported by the pharmaceutical industry, medical professions and patient organization. Interpharma welcomes this stakeholder solution.

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HTA


Interpharma becomes engaged in the area of HTA

HTA


Interpharma becomes engaged in the area of HTA

Together with santésuisse, Interpharma has initiated the stakeholder project SwissHTA, which has the backing of the Swiss Medical Association (FMH) and the Swiss Academy of Medical Science (SAMS) with the federal government in the role of observer. A consensus was worked out here for the drafting of Health Technology Assessments (HTAs) in Switzerland. In 2015, SwissHTA formally joined the sponsoring association of the Swiss Medical Board (SMB), after a convergence process had been initiated in 2014 in order to unify the approaches of these two projects to the way benefits are assessed.

Proposals of Interpharma for a broad-based approach

In May 2016, the Federal Council decided to reinforce the HTAs and to have medical services systematically and regularly assessed for their benefits. Interpharma had advocated that the originally intended federal law on a centre for quality in compulsory health insurance, which was to have conducted not only quality assurance reviews but also HTAs, should not be pursued any further, after numerous stakeholders – including Interpharma – had voiced their criticism in the consultation process. The areas of Quality and HTAs are now to be handled separately. The Federal Office of Public Health (FOPH) will also set up an HTA unit of its own. Stakeholders can submit proposals on health services to be examined. Interpharma has submitted several proposals both for 2016 and for 2017 and also commented on HTA reports. The questions submitted pursue a comprehensive approach to reduce inappropriate provision, overprovision and underprovision. Interpharma has argued for years in favour of this kind of broad approach.

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Efficient procedures


Interpharma campaigns for short procedural processes and keeps a constant check on them

Efficient procedures


Interpharma campaigns for short procedural processes and keeps a constant check on them

To ensure that patients have prompt access to innovative medicines and to preserve the attractiveness of Switzerland as a pharmaceutical industry hub, efficient regulatory approval procedures with the Swiss Therapeutic Products Agency Swissmedic are just as essential as rapid procedures for the inclusion of new medicines in the Specialties List (SL) of the Federal Office of Public Health (FOPH). Interpharma monitors the timelines of both procedures.
 

Patients should benefit from faster access to innovative medicines. © Barbara Jung

Patients should benefit from faster access to innovative medicines.
© Barbara Jung

APPROVAL TIMES AT SWISSMEDIC

Interpharma has carried out a benchmark study together with the other industry associations and Swissmedic for several years, measuring regulatory approval times at Swissmedic. The results are compared with the approval times of the US regulatory authority (FDA) and the medicines agency of the EU (EMA).

FASTER PROCEDURES FOR THE ADOPTION OF MEDICINES IN THE SL

Interpharma also measures the times taken to approve medicines for inclusion in the SL. In June 2013, ordinance amendments came into force designed to accelerate the inclusion of new medicines in the SL. As a rule, this procedure should be completed within 60 days of the medicine being granted marketing authorization by Swissmedic. This acceleration was part of an agreement between the pharmaceutical industry and the Federal Department of Home Affairs (FDHA), which was concluded in April 2013. In return, the pharmaceutical companies committed to withdraw all pending appeals concerning a system in the change for reviewing the prices of medicines and not to lodge any new appeals.

Interpharma campaigns to ensure that these target times are actually observed and monitors them accordingly. Since the new regulation was introduced, the number of applications processed within these 60 days has increased. However, since the new price-setting rules came into force in July 2015 the timelines are observed much less often and only a small proportion of the applications are processed within 60 days.

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Rare diseases


Implementation of the Rare Diseases concept continues to raise a lot of questions

Rare diseases


Implementation of the Rare Diseases concept continues to raise a lot of questions

The research-based pharmaceutical industry in Switzerland is right at the forefront of research and development in the field of rare diseases.  © Barbara Jung

The research-based pharmaceutical industry in Switzerland is right at the forefront of research and development in the field of rare diseases. 
© Barbara Jung

In May 2015, the Federal Council approved the plan to implement the national concept for combating rare diseases. The concept had been called for in a proposal put forward by National Councillor Ruth Humbel (CVP). As a member of IGSK (an interest group for combating rare diseases), Interpharma lends its backing to the implementation of the concept, which should be completed by 2017. While Interpharma supports the implementation in principle, key questions have yet to be settled, such as the funding of measures, the promotion of research and binding steps for equal rights in the reimbursement of costs for diagnoses and treatments.

 

 

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Masterplan


Interpharma supports implementation of the master plan with constructive criticism

Masterplan


Interpharma supports implementation of the master plan with constructive criticism

Master plan for biomedical research and technology, Federal Department of Home Affairs, 2013.

Master plan for biomedical research and technology, Federal Department of Home Affairs, 2013.

Interpharma lends critical, but constructive support to implementation of the master plan for strengthening biomedical research and technology, which was published in December 2013. Elements already implemented include accelerated procedures for inclusion in the Specialties List (as a rule 60 days after Swissmedic approval), the Swissmedic strategy for efficient marketing authorization procedures, faster approval procedures for clinical trials and the pricing system which came into force in June 2015, but which has to be revised as the result of a federal court ruling. Interpharma is following the implementation and measuring the progress made, for example, time it takes to approve medicines for reimbursement. Since the new pricing system came into force in June 2015 (which is already under revision again however) increased delays have been noted again.

Major need for action on ethics committees

Progress has been made in certain areas, but in other areas there is still major need for action, for example when it comes to the protracted procedure for the approval of clinical trials by the ethics committees. Here, amongst other things, there has been massive failure to comply with the schedules enshrined in law, and the newly introduced lead principle, by which only one ethics committee materially reviews a research application, is not being properly respected. Interpharma is actively engaged in efforts to establish a new, additional (fast-track) procedure for the approval of clinical trials for medicines in clinical phases 1, 2 and 3, which is assigned to a centralized or one of the existing ethics committees.