5.6 Pharmaceutical care

Thursday, 05. May 2011, 1:00


5.5 Emergency care


5.7 Rehabilitation / intermediate care

For regulation of pharmaceuticals see section 2.8.4 Regulation and governance of pharmaceuticals.

Before entering the market in Slovakia, pharmaceuticals must have an authorization from the EMA, or the national-level SIDC. As of 1 October 2008, with the exception of homeopathic remedies, 26 141 pharmaceuticals have been authorized, 24 198 of which are prescription pharmaceuticals and 1943 are OTC pharmaceuticals. Approximately 100 companies (for example wholesalers and pharmaceutical companies) have a licence to distribute pharmaceuticals and medical devices, but just 11 companies cover 90% of the market.

Self-governing regions issue permits to open pharmacies according to the conditions outlined in law. Every health insurance company is obliged to contract each pharmacy. There were 1639 pharmacies in Slovakia in 2007, or one pharmacy per 3295 people (Table 5.3). The distribution of pharmacies in Slovakia shows regional disparities. The most dense network of pharmacies is in the Bratislava region (2450 people per pharmacy in 2007), while the highest number of people per pharmacy is in Zilina region (4087 in 2007) (Table 5.3). Since 2006, the number of pharmacies has increased as a result of legislative changes, which simplified the entry of new pharmacies to the market. Contrary to previous rules, a new pharmacy can be established regardless of its distance from the existing pharmacies. Non-pharmacists are allowed to own a pharmacy, but must guarantee a trained pharmacist at the premises.

Table 5.3: Number of pharmacies and number of inhabitants per pharmacy on average and in the self-governing regions, 2000–2007

In 2003, a user fee of €0.67 (20 SKK at that time) for each prescription was introduced, which was reduced to €0.17 (5 Sk) in 2006. In addition to the maximum reimbursement level and resulting co-payments (see section 3.4 and section 2.8.4 Regulation and governance of pharmaceuticals) can specify certain restrictions on prescribing and indications. If a restriction on prescribing applies, the pharmaceutical can only be prescribed by a GP for a period of six months upon recommendation from a specialist. After this period, the specialist must re-evaluate the patient’s condition and the pharmaceutical’s effectiveness and decide whether to continue the treatment. For pharmaceuticals with restricted indication, reimbursement is based on the user’s health status, specific test results or a failure of other treatment options. The physician must comply with the restrictions on indication in order to have the treatment covered by SHI. Physicians may also approach health insurance companies with requests to make an exception and reimburse a specific therapeutic procedure that does not fall within the defined restrictions. The decision is at the discretion of the health insurance company.

Generic substitution in Slovakia was introduced in 2005. It is only allowed between pharmaceuticals with the same effective substance. The Ministry of Health issues a list of effective substances in which generic substitution is prohibited. These are not necessarily pharmaceuticals from the same reference pricing group. When providing advice on treatment, physicians must inform their patients about cheaper generic alternatives available in the market. If necessary, they can also prohibit the use of generic substitutes for particular patients. Pharmacists must inform patients about generics when filling a prescription. If the physician did not provide any reason not to use the generic substitute, the patient may choose the less expensive option.

In 2009, the total expenditure on pharmaceuticals in outpatient care from public resources was €987.6 million, or approximately €183 per capita (NCHI, 2010a). Compared to EU15 countries, Slovakia has low pharmaceutical expenditure per capita in absolute terms, but it nevertheless accounted for almost 33.6% of public expenditure on health care in 2007 (HCSA, 2008), the highest share for pharmaceutical expenditure of all OECD countries (OECD, 2009). For more information on pharmaceutical spending see section 7.3.

Expenditures on pharmaceuticals have more than doubled in nominal terms since 1998. An expansive phase of 18% of annual growth from 1999 to 2002, which was caused by an increase in prices, was followed by a short spell of negative growth between 2003 and 2004, due to the introduction of user fees for doctor visits and prescriptions in mid 2003 (see Fig. 5.3). Based on changes to pharmaceutical reimbursement in November 2003, co-payments were increased due to strict reference pricing measures, followed by a reduction of pharmaceutical prices resulting from market competition. Drug expenditures rose again from 2005 to 2007 when a VAT reduction from 19% to 10% came into effect, and a reduction of prices by 6.6% was observed due to the strengthening of the Slovak crown against the euro and the US dollar. Also in 2008, the strengthening of the crown led to a reduction of pharmaceutical prices. The implementation of degressive margins in 2008 also aimed at achieving cost savings. Analyses have proved that many pharmaceutical prices in Slovakia are higher in comparison with other countries (Szalayová, 2007). Based on these analyses, the Ministry of Health in cooperation with the Ministry of Finance started to perform a re-evaluation of all pharmaceutical prices on the reimbursement list in 2009.

Although pharmaceutical expenditure has been constantly rising, the volume of consumed pharmaceuticals in millions of prescribed packages has been quite stable. After a moderate decrease until 2004, recent years have shown moderate increases again, but the numbers have not reached the levels of 2000. Patient co-payments for pharmaceuticals covered by SHI have been growing faster than pharmaceutical expenditure from public resources (see Fig. 5.4). Yet co-payments account for no more than 15% of total pharmaceutical expenditure.

Fig. 5.3: Trend in public expenditures on pharmaceuticals in SKKa (billion) and annual growth (%)

Fig 5.4: Trend in public expenditure on pharmaceuticals and patient co-payments in SKKa (billion) and trend in number of prescribed pharmaceuticals (million packages)

Cardiovascular pharmaceuticals represent the highest share of expenditures and treatment packs in Slovakia. The share of total pharmaceutical expenditures in cardiovascular drugs has been decreasing continuously due to the expiry of patent protection followed by a reduction in prices, not due to decrease in use. In terms of expenditure, oncological and immunomodulant pharmaceuticals, with a 30% average annual growth in the past five years, represent the group with the most significant growth (data from NCHI, 2006–2010).