|Implemented in this survey?|
A reform on Finnish pharmaceutical legislation prepared by the Ministry of Social Affairs and Health aims to contain pharmaceutical expenses, to improve certain operational preconditions of pharmaceutical companies, to promote the use of nicotine replacement products, and to comply with the European Union legislation.
The Ministry of Social Affairs and Health (MSAH) has prepared a reform concerning the law on pharmaceuticals and the law on the National Health Insurance (NHI). The reform includes several changes
for the current state of affairs. The objective of the reform is to contain pharmaceutical expenses, to improve some operational preconditions of pharmaceutical companies, to promote the use of
nicotine replacement products, and to implement the changes in the Directive 2001/83/EC of the European Union on the Community code relating to medicinal products for human use in Finnish
The suggested reform contains following proposals:
The National Agency of Medicines grants the licences for pharmacists to operate retail pharmacies. The reformed legislation would more explicitly state criteria according to which the licences are granted.
To contain pharmaceutical expenses, to promote the use of nicotine replacement products, to improve certain operational preconditions of pharmaceutical companies, and to comply with changes in EU directives.
Main incentives of the reform are
Patients, The Pharmaceutical Pricing Board, Pharmaceutical Industry, Pharmacies
|Medienpräsenz||sehr gering||sehr hoch|
The reform improves the possibilities to contain pharmaceutical expenditure in Finland. However, further reforms are needed, such as renewing the categorisation of drugs and diseases into basic and special (high) reimbursement categories. The categories were mainly defined in the 1960s and 1970s drawing from assessment of the time on the chronicity of conditions and substantial pharmaceutical expenditure incurred due to their treatment.
The main proposed changes for Finnish pharmaceutical legislation are in line with a long standing policy of the Ministry of Social Affairs and Health to contain drug expenses. Some changes are proposed to comply with EU legislation. The pharmaceutical companies have pressurised the government to limit generic substitution which has been very effective in promoting price competition and reducing the prices of pharmaceuticals.
|Implemented in this survey?|
The main actor is the Ministry of Social Affairs and Health, which has also been main driving force behind the reform. The objectives are to contain pharmaceutical expenses, to promote the use of nicotine replacement products, to improve some operational preconditions of pharmaceutical companies and to comply with European Union legislation changes. Several components of the reform have been discussed earlier.
The approach of the idea is described as:
The Ministry of Social Affairs and Health has had a leadership role in designing the reform. The majority of relevant stakeholders in health care are positive or neutral towards the reform.
Perhaps the most controversial proposal is the sale of nicotine replacement products in grocery and other retail shops selling tobacco products. This is fiercely criticized by pharmacists, for whom the sale of nicotine replacement products is rather profitable business. They may also anticipate that this is the first step to allow the sale of other over-the-counter products outside pharmacies.
Pharmaceutical industry has strongly opposed the 5% reduction of maximum wholesale prices.
Some pharmaceutical policy experts connected to the government has criticised the restrictions for generic substitution claiming that the restrictions would only benefit pharmaceutical companies and not patients or the public health care system. According to the proposal, generic substitution would not be aplied to the drugs which have a process but no product patent in Finland, and which also have been granted a product patent at least in five European countries.
The patient organisations have somewhat opposed the changes of the reimbursement levels. However, financial implications for patients are rather small.
|Government||sehr unterstützend||stark dagegen|
|Parliament||sehr unterstützend||stark dagegen|
|Patients||sehr unterstützend||stark dagegen|
|Privatwirtschaft, privater Sektor|
|Pharmaceutical Industy||sehr unterstützend||stark dagegen|
|Pharmacists||sehr unterstützend||stark dagegen|
If accepted by the Parliament the reform will lead to changes in legislation. The government has given the proposal to the Parliament in summer 2005 and legislation is proposed to be effective from January 1, 2006 onwards.
|Privatwirtschaft, privater Sektor|
|Pharmaceutical Industy||sehr groß||kein|
The implementation of the planned reform would mainly be carried out by the government and governmental agencies (including the Social Insurance Institution, the Pharmaceutical Pricing Board, and the National Agency of Medicines). Important stakeholders implementing changes in the sale of nicotine replacement products are grocery and other retail shops, and the municipalities which would be responsible for granting licences and supervising the shops according to the draft bill.
Monitoring and evaluation of the reformed legislation are carried out by the Ministry of Social Affairs and Health, the Social Security Institution and the National Agency of Medicines. However, it is not explicitly stated how and when this would be done.
If the legislation changes are accepted by the Parliament as proposed, it would decrease pharmaceutical expenses in the long run. However, changes for generic substitution could have a major
increasing impact on drug expenditure.
It is assumed that smoking is reduced by this reform. An undesirable effect noted by the pharmacist lobby could be that nicotine dependency may increase when nicotine replacement products
|Qualität||kaum Einfluss||starker Einfluss|
|Gerechtigkeit||System weniger gerecht||System gerechter|
|Kosteneffizienz||sehr gering||sehr hoch|
The impact of this policy for cost-efficiency of pharmaceutical care is positive, except the change of the generic substitution which would increase prices with no benefit for the patients or public health care system.
Hallituksen esitys Eduskunnalle laiksi sairausvakuutuslain muuttamisesta, HE 97/2005 [In Finnish]
Hallituksen esitys Eduskunnalle laiksi lääkelain muuttamisesta, HE 107/2005 [In Finnish]
Hallituksen esitys Eduskunnalle laiksi lääkelain muuttamisesta, HE 108/2005 [In Finnish]